HIV InfectionsPhase 3NCT00369941
A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT)
A Phase 3 study testing MK-0518, Comparator: efavirenz and Comparator: Truvada in people with HIV Infections, run by Merck Sharp & Dohme LLC.
Trial summary
This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infections
- What is being tested?
- MK-0518, Comparator: efavirenz and Comparator: Truvada
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 566 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Feb 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is a male or female at least 18 years of age
- Participant is HIV positive
- Participant is naïve to antiretroviral therapy (ART) and has not received any ART
Who cannot join
- Participant has received approved or experimental antiretroviral agents in the past
- Participant has been treated for a viral infection other than HIV such as hepatitis B virus infection with an agent that is active against HIV including but not limited to adefovir or lamivudine (= 7 days total)
- Participant has documented resistance to tenofovir, emtricitabine, and/or efavirenz
- Participant has used another experimental HIV-integrase inhibitor
- Participant has a current (active) diagnosis of acute hepatitis due to any cause
- Participants with chronic hepatitis including chronic hepatitis B and/or C may enter the study as long as they have stable liver function tests
About this study
Official title: A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™
This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.
- Conditions
- HIV Infections
- Being tested
- MK-0518, Comparator: efavirenz, Comparator: Truvada, Comparator: Placebo to MK-0518, Comparator: Placebo to efavirenz
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK-0518Drug
Also called raltegravir, Isentress®
400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks
Comparator: efavirenzDrug
Also called Sustiva®
600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks
Comparator: TruvadaDrug
Also called emtricitabine/tenofovir disoproxil fumarate
One tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir)
Comparator: Placebo to MK-0518Drug
Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks
Comparator: Placebo to efavirenzDrug
Placebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks
| Study group | Role | What they receive |
|---|---|---|
| MK-0518 400 mg b.i.d. | Experimental | MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min. Receives: Drug: MK-0518; Drug: Comparator: Truvada; Drug: Comparator: Placebo to efavirenz |
| Efavirenz 600 mg q.h.s. | Active comparator | Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min. Receives: Drug: Comparator: efavirenz; Drug: Comparator: Truvada; Drug: Comparator: Placebo to MK-0518 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48.
Measured: 48 Weeks
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: 48 Weeks
Number of Participants With Serious CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: 48 Weeks
Number of Participants With Drug-related CAEs at Week 48
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 48 Weeks
Number of Participants With Serious Drug-related CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 48 Weeks
Number of Participants That Died by Week 48
All participant deaths in the span of 48 weeks on study were recorded.
Measured: 48 Weeks
Number of Participants That Discontinued With CAEs at Week 48
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: 48 Weeks
Number of Participants That Discontinued With Serious CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: 48 Weeks
Number of Participants That Discontinued With Drug-related CAEs at Week 48
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 48 Weeks
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 48 Weeks
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Measured: 48 Weeks
Number of Participants With Serious LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: 48 Weeks
Number of Participants With Drug-related LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 48 Weeks
Number of Participants With Serious Drug-related LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 48 Weeks
Number of Participants Discontinued With LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Measured: 48 Weeks
Number of Participants Discontinued With Drug-related LAEs at Week 48
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse events (AEs) in this study were defined as "drug-related" if the investigator considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone.
Measured: 48 Weeks
Secondary outcomes (57)
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 48.
Measured: 48 Weeks
Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48
Mean change from baseline at Week 48 in CD4 cell count (cells/mm3)
Measured: Baseline and Week 48
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 96.
Measured: 96 Weeks
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 96.
Measured: 96 Weeks
Change From Baseline in CD4 Cell Count at Week 96
Mean change from baseline at Week 96 in CD4 cell count (cells/mm3)
Measured: Baseline and Week 96
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 156.
Measured: 156 Weeks
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 156.
Measured: 156 Weeks
Change From Baseline in CD4 Cell Count at Week 156
Mean change from baseline at Week 156 in CD4 cell count (cells/mm3)
Measured: Baseline and Week 156
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 240.
Measured: 240 Weeks
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <400 copies/mL at Week 240.
Measured: 240 Weeks
Change From Baseline in CD4 Cell Count at Week 240
Mean change from baseline at Week 240 in CD4 cell count (cells/mm3)
Measured: Baseline and Week 240
Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8
Participants with dizziness, insomnia, somnolence, concentration impaired, depression, nightmare, confusional state, suicidal ideation, nervous system disorder, psychotic disorder, abnormal dreams, suicide attempt, acute psychosis, delirium, depressed level of consciousness, hallucination, auditory hallucination, completed suicide, and major depression
Measured: 8 Weeks
Number of Participants With CAEs at Week 96
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: 96 Weeks
Number of Participants With CAEs at Week 156
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: 156 Weeks
Number of Participants With CAEs at Week 240
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: 240 Weeks
Number of Participants With Serious CAEs at Week 96
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: 96 Weeks
Number of Participants With Serious CAEs at Week 156
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: 156 Weeks
Number of Participants With Serious CAEs at Week 240
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: 240 Weeks
Number of Participants With Drug-related CAEs at Week 96
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 96 Weeks
Number of Participants With Drug-related CAEs at Week 156
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 156 Weeks
Number of Participants With Drug-related CAEs at Week 240
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 240 Weeks
Number of Participants With Serious Drug-related CAEs at Week 96
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 96 Weeks
Number of Participants With Serious Drug-related CAEs at Week 156
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 156 Weeks
Number of Participants With Serious Drug-related CAEs at Week 240
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 240 Weeks
Number of Participants That Died by Week 96
All participant deaths in the span of 96 weeks on study were recorded.
Measured: 96 Weeks
Number of Participants That Died by Week 156
All participant deaths in the span of 156 weeks on study were recorded.
Measured: 156 Weeks
Number of Participants That Died by Week 240
All participant deaths in the span of 240 weeks on study were recorded.
Measured: 240 Weeks
Number of Participants That Discontinued With CAEs at Week 96
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: 96 Weeks
Number of Participants That Discontinued With CAEs at Week 156
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: 156 Weeks
Number of Participants That Discontinued With CAEs at Week 240
An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Measured: 240 Weeks
Number of Participants That Discontinued With Drug-related CAEs at Week 96
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 96 Weeks
Number of Participants That Discontinued With Drug-related CAEs at Week 156
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 156 Weeks
Number of Participants That Discontinued With Drug-related CAEs at Week 240
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 240 Weeks
Number of Participants That Discontinued With Serious CAEs at Week 96
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: 96 Weeks
Number of Participants That Discontinued With Serious CAEs at Week 156
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: 156 Weeks
Number of Participants That Discontinued With Serious CAEs at Week 240
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: 240 Weeks
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 96 Weeks
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 156 Weeks
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 240 Weeks
Number of Participants With LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Measured: 96 Weeks
Number of Participants With LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Measured: 156 Weeks
Number of Participants With LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Measured: 240 Weeks
Number of Participants With Drug-related LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 96 Weeks
Number of Participants With Drug-related LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 156 Weeks
Number of Participants With Drug-related LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 240 Weeks
Number of Participants With Serious LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: 96 Weeks
Number of Participants With Serious LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: 156 Weeks
Number of Participants With Serious LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Measured: 240 Weeks
Number of Participants With Serious Drug-related LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 96 Weeks
Number of Participants With Serious Drug-related LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 156 Weeks
Number of Participants With Serious Drug-related LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 240 Weeks
Number of Participants Discontinued With LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Measured: 96 Weeks
Number of Participants Discontinued With LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Measured: 156 Weeks
Number of Participants Discontinued With LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Measured: 240 Weeks
Number of Participants Discontinued With Drug-related LAEs at Week 96
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 96 Weeks
Number of Participants Discontinued With Drug-related LAEs at Week 156
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 156 Weeks
Number of Participants Discontinued With Drug-related LAEs at Week 240
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Measured: 240 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionMay 2009
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00369941
- Sponsor's protocol ID
- 0518-021
- Other IDs
- MK-0518-021, 2006_519
- Status last verified
- Feb 2017
- First submitted
- 29 Aug 2006
- Last updated
- 21 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Publications
Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, Zhao J, Xu X, Williams-Diaz A, Rodgers AJ, Barnard RJ, Miller MD, DiNubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK investigators. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009 Sep 5;374(9692):796-806. doi: 10.1016/S0140-6736(09)60918-1. Epub 2009 Aug 3.
PubMed 19647866DeJesus E, Rockstroh JK, Lennox JL, Saag MS, Lazzarin A, Zhao J, Wan H, Rodgers AJ, Walker ML, Miller M, DiNubile MJ, Nguyen BY, Teppler H, Leavitt R, Sklar P; STARTMRK Investigators. Efficacy of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naive HIV-1-infected patients: week-192 overall and subgroup analyses from STARTMRK. HIV Clin Trials. 2012 Jul-Aug;13(4):228-32. doi: 10.1310/hct1304-228.
PubMed 22849964Rockstroh JK, Lennox JL, Dejesus E, Saag MS, Lazzarin A, Wan H, Walker ML, Xu X, Zhao J, Teppler H, Dinubile MJ, Rodgers AJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK Investigators. Long-term treatment with raltegravir or efavirenz combined with tenofovir/emtricitabine for treatment-naive human immunodeficiency virus-1-infected patients: 156-week results from STARTMRK. Clin Infect Dis. 2011 Oct;53(8):807-16. doi: 10.1093/cid/cir510.
PubMed 21921224Rockstroh J, Teppler H, Zhao J, Sklar P, Harvey C, Strohmaier K, Leavitt R, Nguyen BY. Safety and efficacy of raltegravir in patients with HIV-1 and hepatitis B and/or C virus coinfection. HIV Med. 2012 Feb;13(2):127-31. doi: 10.1111/j.1468-1293.2011.00933.x. Epub 2011 May 22.
PubMed 21599819Rockstroh JK, Teppler H, Zhao J, Sklar P, Miller MD, Harvey CM, Strohmaier KM, Leavitt RY, Nguyen BY. Clinical efficacy of raltegravir against B and non-B subtype HIV-1 in phase III clinical studies. AIDS. 2011 Jul 17;25(11):1365-9. doi: 10.1097/QAD.0b013e328348065a.
PubMed 21522004Nguyen BY, Isaacs RD, Teppler H, Leavitt RY, Sklar P, Iwamoto M, Wenning LA, Miller MD, Chen J, Kemp R, Xu W, Fromtling RA, Vacca JP, Young SD, Rowley M, Lower MW, Gottesdiener KM, Hazuda DJ. Raltegravir: the first HIV-1 integrase strand transfer inhibitor in the HIV armamentarium. Ann N Y Acad Sci. 2011 Mar;1222:83-9. doi: 10.1111/j.1749-6632.2011.05972.x.
PubMed 21434946Teppler H, Brown DD, Leavitt RY, Sklar P, Wan H, Xu X, Lievano F, Lehman HP, Mast TC, Nguyen BY. Long-term safety from the raltegravir clinical development program. Curr HIV Res. 2011 Jan;9(1):40-53. doi: 10.2174/157016211794582650.
PubMed 21198432Lennox JL, Dejesus E, Berger DS, Lazzarin A, Pollard RB, Ramalho Madruga JV, Zhao J, Wan H, Gilbert CL, Teppler H, Rodgers AJ, Barnard RJ, Miller MD, Dinubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK Investigators. Raltegravir versus Efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analyses. J Acquir Immune Defic Syndr. 2010 Sep;55(1):39-48. doi: 10.1097/QAI.0b013e3181da1287.
PubMed 20404738
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA™
- ClinicalTrials.gov ID
- NCT00369941
- Acronym / sponsor ID
- 0518-021
- Conditions
- HIV Infections
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- May 2009 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 30 Aug 2006 (estimated)
- Results
- Posted 11 May 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate the safety and efficacy of MK-0518 versus efavirenz, in combination with TRUVADA, as a therapy for Human Immunodeficiency Virus (HIV)-infected patients not previously treated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MK-0518 400 mg b.i.d. | Experimental | Drug: MK-0518, Drug: Comparator: Truvada, Drug: Comparator: Placebo to efavirenzMK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min. |
| Efavirenz 600 mg q.h.s. | Active comparator | Drug: Comparator: efavirenz, Drug: Comparator: Truvada, Drug: Comparator: Placebo to MK-0518Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant is a male or female at least 18 years of age
- Participant is HIV positive
- Participant is naïve to antiretroviral therapy (ART) and has not received any ART
Key exclusion criteria (6 listed)
- Participant has received approved or experimental antiretroviral agents in the past
- Participant has been treated for a viral infection other than HIV such as hepatitis B virus infection with an agent that is active against HIV including but not limited to adefovir or lamivudine (= 7 days total)
- Participant has documented resistance to tenofovir, emtricitabine, and/or efavirenz
- Participant has used another experimental HIV-integrase inhibitor
- Participant has a current (active) diagnosis of acute hepatitis due to any cause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK-0518Also: raltegravir, Isentress®400 mg MK-0518 tablet taken by mouth (PO) twice a day (b.i.d.) for up to 240 weeks | Drug | MK-0518 400 mg b.i.d. |
| Comparator: efavirenzAlso: Sustiva®600 mg efavirenz tablet taken by mouth (PO) every night (q.h.s.) for up to 240 weeks | Drug | Efavirenz 600 mg q.h.s. |
| Comparator: TruvadaAlso: emtricitabine/tenofovir disoproxil fumarateOne tablet Truvada once a day (q.d.) for up to 240 weeks (one tablet contains 200 mg emtricitabine and 300 mg tenofovir) | Drug | Efavirenz 600 mg q.h.s., MK-0518 400 mg b.i.d. |
| Comparator: Placebo to MK-0518Placebo to MK-0518 PO b.i.d., taken for up to 240 weeks | Drug | Efavirenz 600 mg q.h.s. |
| Comparator: Placebo to efavirenzPlacebo to efavirenz PO every night (q.h.s.), taken for up to 240 weeks | Drug | MK-0518 400 mg b.i.d. |
Primary outcome
Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48
Time frame: 48 Weeks
Antiretroviral activity was evaluated for participants who achieved HIV RNA level <50 copies/mL at Week 48.
Number of Participants With Clinical Adverse Experiences (CAEs) at Week 48
Time frame: 48 Weeks
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Number of Participants With Serious CAEs at Week 48
Time frame: 48 Weeks
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Number of Participants With Drug-related CAEs at Week 48
Time frame: 48 Weeks
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Number of Participants With Serious Drug-related CAEs at Week 48
Time frame: 48 Weeks
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Number of Participants That Died by Week 48
Time frame: 48 Weeks
All participant deaths in the span of 48 weeks on study were recorded.
Number of Participants That Discontinued With CAEs at Week 48
Time frame: 48 Weeks
An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
Number of Participants That Discontinued With Serious CAEs at Week 48
Time frame: 48 Weeks
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Number of Participants That Discontinued With Drug-related CAEs at Week 48
Time frame: 48 Weeks
Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 48
Time frame: 48 Weeks
Serious CAEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Number of Participants With Laboratory Adverse Experiences (LAEs) at Week 48
Time frame: 48 Weeks
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Number of Participants With Serious LAEs at Week 48
Time frame: 48 Weeks
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose.
Number of Participants With Drug-related LAEs at Week 48
Time frame: 48 Weeks
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Number of Participants With Serious Drug-related LAEs at Week 48
Time frame: 48 Weeks
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Serious AEs are any AEs occurring at any dose that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer; or is an overdose. Adverse experiences (AEs) in this study were defined as "drug-related" if the investigator, who is a qualified physician, considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone according to his/her best clinical judgment.
Number of Participants Discontinued With LAEs at Week 48
Time frame: 48 Weeks
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product.
Number of Participants Discontinued With Drug-related LAEs at Week 48
Time frame: 48 Weeks
A laboratory AE is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the study product, whether or not considered related to the use of the product. Adverse events (AEs) in this study were defined as "drug-related" if the investigator considered the AE as possibly, probably, or definitely related to MK-0518 or efavirenz alone or in combination with TRUVADA® or to TRUVADA® alone.
57 secondary outcomes
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 48
Time frame: 48 Weeks
Change From Baseline in Cluster of Differentiation Antigen 4 (CD4) Cell Count at Week 48
Time frame: Baseline and Week 48
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 96
Time frame: 96 Weeks
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 96
Time frame: 96 Weeks
Change From Baseline in CD4 Cell Count at Week 96
Time frame: Baseline and Week 96
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 156
Time frame: 156 Weeks
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 156
Time frame: 156 Weeks
Change From Baseline in CD4 Cell Count at Week 156
Time frame: Baseline and Week 156
Number of Participants Who Achieved HIV RNA <50 Copies/mL at Week 240
Time frame: 240 Weeks
Number of Participants Who Achieved HIV RNA <400 Copies/mL at Week 240
Time frame: 240 Weeks
Change From Baseline in CD4 Cell Count at Week 240
Time frame: Baseline and Week 240
Number of Participants With Nervous System Symptoms Assessed by Review of Accumulated Safety Data up to Week 8
Time frame: 8 Weeks
Number of Participants With CAEs at Week 96
Time frame: 96 Weeks
Number of Participants With CAEs at Week 156
Time frame: 156 Weeks
Number of Participants With CAEs at Week 240
Time frame: 240 Weeks
Number of Participants With Serious CAEs at Week 96
Time frame: 96 Weeks
Number of Participants With Serious CAEs at Week 156
Time frame: 156 Weeks
Number of Participants With Serious CAEs at Week 240
Time frame: 240 Weeks
Number of Participants With Drug-related CAEs at Week 96
Time frame: 96 Weeks
Number of Participants With Drug-related CAEs at Week 156
Time frame: 156 Weeks
Number of Participants With Drug-related CAEs at Week 240
Time frame: 240 Weeks
Number of Participants With Serious Drug-related CAEs at Week 96
Time frame: 96 Weeks
Number of Participants With Serious Drug-related CAEs at Week 156
Time frame: 156 Weeks
Number of Participants With Serious Drug-related CAEs at Week 240
Time frame: 240 Weeks
Number of Participants That Died by Week 96
Time frame: 96 Weeks
Number of Participants That Died by Week 156
Time frame: 156 Weeks
Number of Participants That Died by Week 240
Time frame: 240 Weeks
Number of Participants That Discontinued With CAEs at Week 96
Time frame: 96 Weeks
Number of Participants That Discontinued With CAEs at Week 156
Time frame: 156 Weeks
Number of Participants That Discontinued With CAEs at Week 240
Time frame: 240 Weeks
Number of Participants That Discontinued With Drug-related CAEs at Week 96
Time frame: 96 Weeks
Number of Participants That Discontinued With Drug-related CAEs at Week 156
Time frame: 156 Weeks
Number of Participants That Discontinued With Drug-related CAEs at Week 240
Time frame: 240 Weeks
Number of Participants That Discontinued With Serious CAEs at Week 96
Time frame: 96 Weeks
Number of Participants That Discontinued With Serious CAEs at Week 156
Time frame: 156 Weeks
Number of Participants That Discontinued With Serious CAEs at Week 240
Time frame: 240 Weeks
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 96
Time frame: 96 Weeks
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 156
Time frame: 156 Weeks
Number of Participants That Discontinued With Serious Drug-related CAEs at Week 240
Time frame: 240 Weeks
Number of Participants With LAEs at Week 96
Time frame: 96 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19647866Lennox JL, DeJesus E, Lazzarin A, Pollard RB, Madruga JV, Berger DS, Zhao J, Xu X, Williams-Diaz A, Rodgers AJ, Barnard RJ, Miller MD, DiNubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK investigators. Safety and efficacy of raltegravir-based versus efavirenz-based combination therapy in treatment-naive patients with HIV-1 infection: a multicentre, double-blind randomised controlled trial. Lancet. 2009 Sep 5;374(9692):796-806. doi: 10.1016/S0140-6736(09)60918-1. Epub 2009 Aug 3.
- Results publication: PubMed 22849964DeJesus E, Rockstroh JK, Lennox JL, Saag MS, Lazzarin A, Zhao J, Wan H, Rodgers AJ, Walker ML, Miller M, DiNubile MJ, Nguyen BY, Teppler H, Leavitt R, Sklar P; STARTMRK Investigators. Efficacy of raltegravir versus efavirenz when combined with tenofovir/emtricitabine in treatment-naive HIV-1-infected patients: week-192 overall and subgroup analyses from STARTMRK. HIV Clin Trials. 2012 Jul-Aug;13(4):228-32. doi: 10.1310/hct1304-228.
- Results publication: PubMed 21921224Rockstroh JK, Lennox JL, Dejesus E, Saag MS, Lazzarin A, Wan H, Walker ML, Xu X, Zhao J, Teppler H, Dinubile MJ, Rodgers AJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK Investigators. Long-term treatment with raltegravir or efavirenz combined with tenofovir/emtricitabine for treatment-naive human immunodeficiency virus-1-infected patients: 156-week results from STARTMRK. Clin Infect Dis. 2011 Oct;53(8):807-16. doi: 10.1093/cid/cir510.
- Results publication: PubMed 21599819Rockstroh J, Teppler H, Zhao J, Sklar P, Harvey C, Strohmaier K, Leavitt R, Nguyen BY. Safety and efficacy of raltegravir in patients with HIV-1 and hepatitis B and/or C virus coinfection. HIV Med. 2012 Feb;13(2):127-31. doi: 10.1111/j.1468-1293.2011.00933.x. Epub 2011 May 22.
- Results publication: PubMed 21522004Rockstroh JK, Teppler H, Zhao J, Sklar P, Miller MD, Harvey CM, Strohmaier KM, Leavitt RY, Nguyen BY. Clinical efficacy of raltegravir against B and non-B subtype HIV-1 in phase III clinical studies. AIDS. 2011 Jul 17;25(11):1365-9. doi: 10.1097/QAD.0b013e328348065a.
- Results publication: PubMed 21434946Nguyen BY, Isaacs RD, Teppler H, Leavitt RY, Sklar P, Iwamoto M, Wenning LA, Miller MD, Chen J, Kemp R, Xu W, Fromtling RA, Vacca JP, Young SD, Rowley M, Lower MW, Gottesdiener KM, Hazuda DJ. Raltegravir: the first HIV-1 integrase strand transfer inhibitor in the HIV armamentarium. Ann N Y Acad Sci. 2011 Mar;1222:83-9. doi: 10.1111/j.1749-6632.2011.05972.x.
- Results publication: PubMed 21198432Teppler H, Brown DD, Leavitt RY, Sklar P, Wan H, Xu X, Lievano F, Lehman HP, Mast TC, Nguyen BY. Long-term safety from the raltegravir clinical development program. Curr HIV Res. 2011 Jan;9(1):40-53. doi: 10.2174/157016211794582650.
- Results publication: PubMed 20404738Lennox JL, Dejesus E, Berger DS, Lazzarin A, Pollard RB, Ramalho Madruga JV, Zhao J, Wan H, Gilbert CL, Teppler H, Rodgers AJ, Barnard RJ, Miller MD, Dinubile MJ, Nguyen BY, Leavitt R, Sklar P; STARTMRK Investigators. Raltegravir versus Efavirenz regimens in treatment-naive HIV-1-infected patients: 96-week efficacy, durability, subgroup, safety, and metabolic analyses. J Acquir Immune Defic Syndr. 2010 Sep;55(1):39-48. doi: 10.1097/QAI.0b013e3181da1287.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK-0518, Comparator: efavirenz and Comparator: Truvada in people with HIV Infections, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Achieved Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) <50 Copies/mL at Week 48 (time frame: 48 Weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00369941, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2017.