HIV InfectionsPhase 2NCT00105157

Safety and Efficacy of an Investigational Drug in Human Immunodeficiency Virus (HIV)-Infected Patients Failing Current Antiretroviral Therapies (0518-005)(COMPLETED)

A Phase 2 study testing Comparator: MK0518 and MK0518 in people with HIV Infections and Acquired Immunodeficiency Syndrome, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections, Acquired Immunodeficiency Syndrome
What is being tested?: Comparator: MK0518 and MK0518
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 179 participants
Where: No sites listed yet
Study dates: Mar 2005to Jul 2009
Phase: Phase 2
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

Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study
Patient must be currently on antiretroviral therapy (ART)

Who cannot join

Patient less than 18 years of age
Additional exclusion criteria will be discussed and identified by the study doctor

About this study

Official title: Multicenter Study to Evaluate the Safety and Efficacy of MK0518 in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance

This study will investigate the safety and efficacy of different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.

Conditions: HIV Infections, Acquired Immunodeficiency Syndrome
Being tested: Comparator: MK0518, MK0518, Placebo
Medical subject headings: HIV Infections, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Comparator: MK0518Drug
Also called MK0518
MK0518 oral tablets 200 mg b.i.d, for 24 weeks
MK0518Drug
MK0518 oral tablets 400 mg b.i.d, for 24 weeks
MK0518Drug
MK0518 oral tablets 600 mg b.i.d, for 24 weeks
PlaceboDrug
Placebo to MK0518, oral tablet b.i.d, for 24 weeks

Study groups in NCT00105157
Study group	Role	What they receive
1	Experimental	MK0518 200 mg Receives: Drug: Comparator: MK0518
2	Experimental	MK0518 400 mg Receives: Drug: MK0518
3	Experimental	MK0518 600 mg Receives: Drug: MK0518
4	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24
Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients
Measured: Baseline and Week 24

Secondary outcomes (43)

Number of Patients With Virologic Responses at Week 24
Number of patients who achieve HIV RNA <400 copies/mL; HIV RNA level <50 copies/mL at Week 24; or reduction from baseline in HIV RNA (log10 copies/mL) exceeding 1.0 log10 copies/mL at Week 24; at Week 24
Measured: 24 weeks
Change From Baseline in CD4 Cell Count at Week 24
Mean change from baseline at Week 24 in CD4 Cell Count (cells/mm3)
Measured: Baseline and Week 24
Number of Patients With Clinical Adverse Experiences (CAEs) at 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 SPONSOR'S product, whether or not considered related to the use of the product
Measured: 48 weeks
Number of Patients With Serious CAEs at 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
Measured: 48 weeks
Number of Patients With Drug-related CAEs at 48 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Measured: 48 weeks
Number of Patients With Serious Drug-related CAEs at 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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
Measured: 48 weeks
Number of Patients That Died by 48 Weeks
Measured: 48 weeks
Number of Patients That Discontinued With CAEs at 48 Weeks
Measured: 48 weeks
Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks
Measured: 48 weeks
Number of Patients That Discontinued With Serious CAEs at 48 Weeks
Measured: 48 weeks
Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks
Measured: 48 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Measured: 48 weeks
Number of Patients With Drug-related LAEs at 48 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Measured: 48 weeks
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks
Measured: 48 weeks
Number of Patients Discontinued With Drug-related LAEs at 48 Weeks
Measured: 48 weeks
Number of Patients With Clinical Adverse Experiences (CAEs) at 96 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 SPONSOR'S product, whether or not considered related to the use of the product
Measured: 96 weeks
Number of Patients With Serious CAEs at 96 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
Measured: 96 weeks
Number of Patients With Drug-related CAEs at 96 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Measured: 96 weeks
Number of Patients With Serious Drug-related CAEs at 96 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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
Measured: 96 weeks
Number of Patients That Died by 96 Weeks
Measured: 96 weeks
Number of Patients That Discontinued With CAEs at 96 Weeks
Measured: 96 weeks
Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks
Measured: 96 weeks
Number of Patients That Discontinued With Serious CAEs at 96 Weeks
Measured: 96 weeks
Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks
Measured: 96 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Measured: 96 weeks
Number of Patients With Drug-related LAEs at 96 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Measured: 96 weeks
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks
Measured: 96 weeks
Number of Patients Discontinued With Drug-related LAEs at 96 Weeks
Measured: 96 weeks
Number of Patients With Clinical Adverse Experiences (CAEs) at 168 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 SPONSOR'S product, whether or not considered related to the use of the product
Measured: 168 weeks
Number of Patients With Serious CAEs at 168 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
Measured: 168 weeks
Number of Patients With Drug-related CAEs at 168 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) CAEs
Measured: 168 weeks
Number of Patients With Serious Drug-related CAEs at 168 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. Drug-related are as assessed by an investigator who is a qualified physician according to his/her best clinical judgment.
Measured: 168 weeks
Number of Patients That Died by 168 Weeks
Measured: 168 weeks
Number of Patients That Discontinued With CAEs at 168 Weeks
Measured: 168 weeks
Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks
Measured: 168 weeks
Number of Patients That Discontinued With Serious CAEs at 168 Weeks
Measured: 168 weeks
Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks
Measured: 168 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks
A laboratory adverse experience (LAE) is defined as any unfavorable and unintended change in the chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product
Measured: 168 weeks
Number of Patients With Serious LAEs at 168 Weeks
Serious LAEs are any LAEs 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: 168 weeks
Number of Patients Discontinued With Drug-related LAEs at 168 Weeks
Measured: 168 weeks
Number of Patients With Drug-related LAEs at 168 Weeks
Patients with drug-related (as assessed by an investigator who is a qualified physician according to his/her best clinical judgment) LAEs
Measured: 168 weeks
Number of Patients With Serious Drug-related LAEs at 168 Weeks
Serious LAEs are any LAEs 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: 168 weeks
Number of Patients Discontinued With LAEs at 168 Weeks
Measured: 168 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2005Jul 2009

First posted9 Mar 2005 (estimated)
Study startMar 2005
Primary completionOct 2006
Study completionJul 2009

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 (1)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 179 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00105157
Sponsor's protocol ID: 0518-005
Other IDs: MK0518-005, 2005_007
Status last verified: Dec 2015
First submitted: 8 Mar 2005
Last updated: 4 Dec 2015
Results posted: Yes, on ClinicalTrials.gov

Publications

Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007 Apr 14;369(9569):1261-1269. doi: 10.1016/S0140-6736(07)60597-2.
PubMed 17434401

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Study to Evaluate the Safety and Efficacy of MK0518 in Combination With An Optimized Background Therapy (OBT), Versus OBT Alone, in HIV-Infected Patients With Documented Resistance
ClinicalTrials.gov ID: NCT00105157
Acronym / sponsor ID: 0518-005
Conditions: HIV Infections, Acquired Immunodeficiency Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 179 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Mar 2005
Primary completion: Oct 2006 (actual)
Study completion: Jul 2009 (actual)
First posted: 9 Mar 2005 (estimated)
Results: Posted 12 Apr 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 different doses of an investigational drug (MK0518) as a therapy for HIV-infected patients failing current antiretroviral therapies.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: Comparator: MK0518MK0518 200 mg
2	Experimental	Drug: MK0518MK0518 400 mg
3	Experimental	Drug: MK0518MK0518 600 mg
4	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patient must be HIV positive with Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) values that are within ranges required by the study
Patient must be currently on antiretroviral therapy (ART)

Key exclusion criteria (2 listed)

Patient less than 18 years of age
Additional exclusion criteria will be discussed and identified by the study doctor

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
Comparator: MK0518Also: MK0518MK0518 oral tablets 200 mg b.i.d, for 24 weeks	Drug	1
MK0518MK0518 oral tablets 400 mg b.i.d, for 24 weeks	Drug	2
MK0518MK0518 oral tablets 600 mg b.i.d, for 24 weeks	Drug	3
PlaceboPlacebo to MK0518, oral tablet b.i.d, for 24 weeks	Drug	4

Primary outcome

Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24
Time frame: Baseline and Week 24
Mean change from baseline at Week 24 in HIV RNA (log10 copies/mL) in all patients

43 secondary outcomes

Number of Patients With Virologic Responses at Week 24
Time frame: 24 weeks
Change From Baseline in CD4 Cell Count at Week 24
Time frame: Baseline and Week 24
Number of Patients With Clinical Adverse Experiences (CAEs) at 48 Weeks
Time frame: 48 weeks
Number of Patients With Serious CAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients With Drug-related CAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients With Serious Drug-related CAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients That Died by 48 Weeks
Time frame: 48 weeks
Number of Patients That Discontinued With CAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients That Discontinued With Drug-related CAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients That Discontinued With Serious CAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients That Discontinued With Serious Drug-related CAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs) at 48 Weeks
Time frame: 48 weeks
Number of Patients With Drug-related LAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 48 Weeks
Time frame: 48 weeks
Number of Patients Discontinued With Drug-related LAEs at 48 Weeks
Time frame: 48 weeks
Number of Patients With Clinical Adverse Experiences (CAEs) at 96 Weeks
Time frame: 96 weeks
Number of Patients With Serious CAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients With Drug-related CAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients With Serious Drug-related CAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients That Died by 96 Weeks
Time frame: 96 weeks
Number of Patients That Discontinued With CAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients That Discontinued With Drug-related CAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients That Discontinued With Serious CAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients That Discontinued With Serious Drug-related CAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs) at 96 Weeks
Time frame: 96 weeks
Number of Patients With Drug-related LAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients Discontinued With Laboratory Adverse Experiences (LAEs) at 96 Weeks
Time frame: 96 weeks
Number of Patients Discontinued With Drug-related LAEs at 96 Weeks
Time frame: 96 weeks
Number of Patients With Clinical Adverse Experiences (CAEs) at 168 Weeks
Time frame: 168 weeks
Number of Patients With Serious CAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients With Drug-related CAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients With Serious Drug-related CAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients That Died by 168 Weeks
Time frame: 168 weeks
Number of Patients That Discontinued With CAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients That Discontinued With Drug-related CAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients That Discontinued With Serious CAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients That Discontinued With Serious Drug-related CAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients With Laboratory Adverse Experiences (LAEs) at 168 Weeks
Time frame: 168 weeks
Number of Patients With Serious LAEs at 168 Weeks
Time frame: 168 weeks
Number of Patients Discontinued With Drug-related LAEs at 168 Weeks
Time frame: 168 weeks

Results and safety

Results posted to the registry on 12 Apr 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK0518 200 mg b.i.d.	44	30
MK0518 400 mg b.i.d.	45	31
MK0518 600 mg b.i.d.	45	33
Placebo	45	6

Primary outcome: Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24

Time frame: Baseline and Week 24. Mean (95% Confidence Interval). Unit: HIV RNA (log10 copies/mL)

Measure	MK0518 200 mg b.i.d. n = 43	MK0518 400 mg b.i.d. n = 45	MK0518 600 mg b.i.d. n = 45	Placebo n = 45
Value	-1.80 (-2.10 to -1.50)	-1.87 (-2.16 to -1.58)	-1.84 (-2.10 to -1.58)	-0.35 (-0.61 to -0.09)

Population analysed: Observed mean change from baseline in log10 Plasma HIV RNA for each group was calculated using the conventional imputation (replace HIV RNA \<400 copies/mL by 400 copies/mL if signal detected, or 200 copies/mL if signal not detected). Missing values: baseline-carry-forward for all failures or discontinued due to lack of efficacy

43 secondary outcomes are reported in the full results.

Adverse events

Time frame: 168 weeks: Due to a 3:1 randomization of MK0518 to placebo and more discontinuations for placebo in the double-blind phase, exposure for MK0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK0518	28 of 133 (21.1%)	131 of 133 (98.5%)	Not reported
Placebo	3 of 45 (6.7%)	39 of 45 (86.7%)	Not reported

Limitations and caveats (from the sponsor): Due to a 3:1 randomization of MK-0518 to placebo and more discontinuations for placebo in the doubleblind phase, exposure for MK-0518 and placebo differs significantly with follow-up times of 336.3 and 39.7 patient-years, respectively.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17434401Grinsztejn B, Nguyen BY, Katlama C, Gatell JM, Lazzarin A, Vittecoq D, Gonzalez CJ, Chen J, Harvey CM, Isaacs RD; Protocol 005 Team. Safety and efficacy of the HIV-1 integrase inhibitor raltegravir (MK-0518) in treatment-experienced patients with multidrug-resistant virus: a phase II randomised controlled trial. Lancet. 2007 Apr 14;369(9569):1261-1269. doi: 10.1016/S0140-6736(07)60597-2.

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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 2 study testing Comparator: MK0518 and MK0518 in people with HIV Infections and Acquired Immunodeficiency Syndrome, 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 2 inclusion and 2 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 4 Dec 2015. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 12 Apr 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?

Change From Baseline in Plasma HIV RNA (log10 Copies/mL) at Week 24 (time frame: Baseline and Week 24). 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 NCT00105157, which also lists 1 linked publication.

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 4 Dec 2015.