HIV InfectionsPhase 4NCT00632970
Raltegravir vs. Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV+ Treatment Naive Individuals
A Phase 4 study testing Raltegravir, Lopinavir/Ritonavir and Truvada in people with HIV Infections, run by George Washington University at 1 site in United States.
Trial summary
This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada. 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?
- Raltegravir, Lopinavir/Ritonavir and Truvada
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Jun 2010
- Phase
- Phase 4
- 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
- Documented HIV infection confirmed by western blot or HIV RNA.
- At least 18 years of age.
- Less than 1 week of prior antiretroviral therapy.
- In the opinion of the investigator, patients should be clinically stable. Patients may be on chronic suppressive therapy for opportunistic infections such as MAC or CMV.
- Patients who are of reproductive potential agree to use an acceptable method of birth control throughout the study. Acceptable methods include an intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence.
- HIV RNA > 5000 copies/ml. No restriction on CD4 cell count.
- A negative urine pregnancy test on the day of initiation of therapy.
Who cannot join
- Prior treatment with >1week of antiretroviral therapy.
- Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.
- HIV RNA < 5000 prior to receiving therapy.
- Baseline resistance to any of the study regimen drugs on genotype testing.
- Patients with acute hepatitis due to any cause or clinically significant chronic liver disease.
- Patient with severe renal insufficiency defined as a calculated creatinine clearance at time of screening <30mL/min, based on the Cockcroft-Gault equation which is as follows (and 0.85X this value for females): Clcr(mL/min) = (l40-age) x weight (in kg)72 x serum creatinine (mg/dL).
Show all 11Show fewer
- Patient has a condition (including but not limited to alcohol or other substance abuse) which in the opinion of the investigator would interfere with patient compliance or safety.
- A female patient who is pregnant, breast-feeding, or expecting to conceive or donate eggs during the study; or a male patient who is planning to impregnate or provide sperm donation during the study is excluded.
- Inability to obtain signed informed consent from a patient age 18 or older.
- Patient has significant hypersensitivity or other contraindication to any of the components of the study drug.
- Patients who should be treated for hyperlipidemia as per NCEPIII guidelines and patients who are currently receiving lipid-lowering therapy are excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, 20037
About this study
Official title: A Multi-Center Comparison of Raltegravir to Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV-Infected Individuals Naive to Antiretroviral Therapy
This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada.
Read the detailed description
It is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in CD4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.
- Conditions
- HIV Infections
- Being tested
- Raltegravir, Lopinavir/Ritonavir, Truvada
- Keywords
- Raltegravir, Lopinavir
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaltegravirDrug
Also called Isentress
1, 400mg tablet twice a day, with Truvada 1 tablet once a day
Lopinavir/RitonavirDrug
Also called Kaletra
2 tablets twice a day, with Truvada 1 tablet once a day
TruvadaDrug
Also called Emtricitabine/Tenofovir disoproxil fumarate
1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra)
| Study group | Role | What they receive |
|---|---|---|
| Raltegravir plus Truvada | Experimental | Raltegravir (400mg), 1 tablet, administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD) Receives: Drug: Raltegravir; Drug: Truvada |
| Lopinavir/Ritonavir plus Truvada | Active comparator | Lopinavir/Ritonavir (400mg/100mg) (Kaletra), 2 tablets administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD) Receives: Drug: Lopinavir/Ritonavir; Drug: Truvada |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute Change in CD4 Cell Counts
Measured: 24 and 48 weeks
Secondary outcomes (1)
Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010
- Study completionJun 2010
Why it stopped: no patients completed
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.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary Simon, George Washington University
- Investigators
- Gary Simon, MD, PhD, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632970
- Sponsor's protocol ID
- GS001
- Status last verified
- Aug 2018
- First submitted
- 29 Feb 2008
- Last updated
- 29 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Findings not relevant
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Comparison of Raltegravir to Lopinavir/Ritonavir, Both in Combination With Truvada, in HIV-Infected Individuals Naive to Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT00632970
- Acronym / sponsor ID
- GS001
- Conditions
- HIV Infections
- Keywords
- Raltegravir, Lopinavir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no patients completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 11 Mar 2008 (estimated)
- Results
- Posted 26 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This program is designed to study the efficacy, safety, lipid effects and tolerability of raltegravir compared to lopinavir/ritonavir, in patients with HIV-I infection who have not received prior antiretroviral therapy. All patients will receive concomitant therapy with Truvada.
Detailed description
It is hypothesized that (1) the raltegravir regimen will have similar efficacy in terms of both viral suppression as well as increases in CD4 cell counts and (2) raltegravir will have significantly less impact on plasma lipids, lipoproteins and lipoproteins subtypes, compared with lopinavir/ritonavir.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raltegravir plus Truvada | Experimental | Drug: Raltegravir, Drug: TruvadaRaltegravir (400mg), 1 tablet, administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD) |
| Lopinavir/Ritonavir plus Truvada | Active comparator | Drug: Lopinavir/Ritonavir, Drug: TruvadaLopinavir/Ritonavir (400mg/100mg) (Kaletra), 2 tablets administered twice daily (BID) and Truvada (Emtricitabine/Tenofovir disoproxil fumarate) (200mg/300mg), 1 tablet administered once daily (QD) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Documented HIV infection confirmed by western blot or HIV RNA.
- At least 18 years of age.
- Less than 1 week of prior antiretroviral therapy.
- In the opinion of the investigator, patients should be clinically stable. Patients may be on chronic suppressive therapy for opportunistic infections such as MAC or CMV.
- Patients who are of reproductive potential agree to use an acceptable method of birth control throughout the study. Acceptable methods include an intrauterine device (IUD), diaphragm with spermicide, condoms, or abstinence.
Key exclusion criteria (11 listed)
- Prior treatment with >1week of antiretroviral therapy.
- Patient requires or is anticipated to require any of the prohibited medications noted in the protocol.
- HIV RNA < 5000 prior to receiving therapy.
- Baseline resistance to any of the study regimen drugs on genotype testing.
- Patients with acute hepatitis due to any cause or clinically significant chronic liver disease.
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 |
|---|---|---|
| RaltegravirAlso: Isentress1, 400mg tablet twice a day, with Truvada 1 tablet once a day | Drug | Raltegravir plus Truvada |
| Lopinavir/RitonavirAlso: Kaletra2 tablets twice a day, with Truvada 1 tablet once a day | Drug | Lopinavir/Ritonavir plus Truvada |
| TruvadaAlso: Emtricitabine/Tenofovir disoproxil fumarate1 tablet, once a day, with either Raltegravir (Isentress) or Lopinavir/Ritonavir(Kaletra) | Drug | Lopinavir/Ritonavir plus Truvada, Raltegravir plus Truvada |
Primary outcome
Absolute Change in CD4 Cell Counts
Time frame: 24 and 48 weeks
1 secondary outcome
Change is Plasma Lipids, Lipoproteins and Lipoprotein Subtypes.
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Findings not relevant
Related trials for HIV Infections
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Gary Simon, MD, PhD principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Raltegravir, Lopinavir/Ritonavir and Truvada in people with HIV Infections, run by George Washington University at 1 site in United States.
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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 26 Jun 2017). 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?
Absolute Change in CD4 Cell Counts (time frame: 24 and 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2018.