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NCT00752856 · ClinicalTrials.gov registry record · Phase 2
Raltegravir + Lopinavir/Ritonavir Versus Efavirenz + Tenofovir + Emtricitabine in Treatment Naive Patients
A Phase 2 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT00752856: Completed Phase 2 study, sponsored by University of California, San Diego.
NCT00752856 is a Phase 2 study that has completed, run by University of California, San Diego. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00752856, a Phase 2 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study Summary
CCTG 589 is a randomized, open-label, pilot study comparing the efficacy, safety and tolerability of RAL plus LPV/r to EFV plus TDF/FTC in HIV-infected, treatment-naïve subjects. Subjects will be ineligible if they have any evidence of drug resistant virus in the past or at the time of screening (if never previously tested). Those who are found to be eligible will be randomized 1:1 to initiate either LPV/r (400/100 mg) plus RAL (400mg), both given twice-daily, or fixed dose combination of EFV (600 mg), TDF (300 mg) and FTC (200 mg) given as once-daily Atripla® for 48 weeks. Hypotheses 1. The novel nucleoside-sparing combination of LPV/r + RAL will have a faster phase 1 viral decay rate compared to standard-of-care therapy with EFV/TDF/FTC in antiretroviral-naïve patients. 1. Faster phase 1 viral decay dynamics will be associated with improved longer-term (week 48) viral suppression. 2. Faster phase 1 viral decay dynamics will be associated with accelerated early (Day 0-14) clearance of cell-associated HIV DNA. 3. Faster phase 1 viral decay dynamics will be associated with greater early (baseline to week 12) CD4+ T-cell recovery. 2. The LPV/r + RAL arm will have greater decreases in early (baseline to week 4) CD4/CD8 T-cell immune activation and apoptosis which will be associated with greater late (week 12 to week 48) CD4+ T-cell recovery. 3. Subjects treated with LPV/r + RAL arm will have smaller changes in total cholesterol and triglycerides from baseline than those receiving EFV/TDF/FTC.
Primary Outcome
Repeated HIV RNA measured at different time points (baseline, days 2, 7, 10, 14) will be treated as the outcome variable in a linear mixed-effects model. The primary fixed effects will include time, treatment group, treatment group-by-time interaction; random effects will include both intercept and slope allowing each subject to have individual baseline viral load and viral decay (rate of decrease in viral load following initiation of antiretroviral therapy). The treatment group-by- time interac
Interventions
- DRUG Kaletra + Isentress
- DRUG Atripla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2008-08-26 |
| Est. Completion | 2014-02-11 |
| Phase | Phase 2 |
What the finished NCT00752856 record still lists
NCT00752856 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Kaletra + Isentress is the first listed.
NCT00752856 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00752856 about?
NCT00752856 is a clinical study titled "Raltegravir + Lopinavir/Ritonavir Versus Efavirenz + Tenofovir + Emtricitabine in Treatment Naive Patients". CCTG 589 is a randomized, open-label, pilot study comparing the efficacy, safety and tolerability of RAL plus LPV/r to EFV plus TDF/FTC in HIV-infected, treatment-naïve subjects. Subjects will be ineligible if they have any evidence of drug resistant virus in the past or at the time of screening (if...
What is the current status of trial NCT00752856?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2008-08-26. Estimated completion is 2014-02-11.
What interventions are being tested in trial NCT00752856?
The interventions under investigation include: Kaletra + Isentress (DRUG), Atripla (DRUG).
Who is sponsoring clinical trial NCT00752856?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00752856's enrollment target sits among peer trials
51 1190th of 2000 higher than 806 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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