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NCT01108510 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 698
- Enrollment target
NCT01108510: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT01108510 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 698 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01108510, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 698 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-1 infected, antiretroviral treatment-naive adults. Participants will be randomized in a 1:1 ratio. Randomization will be stratified by HIV-1 RNA level (≤ 100,000 copies/mL or \> 100,000 copies/mL) at screening.
Primary Outcome
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the prespecified time point within an allowed window of time, along with study drug discontinuation status.
Interventions
- DRUG FTC/TDF
- DRUG ATV
- DRUG RTV
- DRUG COBI
- DRUG COBI placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 698 participants |
| Start Date | 2010-04 |
| Est. Completion | 2015-04 |
| Phase | Phase 3 |
What the finished NCT01108510 record still lists
NCT01108510 is an interventional study that assigns participants to a tested intervention. The registered 698 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 5 interventions - of which FTC/TDF is the first listed.
NCT01108510 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01108510 about?
NCT01108510 is a clinical study titled "Safety and Efficacy of COBI-boosted Atazanavir Versus Ritonavir-boosted Atazanavir Each Administered With Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults". The objective of this study is to evaluate the safety and efficacy of a regimen containing cobicistat-boosted atazanavir (ATV+COBI) plus emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) fixed-dose combination (FDC) versus ritonavir-boosted atazanavir (ATV+RTV) plus FTC/TDF FDC in HIV-...
What is the current status of trial NCT01108510?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 698 participants. The study started on 2010-04. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01108510?
The interventions under investigation include: FTC/TDF (DRUG), ATV (DRUG), RTV (DRUG), COBI (DRUG), COBI placebo (DRUG).
Who is sponsoring clinical trial NCT01108510?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01108510's enrollment target sits among peer trials
698 516th of 2000 higher than 1,483 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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