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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 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 698 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01108510
The ClinicalTrials.gov registry entry for NCT01108510 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 698 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which FTC/TDF is the first listed.
NCT01108510 reports 0 study locations.
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.
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