Trials / Completed
CompletedNCT01705574
Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women
A Randomized, Double-blind Phase 3B Study to Evaluate the Safety and Efficacy of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate Versus Ritonavir-Boosted Atazanavir Plus Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naïve Women
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 583 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | E/C/F/TDF | 150/150/200/300 mg FDC tablet administered orally with food once daily |
| DRUG | ATV | 300 mg capsule administered orally with food once daily |
| DRUG | RTV | 100 mg tablet administered orally with food once daily |
| DRUG | FTC/TDF | 200/300 mg tablet administered orally with food once daily |
| DRUG | E/C/F/TDF Placebo | Tablet administered orally with food once daily |
| DRUG | ATV Placebo | Tablet administered orally with food once daily |
| DRUG | RTV Placebo | Capsule administered orally with food once daily |
| DRUG | FTC/TDF Placebo | Tablet administered orally with food once daily |
| DRUG | E/C/F/TAF | 150/150/200/10 mg FDC tablet administered orally with food once daily |
Timeline
- Start date
- 2012-10-24
- Primary completion
- 2015-02-09
- Completion
- 2018-09-06
- First posted
- 2012-10-12
- Last updated
- 2019-09-20
- Results posted
- 2016-03-10
Locations
99 sites across 12 countries: United States, Belgium, Dominican Republic, France, Italy, Mexico, Portugal, Puerto Rico, Russia, Thailand, Uganda, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01705574. Inclusion in this directory is not an endorsement.