drugset / Trial / NCT01620944
Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study in antiretroviral (ARV)-naïve Human immunodeficiency virus 1 (HIV-1) ribonucleic acid infected subjects is to compare the response rate at Week 48 of a daily regimen of Atazanavir (ATV)/ Ritonavir (RTV)HS 300/100 mg combined with either one additional drug \[Lamivudine (3TC) 300 mg daily\] or 2 additional drugs \[Tenofovir/Emtricitabine(TDF/FTC) 300/200 mg daily\].
Timeline
- Start
- 2012-07-31
- Primary completion
- 2013-01-22
- Completion
- 2013-01-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lamivudine | Other / unclassified | 300 mg | Oral |
| Comparator | Tenofovir | Small molecule | 300 mg | Oral |
| Comparator | emtricitabine | Other / unclassified | 200 mg | Oral |
| Background | Atazanavir | Other / unclassified | 300 mg | Oral |
| Background | Ritonavir | Other / unclassified | 100 mg | Oral |