CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,057 enrolled
Drug / intervention
ATV +3 moredrug
Likely dose
Atazanavir 300 mg orally once daily with ritonavir 100 mg orally once daily and tenofovir-emtricitabine 300-200 mg orally once daily; or Lopinavir 400 mg (3 × 133 mg capsules) orally twice daily with ritonavir and tenofovir-emtricitabine 300-200 mg orally once dailyAI-extracted
Key inclusion· 1
  • ✓HIV RNA ≥5000 c/ml
Key exclusion· 9
  • ✕Any antiretroviral therapy within 30 days prior to screening
  • ✕Prior antiviral therapy (>30 days of NRTI and/or >7 days of NNRTI or PI therapies)
  • ✕Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment
  • ✕Suspected primary (acute) HIV infection

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00272779
NCT00272779Phase 3Completed
CompareCT.gov

A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/Ritonavir With Lopinavir/Ritonavir, Each in Combination With Fixed Dose Tenofovir-Emtricitabine in HIV-1 Infected Treatment in Naive Subjects

Bristol-Myers Squibb·interventional·Posted Jan 9, 2006·Updated May 9, 2011

In Brief

A Phase 3 clinical trial evaluating ATV, RTV, and 2 other interventions for HIV Infections. Completed, enrolled 1,057 participants across 79 sites in 29 countries.

Detailed Summary

The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Dominican Republic, France, Germany, Guatemala, Hong Kong, Indonesia, Italy, Mexico, Netherlands, Panama, Peru, Portugal, Puerto Rico, Singapore, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 9, 2006
Enrollment StartNov 1, 2005
Primary CompletionJun 1, 2007
Study CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 20.5 years ago

Interventions

ATVdrug

300mg Oral capsules for 96 weeks

RTVdrug

100mg Oral Capsules for 96 weeks

Tenofovi-Emtricitabine (TDF/FTC) tabletdrug

One tablet with 300 mg - 200 mg once a day for 96 weeks.

LPVdrug

400 mg (3 133mg capsules) BID for 96 weeks