CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 3,526 enrolled
Drug / intervention
Atazanavir +9 moredrug
Likely dose
Multiple regimen options available (Atazanavir 300 mg daily, Efavirenz 600 mg daily, Emtricitabine/Tenofovir 200/300 mg daily, Lopinavir/Ritonavir 200/50 mg daily, Nevirapine 200 mg daily×14 days then 200 mg BID, Stavudine weight-based, Tenofovir 300 mg daily, or Zidovudine/Lamivudine 300/150 mg BID)AI-extracted
Key inclusion· 6
  • ✓HIV-infected partner: positive HIV test within 60 days
  • ✓HIV-infected partner: CD4 count 350–550 cells/mm³ within 30 days
  • ✓HIV-uninfected partner: negative HIV test within 14 days
  • ✓Both partners plan to maintain sexual relationship and have had sex (vaginal or anal) ≥3 times in past 3 months
Key exclusion· 8
  • ✕HIV-infected partner with current or previous AIDS-defining illness or opportunistic infection
  • ✕Acute hepatitis within 30 days if assigned nevirapine or atazanavir regimen
  • ✕Any acute hepatitis within 30 days prior to entry
  • ✕Active drug or alcohol dependence that would interfere with study participation

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

Search/NCT00074581
NCT00074581Phase 3Completed
CompareCT.gov

A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Dec 17, 2003·Updated Nov 5, 2021

In Brief

A Phase 3 clinical trial evaluating Atazanavir, Didanosine, and 8 other interventions for HIV Infections. Completed, enrolled 3,526 participants across 17 sites in 9 countries.

Detailed Summary

This study will determine whether anti-HIV drugs can prevent the sexual transmission of HIV among couples in which one partner is HIV infected and the other is not.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBotswana, Brazil, India, Kenya, Malawi, South Africa, Thailand, United States, Zimbabwe
CollaboratorsHIV Prevention Trials Network

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 17, 2003
Enrollment StartFeb 1, 2005
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 22.5 years ago

Interventions

Atazanavirdrug

300 mg taken orally once daily

Didanosinedrug

400 mg taken orally once daily

Efavirenzdrug

600 mg taken orally once daily

Emtricitabine/Tenofovir disoproxil fumaratedrug

200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily

Lamivudinedrug

300 mg taken orally once daily

Lopinavir/Ritonavirdrug

200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily

Nevirapinedrug

200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily

Stavudinedrug

Dosage depends on weight

Tenofovir disoproxil fumaratedrug

300 mg taken orally once daily

Zidovudine/Lamivudinedrug

150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily