CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,864 enrolled
Drug / intervention
Abacavir/Lamivudine +6 moredrug
Likely dose
Efavirenz 600 mg orally daily or Atazanavir 300 mg orally daily (with Ritonavir 100 mg orally daily) combined with either Emtricitabine/Tenofovir disoproxil fumarate 200 mg/300 mg orally daily or Abacavir/Lamivudine 600 mg/300 mg orally dailyAI-extracted
Key inclusion· 4
  • ✓HIV-infected individuals
  • ✓Antiretroviral naive, defined as ≤7 days of ARV treatment at any time prior to study entry
  • ✓HIV viral load >1000 copies/mL within 90 days prior to study entry
  • ✓Hepatitis B surface antigen (HBsAg) negative at study entry
Key exclusion· 6
  • ✕Known allergy/sensitivity to study drugs or their formulations
  • ✕Active alcohol or drug use that would interfere with adherence to study requirements
  • ✕Known clinically relevant cardiac conduction system disease
  • ✕Evidence of major drug resistance-associated mutation on genotype or significant resistance on phenotype at any time prior to study entry

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

Search/NCT00118898
NCT00118898Phase 3Completed
CompareCT.gov

A Phase IIIB, Randomized Trial of Open-Label Efavirenz or Atazanavir With Ritonavir in Combination With Double-Blind Comparison of Emtricitabine/Tenofovir or Abacavir/Lamivudine in Antiretroviral-Naive Subjects

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Jul 12, 2005·Updated Oct 12, 2018

In Brief

A Phase 3 clinical trial evaluating Abacavir/Lamivudine, Atazanavir, and 5 other interventions for HIV Infections. Completed, enrolled 1,864 participants across 52 sites in 2 countries.

Detailed Summary

Currently, the preferred anti-HIV regimens used in the United States consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and the nonnucleoside reverse transcriptase inhibitor (NNRTI) efavirenz (EFV). However, with new anti-HIV drugs being approved, alternative regimens need to be tested to determine if new drug combinations have increased effectiveness in treating HIV. The purpose of this study is to test the safety, tolerability, and effectiveness of four different regimens in HIV-infected adults who have never taken anti-HIV drugs.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, United States
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 12, 2005
Enrollment StartSep 1, 2005
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 21.0 years ago

Interventions

Abacavir/Lamivudinedrug

600 mg abacavir/300 mg lamivudine tablet taken orally daily

Atazanavirdrug

300 mg tablet taken orally daily

Efavirenzdrug

600 mg tablet taken orally daily

Emtricitabine/Tenofovir disoproxil fumaratedrug

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

Ritonavirdrug

100 mg tablet taken orally daily

Abacavir/Lamivudine placebodrug

Placebo tablet taken orally daily

Emtricitabine/Tenofovir disoproxil fumarate placebodrug

Placebo tablet taken orally daily