CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,571 enrolled
Drug / intervention
Atazanavir +5 moredrug
Likely dose
Atazanavir 400 mg orally daily plus emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally daily or alternative nucleoside backboneAI-extracted
Key inclusion· 8
  • ✓HIV-1 infected
  • ✓CD4 count fewer than 300 cells/mm3
  • ✓Absolute Neutrophil Count at least 750/mm3
  • ✓Hemoglobin at least 7.5 g/dL
Key exclusion· 10
  • ✕More than 7 days prior antiretroviral exposure (except single-dose NVP or ZDV for prevention of mother-to-child transmission)
  • ✕Acute therapy for serious medical illnesses within 14 days prior to study entry
  • ✕Radiation therapy or chemotherapy within 45 days prior to study entry
  • ✕Immunomodulator, HIV vaccine, or other investigational therapy within 30 days prior to study entry

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

Search/NCT00084136
NCT00084136Phase 4Completed
CompareCT.gov

Randomized, Open-Label Evaluation of Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Persons From Resource-Limited Settings (PEARLS) Trial

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·interventional·Posted Jun 8, 2004·Updated Oct 10, 2018

In Brief

A Phase 4 clinical trial evaluating Atazanavir, Didanosine (enteric-coated), and 4 other interventions for HIV Infections. Completed, enrolled 1,571 participants across 42 sites in 9 countries.

Detailed Summary

This study compared 3 different three-drug combinations in HIV infected individuals starting their first HIV treatment regimens. Participants were recruited from resource-limited areas in Africa, Asia, South America, Haiti, and also from the United States. The study hypothesis was each of the once daily combinations (PI based, or NNRTI based) would not have inferior efficacy compared to the twice daily NNRTI based combination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesBrazil, Haiti, India, Malawi, Peru, South Africa, Thailand, United States, Zimbabwe
CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 8, 2004
Enrollment StartMay 1, 2005
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 22.1 years ago

Interventions

Atazanavirdrug

400 mg taken orally daily

Didanosine (enteric-coated)drug

400 mg taken orally daily

Efavirenzdrug

600 mg taken orally daily

Emtricitabinedrug

200 mg taken orally daily

Emtricitabine/Tenofovir disoproxil fumaratedrug

200 mg/300 mg taken orally once daily

Lamivudine/Zidovudinedrug

150 mg/300 mg taken orally twice daily