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Early Versus Standard Start of Anti-HIV Therapy for Treatment-Naive Adults in Haiti

NCT00120510 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 816

Last updated 2014-10-15

No results posted yet for this study

Summary

Anti-HIV treatment consisting of lamivudine/zidovudine (3TC/ZDV) and efavirenz (EFV) is the current standard of care for initial treatment of HIV in most areas of the world. The purpose of this study is to determine the best time to start this anti-HIV treatment in treatment-naive adults in Haiti.

Conditions

Interventions

DRUG

Efavirenz

Non-nucleoside reverse transcriptase inhibitor dosed at 600mg taken by mouth every 24 hours at bedtime

DRUG

Lamivudine/Zidovudine

Nucleoside reverse transcriptase inhibitor dosed at 150mg/300mg fixed dose combination taken by mouth every 12 hours

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Jean William Pape, MD · Cornell - GHESKIO, Institut de Laboratoire et de Recherches and Division of International Medicine and Infectious Diseases, Cornell University

  • Patrice Severe, MD · Cornell - GHESKIO, Institut de Laboratoire et de Recherches

  • Daniel W. Fitzgerald, MD · Division of International Medicine and Infectious Diseases, Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Haiti

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00120510 on ClinicalTrials.gov