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A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.

NCT00002199 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2005-06-24

No results posted yet for this study

Summary

To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC, defined class B/C events, survival, medical resource utilization, and the development of plasma viral genotypic and phenotypic resistance.

Conditions

  • HIV Infections

Interventions

DRUG

Indinavir sulfate

DRUG

Lamivudine/Zidovudine

DRUG

Abacavir sulfate

Sponsors & Collaborators

  • Glaxo Wellcome

    lead INDUSTRY

Study Design

Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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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 NCT00002199 on ClinicalTrials.gov