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The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used With and Without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs

NCT00002391 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2005-06-24

No results posted yet for this study

Summary

To compare the safety, tolerance, durability of the viral load response and the antiviral activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen. To determine the clinical efficacy of the two regimens as measured survival, disease progression, weight growth velocity, and neuropsychological or neurological changes. To assess the development of viral resistance and relative pharmacokinetics associated with each regimen.

Conditions

  • HIV Infections

Interventions

DRUG

Abacavir sulfate

DRUG

Lamivudine

DRUG

Zidovudine

Sponsors & Collaborators

  • Glaxo Wellcome

    lead INDUSTRY

Study Design

Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
12 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 NCT00002391 on ClinicalTrials.gov