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A Study of Three Treatment Combinations Using Zidovudine Plus Lamivudine Plus Indinavir in HIV-Infected Patients

NCT00001084 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2021-11-04

No results posted yet for this study

Summary

To compare the proportion of patients who sustain suppression of plasma HIV RNA to undetectable levels \[AS PER AMENDMENT 09/19/97: below 200 copies/mL by Roche UltraSensitive assay\] among the 3 regimens during the maintenance phase.

The objective of antiretroviral therapy is to reduce HIV replication, preserve immunologic function and delay the development of HIV-related complications. In patients administered potent antiretroviral regimens, HIV RNA levels are reduced below 500 copies/ml of plasma and below the level of detection of commercially available assays. This protocol attempts to learn if a less intensive regimen can successfully sustain viral suppression after induction with a triple-drug regimen. The study also addresses whether HIV can be eradicated in patients following prolonged treatment with induction and maintenance regimens.

Conditions

  • HIV Infections

Interventions

DRUG

Indinavir sulfate

DRUG

Lamivudine

DRUG

Stavudine

DRUG

Zidovudine

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Havlir D

  • Richman D

Study Design

Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Completion
1997-12-31

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 NCT00001084 on ClinicalTrials.gov