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A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs | Clinical Trials | Clareo Health

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A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs

A Randomized Open-Label Strategic Study to Evaluate the Safety and Efficacy of 3 Different Convergent and Divergent Drug Combination Therapies in Anti-Retroviral Naive HIV-1 Infected Patients With CD4+ Counts Above 200/mm3

NCT00002407•Weill Medical College of Cornell University

View on ClinicalTrials.gov

Summary

The purpose of this study is to see if it is safe and effective to give one of three different triple-drug combinations to HIV-infected patients who have never been treated with anti-HIV drugs.

Detailed Description

In this open-label, strategic study patients are evaluated at Weeks 0, 1, 2, 4, 8, 12 to Week 48 after being treated on one of the following regimens: Stavudine (d4T) + Didanosine (ddI) + Lamivudine (3TC) or d4T + ddI + Indinavir or d4T + ddI + Nevirapine.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have:
•Diagnosed asymptomatic HIV infection.
•HIV-1 RNA greater than 500 copies/ml.
•CD4+ T-cell count greater than 200/mm3.
•Never received antiretroviral therapy.

Exclusion Criteria

•Co-existing Condition:
•Excluded:
•Severe non-HIV-related disease.
•Patients with the following prior conditions are excluded:
•History of neuropathy.
•Prior Medication:
•Excluded:
•Investigational drug within 1 month prior to study.
•Immunomodulatory drug within 1 month prior to study.
•Prior Treatment:
+3 more criteria

Locations (1)

Cornell AIDS Clinical Trials Unit

New York, New York, United States

Key Dates

Last Updated

June 24, 2005

Conditions

HIV Infections

Interventions

Indinavir sulfate

DRUG

Nevirapine

DRUG

Lamivudine

DRUG

Stavudine

DRUG

Didanosine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of Three Drug Combination Therapies in HIV-Infected Patients Who Have Never Been Treated With Anti-HIV Drugs

Inclusion Criteria

Exclusion Criteria

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