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A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs | Clinical Trials | Clareo Health

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A Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs

A Randomized Study of the Long-Term Suppression of Plasma HIV RNA Levels by Triple Combination Regimens in Treatment Naive Subjects

NCT00002411•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the safety of didanosine plus stavudine plus nelfinavir (NLF) with that of zidovudine plus lamivudine plus NLF. This study also examines how long these drug combinations are effective in lowering viral load (level of HIV in the blood).

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have:
•Within 15 business days prior to randomization:
•CD4 cell count greater than or equal to 100 cells/mm3.
•HIV RNA greater than or equal to 2,000 copies/ml by Roche Amplicor Assay.

Exclusion Criteria

•Co-existing Condition:
•Patients with any of the following symptoms or conditions are excluded:
•Bilateral peripheral neuropathy.
•Intractable diarrhea.
•Proven or suspected acute hepatitis within 30 days prior to study entry.
•Concurrent Medication:
•Excluded:
•\- Therapy for any co-existing disease that may interfere with patient ability to participate in this study.
•Concurrent Treatment:
•Excluded:
+17 more criteria

Locations (32)

Sorra Research Ctr / Med Forum

Birmingham, Alabama, United States

Body Positive

Phoenix, Arizona, United States

Hill Top Research Inc

Fresno, California, United States

UCLA Med Ctr / CARE BH-412 CHS

Los Angeles, California, United States

AIDS Healthcare Foundation

Los Angeles, California, United States

West Los Angeles VAMC

Los Angeles, California, United States

Sherman Oaks Hosp Research Institute

Sherman Oaks, California, United States

Harbor UCLA Med Ctr / Research and Educational Institute

Torrance, California, United States

Yale New Haven Hosp / Nathan Smith Clinic

New Haven, Connecticut, United States

GW Med Ctr / Clinical Trials Unit

Washington D.C., District of Columbia, United States

Key Dates

Start Date

March 1, 1998

Primary Completion Date

September 1, 1999

Completion Date

September 1, 1999

Last Updated

April 25, 2011

Conditions

HIV Infections

Interventions

Nelfinavir mesylate

DRUG

Lamivudine

DRUG

Stavudine

DRUG

Zidovudine

DRUG

Didanosine

DRUG

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

NCT06694805

HIV Infections

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RECRUITING

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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RECRUITING

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: April 25, 2011Data 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 Comparison of Two Triple-Drug Combinations in Patients Who Have Never Been Treated With Anti-HIV Drugs

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness of Long-acting (LA) Cabotegravir (CAB) + Rilpivirine (RPV) LA When Given to Participants With Detectable HIV-1

Skeletal Muscle Energetics and Fatiguability in Older Individuals

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