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COMPLETEDPHASE3

The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine

A Randomized Double-Blind Study of Safety, Virologic and Immunological Effects of Stavudine Plus Lamivudine (3TC) Versus Zidovudine Plus Lamivudine in HIV-Infected Subjects Following At Least Six Months of Zidovudine Therapy

NCT00002371•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

To compare the magnitude and durability of the reduction in plasma HIV RNA in the two treatment groups over the first 12 weeks of treatment. To determine the safety of each of the two treatment groups.

Detailed Description

Patients will be randomized to either Stavudine (d4T) + Lamivudine (3TC) + Zidovudine placebo or Zidovudine (ZDV) + Lamivudine + Stavudine placebo. Patients whose plasma HIV RNA levels remain \>= 500 copies/ml after 8 weeks of blinded double combination therapy will have indinavir added to their treatment regimen at the week 12 visit.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have:
•At least six months of prior cumulative ZDV therapy.
•Qualifying plasma HIV RNA count of \>= 4 log10 copies/ml obtained within 2 weeks of randomization.
•Previous therapy with agents with significant systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start.
•Therapy with rifampin, rifabutin, terfenadine, astemizole, cisapride, triazolam, midazolam and ketoconazole within 2 weeks prior to starting indinavir.
•Any other prior therapy that, in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing regimen.
•Risk Behavior:
•Excluded:
•Active alcohol abuse, sufficient in the investigator's opinion, to prevent compliance with study therapy or to increase the risk of developing pancreatitis.
•Required:
+1 more criteria

Exclusion Criteria

•Co-existing Condition:
•Patients with any of the following symptoms or conditions are excluded:
•Presence of newly diagnosed AIDS defining opportunistic infection requiring acute therapy at time of enrollment.
•Intractable diarrhea (\>= 6 loose stools/day for \>= 7 consecutive days).
•Signs and symptoms of bilateral peripheral neuropathy \>= grade 2 at the time of screening.
•Inability to tolerate oral medication.
•Any other clinical conditions that in the opinion of the investigator, would make the patient unsuitable for study or unable to comply with the dosing requirements.
•Concurrent Medication:
•Excluded:
•Therapy with agents with systemic myelosuppressive, neurotoxic pancreatotoxic, hepatotoxic or cytotoxic potential.
+7 more criteria

Locations (8)

Harbor UCLA Med Ctr

Torrance, California, United States

Univ of South Florida

Tampa, Florida, United States

SUNY at Stony Brook / Division of Infectious Diseases

Stony Brook, New York, United States

Houston Clinical Research Network / Div of Montrose Clinic

Houston, Texas, United States

Univ of Utah / School of Medicine / Div of Infect Dis

Salt Lake City, Utah, United States

Sunnybrook Health Science Ctr

North York, Ontario, Canada

Montreal Gen Hosp / Div of Clin Immuno and Allergy

Montreal, Quebec, Canada

Univ of Puerto Rico School of Medicine

San Juan, Puerto Rico

Key Dates

Start Date

June 1, 1996

Primary Completion Date

December 1, 1997

Completion Date

December 1, 1997

Last Updated

May 4, 2011

Enrollment

Estimated participants

Conditions

HIV Infections

Interventions

Indinavir sulfate

DRUG

Lamivudine

DRUG

Stavudine

DRUG

Zidovudine

DRUG

Skeletal Muscle Energetics and Fatiguability in Older Individuals

NCT04142047

HIVHIV Infections

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RECRUITINGPHASE3

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

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: May 4, 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.

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The Safety and Effectiveness of Lamivudine Plus Stavudine or Zidovudine in HIV-Infected Patients Who Have Taken Zidovudine

Inclusion Criteria

Exclusion Criteria

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