Completed

A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.

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What is being tested

Stavudine

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: January 1995
See protocol details

Summary

Principal SponsorBristol-Myers Squibb
Last updated: April 14, 2011
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1995

Actual date on which the first participant was enrolled.

Patients receive d4T or placebo every 12 hours for 4 weeks, after which dose decreases (or placebo) every 12 hours. Treatment continues for at least 48 weeks.

NCT00002349
Principal SponsorBristol-Myers Squibb
Last updated: April 14, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAIDS-Related ComplexHIV Infections

Criteria

Inclusion Criteria Patients must have: Recent HIV infection. No prior antiretroviral therapy. No acute opportunistic infection at study entry. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Intractable diarrhea. Bilateral peripheral neuropathy. Any other condition that would preclude study therapy. Concurrent Medication: Excluded: Myelosuppressive, neurotoxic, or hepatotoxic drugs. Patients with the following prior condition are excluded: History of bilateral peripheral neuropathy. Prior Medication: Excluded: Prior antiretroviral therapy. Myelosuppressive, neurotoxic, or cytotoxic agents within 3 months prior to study entry.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

San Diego Naval Hosp

San Diego, United StatesOpen San Diego Naval Hosp in Google Maps

Naval Med Ctr

Portsmouth, United States

Northwest Med Ctr

Seattle, United States
Completed3 Study Centers