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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00002349

Enrollment

Registered

2001-08-31

Start date

1995-01-31

Completion date

1999-05-31

Last updated

2011-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

AIDS-Related Complex, Stavudine

Brief summary

To compare the antiviral effect of stavudine ( d4T ) versus placebo in patients with evidence of recent HIV infection. Also, to compare the immunologic effects and effects on quality of life of d4T in these patients.

Detailed description

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.

Interventions

DRUGStavudine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026