A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs

Completed · Not applicable

Conditions studied: HIV Infections

In brief

To make stavudine (d4T) available to patients with advanced HIV disease for whom no alternative antiretroviral is satisfactory. To study the safety and efficacy of two dose levels in a twice-daily regimen.

Key facts

Study ID

NCT00002308

Run by

Bristol-Myers Squibb

Expected to finish

1991-11-01

Last updated by the study team

2011-08-05

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have:
• HIV positivity with CD4 count < 300 cells/mm3.
• Intolerance to or failure on approved antiretroviral therapy.
• Ability to provide informed consent (of parent or guardian if appropriate).
• NOTE:
• Incarcerated persons may be eligible to participate.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Grade 2 or worse disease-related peripheral neuropathy.
• Unresolved drug-related peripheral neuropathy of any severity that is attributable to other nucleoside analogs (AZT, ddC, ddI).
• Malignancy likely to require systemic chemotherapy with myelosuppressive or neurotoxic drugs in the first 3 months of stavudine treatment.
• Pregnancy (physicians of pregnant patients may contact Bristol-Myers to determine eligibility for stavudine therapy in another protocol).
• Strongly discouraged:
• AZT, ddI, ddC, and other antiretroviral agents.

Where it is running

• Bristol - Myers Squibb Co — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.