A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002349
- Run by
- Bristol-Myers Squibb
- People needed
- 40
- Starts
- 1995-01-01
- Expected to finish
- 1999-05-01
- Last updated by the study team
- 2011-04-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must have:
- Recent HIV infection.
- No prior antiretroviral therapy.
- No acute opportunistic infection at study entry.
You may not qualify if…
- 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.
Where it is running
- San Diego Naval Hosp — San Diego, California, United States
- Naval Med Ctr — Portsmouth, Virginia, United States
- Northwest Med Ctr — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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