A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections
Intervention: Stavudine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
. ., ., Principal Investigator, Affiliation: .
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.
Clinical Details
Official title: A Pilot Study to Compare the Antiviral and Immunologic Effects of Stavudine ( d4T ) Versus Placebo in Subjects With Evidence of Recent HIV Infection.
Study design: Treatment, Randomized, Double-Blind, Active Control, Single Group Assignment, Efficacy Study
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
San Diego Naval Hosp, San Diego, California 921345000, United States
Naval Med Ctr, Portsmouth, Virginia 237085100, United States
Northwest Med Ctr, Seattle, Washington 98122, United States
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
Related publications: Katlama C, Molina JM, Rozenbaum W, Valantin MA, Modai J, Chauveau E, Ngo Van P, Gres JJ. Stavudine ( D4T ) in HIV infected patients with CD4 less than 350/mm3: results of a double-blind randomized placebo controlled study. Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:89
Last updated: August 15, 2007
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