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



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

For Condition: HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Double-Blind, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. Exclusion Criteria 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.
Total Enrollment: 

Location and Contact Information:

Bristol - Myers Squibb Co
Princeton,  New Jersey,  085434500
United States
 


Additional Information:
Study ID Numbers:
  116B;  AI455-900
Study Start Date: 
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002308

Other Hiv Infections Studies:
1. Cause of Focal Segmental Glomerulosclerosis

2. Phase II Study of Zidovudine and Recombinant Alpha-2A Interferon in the Treatment of Patients With AIDS-Associated Kaposi's Sarcoma

3. Topical Use of 4,4'-Dihydroxybenzophenone-2,4-Dinitrophenylhydrazone (A-007) in the Treatment of Advanced Malignancies Including Kaposi's Sarcoma and Lymphoproliferative Disorders

4. A Pilot Study of Allogeneic Lymphocyte Transfer in HIV Infection

5. Phase II/III Study of the Tolerance and Efficacy of Combined Use of Didanosine (2',3'-Dideoxyinosine; ddI) and Lentinan in HIV-Positive Patients

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