A Study of Stavudine in HIV-Infected Patients Who Have Not Had Success With Other Anti-HIV Drugs
Information provided by (Responsible Party)
First received: November 2, 1999
Last updated: August 4, 2011
Last Verified: August 2011
History of Changes
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.
Drug : Stavudine
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized Blinded Evaluation of Two Doses of Stavudine (2',3'-Didehydro-2',3'-Dideoxythymidine; d4T) to Make Treatment Available to Severely Immunocompromised Patients With HIV Infection Who Have Failed or Are Intolerant of Alternative Antiretroviral Therapy|
Further study details as provided by Bristol-Myers Squibb:
|Study Completion Date:||November 1991|
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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).
- Incarcerated persons may be eligible to participate.
- 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).
- AZT, ddI, ddC, and other antiretroviral agents.
Patients with the following symptoms or conditions are excluded:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002308
Locations Show More
|United States, New Jersey|
|Bristol - Myers Squibb Co|
|Princeton, New Jersey, United States, 085434500|
Sponsors and CollaboratorsBristol-Myers Squibb
|Principal Investigator:||. .|
Additional Information:For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm
|Responsible Party:||Bristol-Myers Squibb|
|ClinicalTrials.gov Identifier:||NCT00002308 History of Changes|
|Other Study ID Numbers:||116B|
|Study First Received:||November 2, 1999|
|Last Updated:||August 4, 2011|
Keywords provided by Bristol-Myers Squibb:Acquired Immunodeficiency Syndrome
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
ClinicalTrials.gov processed this data on July 20, 2018
This information is provided by ClinicalTrials.gov.