Stavudine Doses for Advanced HIV Disease Treatment
This study aims to determine the appropriate doses of Stavudine for the treatment of advanced HIV disease.
Stavudine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
This study focuses on providing stavudine (d4T), a medication for HIV, to patients with advanced HIV disease. These patients have limited options as they cannot use other antiretroviral treatments due to either intolerance or ineffectiveness. The study's main goal is to make stavudine accessible to these patients. It's important because it aims to address the unmet needs of those with HIV who have run out of alternative treatment options. In this study, participants receive one of two different doses of stavudine, taken twice daily. The study evaluates the safety and effectiveness of these two dose levels. This involves monitoring how well patients tolerate the medication and how it impacts their HIV disease progression. The study does not mention any specific potential risks or benefits.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 13 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location