A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: AIDS Dementia Complex; HIV Infections
Intervention: Stavudine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
B Brew, Study Chair
Summary
The purpose of this study is to see if adding stavudine (d4T) to anti-HIV drug regimens (with
or without zidovudine, ZDV) can improve symptoms of AIDS Dementia Complex (ADC, problems
involving the brain or spinal cord) in HIV-positive patients.
Clinical Details
Official title: A Pilot Open Label, Multicenter Study to Evaluate the Role of Stavudine (d4T) in the Treatment of AIDS Dementia Complex
Study design: Treatment, Pharmacokinetics Study
Detailed description:
In this open-label, multicenter, multinational study, ZDV is replaced with d4T in
ZDV-containing regimens, or d4T is added to non-ZDV-containing regimens in 20 patients
experiencing ADC. Patients are defined as having failed treatment if they progress by one
ADC stage on the MSK (Memorial Sloan Kettering) rating scale on study (i. e., from Stage 1 to
2 or Stage 2 to 3). Patients are evaluated on a weekly basis until the dementia
deterioration is confirmed to be caused by HIV-1. The effect of d4T-containing regimens is
assessed for the following parameters: neurological status, survival, AIDS-defining
conditions, CSF (cerebrospinal fluid) and plasma viral load, CSF and blood immunological
markers, blood CD4 cell counts, and viral resistance. This study also assesses the
pharmacokinetics of d4T in the CSF and in the blood.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
You may be eligible for this study if you:
- Are HIV-positive.
- Are at least 13 years old (need consent if under 18).
- Have AIDS Dementia Complex.
- Have been on a stable anti-HIV drug regimen for at least 8 weeks prior to study
entry.
- Agree to use effective methods of birth control during the study.
- Are available for at least 16 weeks of study.
Exclusion Criteria
You will not be eligible for this study if you:
- Have ever taken d4T.
- Have a neurological (brain/spinal cord) disease, such as chronic seizures or head
injury, or certain other conditions that would interfere with your ability to complete
the study.
- Are pregnant or breast-feeding.
- Abuse alcohol or drugs.
- Have peripheral neuropathy or a newly diagnosed AIDS-defining infection that requires
treatment at the time of study enrollment.
- Have received certain medications.
- Cannot take medications by mouth.
- Have severe diarrhea for at least 7 days in a row within 30 days prior to study
entry.
Locations and Contacts
National Centre in HIV Epidemiology and Clinical Research, Sydney, Australia
Charing Cross and Westminster Med School, London SW 10, United Kingdom
HIV Neurobehavioral Research Ctr, San Diego, California 92103, United States
AIDS ReSEARCH Alliance, West Hollywood, California 90069, United States
Mount Sinai Hosp, New York, New York 100296574, 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
Starting date: October 1997
Last updated: October 1, 2007
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