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A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex Clinical research trials and A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex. A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex clinical trial. Participants typically obtain the most effective healthcare available for their A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex  A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex
A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex
For Condition: AIDS Dementia Complex,HIV Infections
Status: No longer recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
BBrew, Study Chair,
AIDS ReSEARCH Alliance
West Hollywood, California, 90069
United States
Charing Cross and Westminster Med School
London SW 10, ,
United Kingdom
Mount Sinai Hosp
New York City, New York, 100296574
United States
HIV Neurobehavioral Research Ctr
San Diego, California, 92103
United States
National Centre in HIV Epidemiology and Clinical Research
Sydney, ,
Australia
Additional Information:
Study ID Numbers: 244E; AI455-064
Study Start Date: October 1997
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002246
Other Aids Dementia Complex Studies:
1. Leukapheresis to Obtain Plasma or Lymphocytes for Studies of HIV-infected Patients, including Long-term Non-progressors
2. Screening Protocol for HIV Vaccine Studies
3. Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy
4. A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Immuno-AG Recombinant HIV gp160 in Asymptomatic HIV Seropositive Individuals
5. A Study to Evaluate the Effect of Cimetidine on CD4 Lymphocyte Counts in HIV Infection
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A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex
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