A Pilot Open Label, Multicenter Study to Evaluate the Role of Stavudine (d4T) in the Treatment of AIDS Dementia Complex
Stavudine
Blood-Borne Infections+18
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: October 1, 1997
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.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 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.
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 5 locations
HIV Neurobehavioral Research Ctr
San Diego, United StatesOpen HIV Neurobehavioral Research Ctr in Google MapsAIDS ReSEARCH Alliance
West Hollywood, United StatesMount Sinai Hosp
New York, United StatesNational Centre in HIV Epidemiology and Clinical Research
Sydney, Australia