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.

Condition	Treatment or Intervention	Phase
AIDS Dementia Complex HIV Infections	Drug: Stavudine	Phase III

Further Study Details: 

Expected Total Enrollment:  20

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  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.

California
      HIV Neurobehavioral Research Ctr, San Diego,  California,  92103,  United States
      AIDS ReSEARCH Alliance, West Hollywood,  California,  90069,  United States
New York
      Mount Sinai Hosp, New York,  New York,  100296574,  United States
Australia
      National Centre in HIV Epidemiology and Clinical Research, Sydney,  Australia
United Kingdom
      Charing Cross and Westminster Med School, London SW 10,  United Kingdom

Study chairs or principal investigators

B Brew,  Study Chair

Study ID Numbers:  244E; AI455-064
Record last reviewed:  February 2004
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002246
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08