A Study to Evaluate the Use of Stavudine (d4T) to Treat AIDS Dementia Complex

Completed · Phase 3

Conditions studied: AIDS Dementia Complex, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002246

Run by

Bristol-Myers Squibb

People needed

20

Starts

1997-10-01

Expected to finish

1999-03-01

Last updated by the study team

2011-05-04

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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