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

• Status: Completed
• Trial end date: 1999-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Stavudine

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.