Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex
- Conditions
- AIDS Dementia ComplexHIV Infections
- Registration Number
- NCT00000657
- Brief Summary
To compare the safety and effectiveness of orally administered didanosine (ddI) with high dose orally administered zidovudine (AZT) in patients who develop or exhibit progression of the AIDS dementia complex (ADC) and who have not previously been intolerant to AZT at doses of up to 1000 mg/day.
HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system. ADC may be caused by some action of the AIDS virus on the nervous system, although similar problems can be caused by other infections because the AIDS virus lowers the body's ability to fight other infections. It is important to determine whether symptoms are due to ADC or to some other infection since treatment varies for different conditions. AZT has been shown to be beneficial to people with ADC although its effectiveness has only been studied in a small number of patients. Studies suggest that higher doses of AZT are more likely to be effective than standard doses in improving symptoms of ADC.
- Detailed Description
HIV-infected or AIDS patients may develop ADC which causes damage to the nervous system. ADC may be caused by some action of the AIDS virus on the nervous system, although similar problems can be caused by other infections because the AIDS virus lowers the body's ability to fight other infections. It is important to determine whether symptoms are due to ADC or to some other infection since treatment varies for different conditions. AZT has been shown to be beneficial to people with ADC although its effectiveness has only been studied in a small number of patients. Studies suggest that higher doses of AZT are more likely to be effective than standard doses in improving symptoms of ADC.
Patients are randomly assigned to receive either oral ddI or oral AZT.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Charity Hosp / Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Louisiana State Univ Med Ctr / Tulane Med School
🇺🇸New Orleans, Louisiana, United States
Tulane Univ School of Medicine
🇺🇸New Orleans, Louisiana, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Univ of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Univ of Rochester Medical Center
🇺🇸Rochester, New York, United States
Scroll for more (3 remaining)San Francisco AIDS Clinic / San Francisco Gen Hosp🇺🇸San Francisco, California, United States