CompletedPhase 2

Comparison of 2',3'-Dideoxyinosine (Didanosine, ddI) and Zidovudine in Therapy of Patients With the AIDS Dementia Complex

United States80 participants

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria Concurrent Medication: Allowed: * Chronic suppressive therapy for herpes simplex virus, cytomegalovirus, Candida albicans, and Salmonella. * Prophylactic therapy for Pneumocystis carinii pneumonia. * Maintenance anticonvulsant therapy following a seizure in the context of the AIDS dementia complex. * Isoniazid only if no acceptable alternative therapy is available. * Judicious use of benzodiazepines, tricyclics, and other antidepressants is allowed but a stable dose level should be obtained prior to entry and maintained throughout the trial. * In patients for whom it is medically necessary to initiate or alter therapy with these drugs during the initial 16 week study period, data will not be used in the study. * Metronidazole for single courses of therapy not to exceed 14 days within consecutive 90-day intervals, the first of which begins at the initiation of the study. * Erythropoietin for patients under the relevant Treatment IND. * Symptomatic therapies (such as analgesics, antihistamines, antiemetics, antidiarrheal agents). Allowed but not encouraged: * trimethoprim /sulfamethoxazole (T/S) or other sulfonamides. Patients must have the following: * Screened for other causes of dementia. * Stage 1, 2, or 3 AIDS dementia complex. * Estimated premorbid IQ of at least 70. * Anti-HIV antibody or HIV in blood and/or cerebrospinal fluid. * If prior history of positive syphilis serology, should have been treated with appropriate course of antibiotics; if …

Trial details

NCT IDNCT00000657

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL