Comparison of ddI Versus Zidovudine in HIV-Infected Patients

Inclusion Criteria

• •Concurrent Medication:
• •Required:
• •Aerosolized pentamidine (300 mg every 4 weeks using a Respirgard II nebulizer). In the event of physiological intolerance, alternative prophylaxis may be: Trimethoprim / sulfamethoxazole 1 DS tab per day or dapsone 50 - 100 mg/day.
• •Allowed:
• •Maintenance therapy for active AIDS defining opportunistic infections for patients with 9 to 47 weeks' experience with zidovudine (AZT).
• •Treatment of opportunistic infections with other than sulfonamide containing drugs:
• •Pyrimethamine and sulfadiazine or clindamycin for suppression of toxoplasmosis acquired after study entry; fluconazole or amphotericin B for suppression of cryptococcosis or ketoconazole for candidiasis.
• •Intravenous acyclovir for up to 10 days. Erythropoietin for patients under the relevant treatment IND. Analgesics, antihistamines, antiemetics, antidiarrheal agents for symptomatic therapy for toxicities.
• •Isoniazid (INH) if no other acceptable therapy is available.
• •Metronidazole may be used for single courses of therapy not to exceed 14 days within consecutive 90 day intervals. Note:
• •Ketoconazole and dapsone should be taken 2 hours before or 2 hours after taking ddI (amendment 5/20/91).
• •Concurrent Treatment:
• •Allowed:
• •Blood transfusions for hemoglobin toxicity.
• •Patients must:
• •Have a diagnosis of AIDS or advanced AIDS related complex (ARC), or per 8/09/90 amendment, asymptomatic HIV infection with CD4 count = or \< 200 cells/mm3.
• •Be either naive to zidovudine (AZT) or have taken AZT for = or \< 48 weeks.
• •Have ended treatment for acute Pneumocystis carinii pneumonia (PCP) at least 2 weeks before study entry. For patients with 2 months or less experience with AZT, PCP infection will be the single and only AIDS-defining infection and must have been within 120 days of study entry. Per amendment, other AIDS-defining conditions are allowed in the 8 weeks prior to study entry (for patients in the AZT stratum).Only one episode of PCP is permitted unless patient has \> 2 months AZT experience in which case \> 1 prior episode of PCP infection is allowed.
• •Not have experienced a major intolerance to AZT at doses of at least 500 mg if the patient was on AZT therapy for = or \< 48 weeks. A major intolerance is defined as recurrent grade 3 or greater toxicity which results in discontinuation of drug.
• •Allowed:
• •Basal cell carcinoma.
• •In situ carcinoma of the cervix.
• •Occasional premature atrial or ventricular contraction.
• •Patients developing new opportunistic infections after study entry will remain on this protocol.
• •Patients whose AIDS-defining condition is Kaposi's sarcoma alone must have CD4 cell counts \< 300 cells/mm3.
• •Prior Medication:
• •Allowed:
• •Previous treatment with zidovudine (AZT) up to 48 weeks.