An Oral Dose-Ranging Finding Study in Patients With HIV Disease, CDC Classification Groups IIB, III, and IV-C2

Inclusion Criteria Patients must have HIV reactivity. Patients must belong to one of the following three groups according to the CDC classification: IIB - including only those patients with autoimmune thrombocytopenia (platelet count = or < 100000 platelets/mm3). OR Lymphopenia (lymphocyte count = or < 1000 cells/mm3). OR Helper cell lymphopenia (helper cells < the mean of normals). OR CDC classification III or IV-C2. Patients with = or < involuntary 10 percent weight loss in the last 6 months. ECOG performance status 0 or 1. Weigh 70 kg + or - 15 kg in order to standardize the g/kg dosing. Positive antibody for HIV by an ELISA test kit. If the ELISA is negative, then eligibility will be confirmed by second confirmatory test, i.e., immunoblot. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: AIDS or the CDC classification stage IV except stage IV-C2. HIV antibody negative by immunoblot. Persistent fevers of > 38.5 degrees C. Persistent diarrhea undiagnosed > 1 month. Involuntary weight loss of > 10 percent in the 6 months prior to study entry. ECOG performance status of 2, 3, or 4. Class IV-C2 with prior history of: Multidermal herpes zoster. Oral candidiasis on more than one occasion. Tuberculosis. Concurrent Medication: Excluded: Other antiretroviral agents. Active immunomodulating agents. Any other experimental therapy. Drugs which cause anemia or neutropenia. Drugs which are glucuronidated and may interfere with the metabolism of AZT, i.e., acetaminophen > 5 days. Acyclovir systemically administered > 5 days. Any other experimental agents. Patients with the following are excluded: AIDS or the CDC classification stage IV except stage IV-C2. HIV antibody negative by immunoblot. Persistent fevers of > 38.5 degrees C. Persistent diarrhea undiagnosed > 1 month. Involuntary weight loss of > 10 percent in the 6 months prior to study entry. ECOG performance status of 2, 3, or 4. Class IV-C2 with prior history of: Multidermal herpes zoster. Oral candidiasis on more than one occasion. Tuberculosis. Prior Medication: Excluded within 3 months of study entry: Other antiretroviral agents. Active immunomodulating agents. Excluded within 2 weeks of study entry: Drugs which cause anemia or neutropenia. Drugs which are glucuronidated and may interfere with the metabolism of zidovudine (AZT), i.e., acetaminophen > 5 days. Acyclovir systemically administered > 5 days. Any other experimental agents. Known active drug abuse.