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.