Inclusion Criteria
Concurrent Medication:
Allowed:
- Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
- Up to 14 days of systemic therapy for minor opportunistic infections such as candidiasis, mucocutaneous Herpes simplex or cutaneous Herpes zoster infections.
Patients must have the following:
- AIDS or AIDS related complex (ARC) as defined by the CDC.
- Positive antibody to HIV as determined by a commercially licensed ELISA test kit, confirmed by Western blot analysis.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Symptomatic visceral Kaposi's sarcoma or progression of Kaposi's sarcoma within the month prior to study entry (progression is defined as more than a 25 percent increase in the product of bidirectional measurement of indicator lesions and/or more than a 25 percent increase in the number of new lesions).
- Concurrent neoplasms other than Kaposi's sarcoma or basal cell carcinoma of the skin. Patients who have had a malignancy in the past that has been in complete remission for 1 year without therapy may be enrolled.
- Signs or symptoms of neuropathy and a Vibratron 2 score = or > 4 for either great toe.
Concurrent Medication:
Excluded:
- Acute therapy for AIDS-related infection.
- Systemic maintenance therapy for AIDS-defining opportunistic infection.
- Recombinant erythropoietin.
- Long term therapy with either aspirin or probenecid.
Concurrent Treatment:
Excluded:
- Blood transfusion more than once per month.
Patients with the following are excluded:
- Symptomatic visceral Kaposi's sarcoma or progression of Kaposi's sarcoma within the month prior to study entry.
- Unwilling to sign an informed consent or patients unwilling to be followed at the medical center where they were enrolled for the duration of the study and follow-up as required.
- History of intolerance to zidovudine (AZT) at any dose as demonstrated by an AZT related decrease in hemoglobin levels of at least 2 g/dl or AZT related depression of neutrophils of at least 200 cells/mm3 to < 750 cells/mm3 which required discontinuation of AZT therapy.
- Diseases or conditions listed in Exclusion Co-Existing Conditions.
Prior Medication:
Excluded:
- Antiretroviral agents within 14 days of study entry.
- Immunomodulating agents or corticosteroids within 30 days prior to study entry.
- Treatment for acute Pneumocystis carinii pneumonia within 2 weeks prior to study entry.
Prior Treatment:
Excluded:
- Blood transfusions within 7 days prior to study entry.
- Radiation therapy for Kaposi's sarcoma within 30 days prior to study entry.
Active substance abuse.
Purpose
