Inclusion Criteria
Concurrent Medication:
Allowed:
- Standard therapy for infections.
- Acyclovir.
- Ganciclovir.
- Allowed only with permission of Wyeth-Ayerst medical monitor:
- Zidovudine (AZT).
- Immunomodulators.
- Specific therapy for malignancies (including Kaposi's sarcoma).
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
- Evidence of severe liver dysfunction (serum albumin < 3 g/dl, SGOT or SGPT > 5 x upper limit of normal, prothrombin time > 15 seconds), or gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorder other than abnormalities secondary to AIDS or AIDS related complex (ARC).
- Evidence of AIDS-related central nervous system involvement.
- Disseminated Kaposi's sarcoma.
Concurrent Medication:
Excluded without permission of Wyeth-Ayerst medical monitor:
- Zidovudine (AZT).
- Immunomodulators.
- Specific therapy for malignancies (including Kaposi's sarcoma).
Patients with the following are excluded:
- Evidence of major system abnormalities other than abnormalities secondary to AIDS or AIDS related complex.
- Concomitant conditions as specified in Patient Exclusion Co-existing Conditions.
- Unlikely or unable to comply with the requirements of the protocol.
Prior Medication:
Excluded within 4 weeks of study entry:
- Systemic antiviral agents.
- Immunosuppressive agents.
- Immune stimulators such as BCG vaccine, isoprinosine, or other immunomodulators.
Patients must:
- Have a diagnosis of AIDS or AIDS related complex (ARC).
- Demonstrate intolerance or refusal to take zidovudine (AZT).
- Provide written informed consent.