An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients

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.