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

Wyeth

Status: Completed

Conditions: HIV Infections

Treatments: Drug: AS-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002266

753A-103-US

045B

Details and patient eligibility

About

To compare AS-101 dosing schedules (once a week; 3 times a week; 5 times a week; or 5 times per week on alternate weeks) on the effect on clinical immunology and virus burden in AIDS or AIDS related complex (ARC) patients.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.