Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Treatments:
Ammonium trichloro(dioxoethylene-O,O'-)tellurate
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.