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

Completed · Not applicable

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00002266

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Univ of Arizona / Health Science Ctr — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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