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

Last updated on March 14, 2019

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Study Location
Univ of Arizona / Health Science Ctr
Tucson, Arizona, 85724 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

- Evidence of severe liver dysfunction (serum albumin 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.

NCT00002266
Pfizer
Completed
An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients

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[email protected]

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