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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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AS-101

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Univ of Arizona / Health Science Ctr

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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753A-103-US

Identifier Type: -

Identifier Source: secondary_id

045B