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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002266
First Posted: August 31, 2001
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
NIH AIDS Clinical Trials Information Service
November 2, 1999
August 31, 2001
December 9, 2005
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No Changes Posted
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An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients
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.
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Interventional
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Masking: None (Open Label)
Primary Purpose: Treatment
HIV Infections
Drug: AS-101
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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.
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00002266
045B
753A-103-US
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Wyeth is now a wholly owned subsidiary of Pfizer
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NIH AIDS Clinical Trials Information Service
December 1990

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP