Search / Trial NCT00002266

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

Launched by WYETH IS NOW A WHOLLY OWNED SUBSIDIARY OF PFIZER · Aug 30, 2001

Trial Information

Current as of December 07, 2024

Completed

Keywords

Drug Therapy, Combination Acquired Immunodeficiency Syndrome Aids Related Complex Ammonium Trichloro(dioxoethylene O,O' )Tellurute

ClinConnect Summary

No description provided

Gender

ALL

Eligibility 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.

About Wyeth Is Now A Wholly Owned Subsidiary Of Pfizer

Wyeth, now a wholly owned subsidiary of Pfizer, is a global biopharmaceutical company dedicated to advancing healthcare through innovative research and development. With a strong legacy in the pharmaceutical industry, Wyeth focuses on discovering and delivering medicines that address significant medical needs across various therapeutic areas, including vaccines, biologics, and specialty pharmaceuticals. Leveraging Pfizer's extensive resources and expertise, Wyeth continues to drive scientific advancement and improve patient outcomes worldwide.

Locations

Tucson, Arizona, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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