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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: June 24, 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
  Purpose
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.

Condition Intervention
HIV Infections Drug: AS-101

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002266


Locations
United States, Arizona
Univ of Arizona / Health Science Ctr
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

ClinicalTrials.gov Identifier: NCT00002266     History of Changes
Other Study ID Numbers: 045B
753A-103-US
First Submitted: November 2, 1999
First Posted: August 31, 2001
Last Update Posted: June 24, 2005
Last Verified: December 1990

Keywords provided by NIH AIDS Clinical Trials Information Service:
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
ammonium trichloro(dioxoethylene-O,O'-)tellurute

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Ammonium trichloro(dioxoethylene-O,O'-)tellurate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Radiation-Protective Agents
Protective Agents