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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.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Wyeth
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002266
  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: Treatment, Open Label
Official Title: An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients

Resource links provided by NLM:

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002266

Locations
United States, Arizona
Univ of Arizona / Health Science Ctr
Tucson, Arizona, United States, 85724
Sponsors and Collaborators
Wyeth
  More Information

No publications provided

Study ID Numbers: 045B, 753A-103-US
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002266     History of Changes
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Radiation-Protective Agents
Immunologic Factors
Acquired Immunodeficiency Syndrome
Adjuvants, Immunologic
AIDS-Related Complex
Antiviral Agents
Immunologic Deficiency Syndromes
Virus Diseases
HIV Infections
Ammonium trichloro(dioxoethylene-O,O'-)tellurate
Sexually Transmitted Diseases
Retroviridae Infections

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

ClinicalTrials.gov processed this record on July 02, 2009