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A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002013
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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A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
To evaluate safety, pharmacokinetics, immunologic parameters and neurocognitive data for three dosages of AS-101 in combination with zidovudine (AZT) in patients with AIDS or AIDS related complex (ARC).
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Interventional
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Primary Purpose: Treatment
HIV Infections
  • Drug: Zidovudine
  • Drug: AS-101
Not Provided
Laporate JP, Frottier J, Dormont D, Imbert JC, Albeck M, Najman A. As 101 in association with azt in AIDS patients: a phase I pilot study. Int Conf AIDS. 1989 Jun 4-9;5:405 (abstract no WBP320)

*   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:

Required:

  • Zidovudine (AZT).
  • Aerosolized pentamidine for Pneumocystis carinii pneumonia (PCP) prophylaxis.
  • Allowed ONLY with permission of the Wyeth-Ayerst medical monitor:
  • Standard therapy for infections that develop during the study period.
  • Oral acyclovir.
  • Nystatin.
  • Ketoconazole.
  • Immunomodulators.
  • Specific therapy for malignancies (including Kaposi's sarcoma).

Patients must have the following:

  • Diagnosis of AIDS or AIDS related complex (ARC).
  • Provide informed written consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Active opportunistic infection or malignancy requiring treatment at study entry.
  • Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
  • Evidence of central nervous system (CNS) opportunistic infection or malignancy.
  • Serious underlying medical problems, including insulin- dependent diabetes mellitus, unstable ASHD (atherosclerotic heart disease) or uncontrolled hypertension, which may complicate interpretation of treatment results.
  • Dementia.
  • Evidence of = or > 2 + proteinuria at study entry.

Concurrent Medication:

Excluded without permission of the Wyeth-Ayerst medical monitor:

  • Immunomodulators.
  • Specific therapy for malignancies (including Kaposi's sarcoma).

Patients with the following are excluded:

  • Active opportunistic infection or malignancy requiring treatment at study entry.
  • Prior history of psychiatric illness or head injury which in the judgment of the neuropsychologist would impair interpretation of the neurocognitive data.
  • Evidence of conditions listed in the Patient Exclusion Co-existing Conditions.
  • Active substance abuse.
  • Unlikely or unable to comply with the requirements of the protocol.

Prior Medication:

Excluded within 8 weeks of study entry:

  • Immunomodulators.
  • Antiviral therapy, except zidovudine.
  • Excluded within 2 weeks of study entry:
  • Intravenous or oral acyclovir.
  • Excluded within 3 months of study entry:
  • Ribavirin.

Required:

  • Zidovudine at a dose of = or > 1000 mg/day for at least 6 weeks prior to study entry.

Active substance abuse.

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
 
 
NCT00002013
045C
753A-109-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