You are here

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

Last updated on October 13, 2019

FOR MORE INFORMATION
Study Location
Los Angeles County - USC Med Ctr
Los Angeles, California, 900331084 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00002013
Pfizer
Completed
A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
Official Title  ICMJE A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
Brief SummaryTo 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).
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Drug: Zidovudine
  • Drug: AS-101
Study Arms  ICMJE Not Provided
Publications *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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE Not Provided
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002013
Other Study ID Numbers  ICMJE 045C
753A-109-US
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyNot Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS AccountNIH AIDS Clinical Trials Information Service
Verification DateDecember 1990

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]m

Call Now