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

Last updated on May 11, 2018

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

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Similar Trials

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).
Not Provided
Interventional
Not Provided
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
Not Provided
Not Provided
Not Provided

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
Not Provided
Not Provided
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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