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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 March 15, 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.
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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.
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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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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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