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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002013
• Other study ID #: 045C
• Secondary ID: 753A-109-US
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: December 1990
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• Zidovudine

• AS-101

Locations

Country	Name	City	State
United States	Los Angeles County - USC Med Ctr	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

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)