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

NCT ID: NCT00002013

Last Updated: 2005-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

Brief 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).

Conditions

HIV Infections

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Zidovudine

Intervention Type: DRUG

AS-101

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Locations

Los Angeles County - USC Med Ctr

Los Angeles, California, United States

Countries

United States

References

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)

Reference Type: BACKGROUND

Other Identifiers

753A-109-US

Identifier Type: -

Identifier Source: secondary_id

045C

Identifier Type: -

Identifier Source: org_study_id