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

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
HIV Infections	Drug: Zidovudine; Drug: AS-101	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Primary Purpose:	Treatment
Official Title:	A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years to 60 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

United States, California
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 900331084

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

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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)

ClinicalTrials.gov Identifier:	NCT00002013 History of Changes
Other Study ID Numbers:	045C; 753A-109-US
First Posted:	August 31, 2001
Last Update Posted:	June 24, 2005
Last Verified:	December 1990

Keywords provided by NIH AIDS Clinical Trials Information Service:

Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; ammonium trichloro(dioxoethylene-O,O'-)tellurute; Zidovudine

Additional relevant MeSH terms:

HIV Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Zidovudine; Ammonium trichloro(dioxoethylene-O,O'-)tellurate; Antimetabolites; Molecular Mechanisms of Pharmacological Action	Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Anti-HIV Agents; Adjuvants, Immunologic; Immunologic Factors; Physiological Effects of Drugs; Antineoplastic Agents; Radiation-Protective Agents; Protective Agents