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

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ClinicalTrials.gov Identifier: NCT00002013

Recruitment Status : Completed

First Posted : August 31, 2001

Last Update Posted : June 24, 2005

Sponsor:

Information provided by:

NIH AIDS Clinical Trials Information Service

Study Description

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


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Zidovudine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002013

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

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 Key Record Dates
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

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