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


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

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