A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
NCT00002013
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
Adult Trials: 18+ Years
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.
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.
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| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients | ||
| Official Title ICMJE | A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients | ||
| 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). | ||
| Detailed Description | Not Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Not Applicable | ||
| Study Design ICMJE | Primary Purpose: Treatment | ||
| Condition ICMJE | HIV Infections | ||
| Intervention ICMJE |
| ||
| Study Arms ICMJE | Not Provided | ||
| 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) | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Enrollment ICMJE | Not Provided | ||
| Original Enrollment ICMJE | Not Provided | ||
| Study Completion Date ICMJE | Not Provided | ||
| Primary Completion Date | Not Provided | ||
| Eligibility Criteria ICMJE | Inclusion Criteria Concurrent Medication: Required:
Patients must have the following:
Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded:
Concurrent Medication: Excluded without permission of the Wyeth-Ayerst medical monitor:
Patients with the following are excluded:
Prior Medication: Excluded within 8 weeks of study entry:
Required:
Active substance abuse. | ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 18 Years to 60 Years (Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00002013 | ||
| Other Study ID Numbers ICMJE | 045C 753A-109-US | ||
| Has Data Monitoring Committee | Not Provided | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Not Provided | ||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | NIH AIDS Clinical Trials Information Service | ||
| Verification Date | December 1990 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||