A Safety, Pilot Pharmacokinetics and Neurocognitive Study of AS-101 in Combination With Zidovudine in AIDS/ARC Patients
Completed · Not applicable
Conditions studied: HIV Infections
In brief
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).
Key facts
- Study ID
- NCT00002013
- Run by
- Wyeth is now a wholly owned subsidiary of Pfizer
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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:
Where it is running
- Los Angeles County - USC Med Ctr — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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