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).
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.
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)
