Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Wyeth is now a wholly owned subsidiary of Pfizer
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Concurrent Medication:
Allowed:
Standard therapy for infections.
Acyclovir.
Ganciclovir.
Allowed only with permission of Wyeth-Ayerst medical monitor:
Zidovudine (AZT).
Immunomodulators.
Specific therapy for malignancies (including Kaposi's sarcoma).
You may not be if
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Evidence of severe liver dysfunction (serum albumin \< 3 g/dl, SGOT or SGPT \> 5 x upper limit of normal, prothrombin time \> 15 seconds), or gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular system abnormalities or psychiatric disorder other than abnormalities secondary to AIDS or AIDS related complex (ARC).
Evidence of AIDS-related central nervous system involvement.
Disseminated Kaposi's sarcoma.
Concurrent Medication:
Excluded without permission of Wyeth-Ayerst medical monitor:
Zidovudine (AZT).
Immunomodulators.
Specific therapy for malignancies (including Kaposi's sarcoma).
Patients with the following are excluded:
Evidence of major system abnormalities other than abnormalities secondary to AIDS or AIDS related complex.
Concomitant conditions as specified in Patient Exclusion Co-existing Conditions.
Unlikely or unable to comply with the requirements of the protocol.
Prior Medication:
Excluded within 4 weeks of study entry:
Systemic antiviral agents.
Immunosuppressive agents.
Immune stimulators such as BCG vaccine, isoprinosine, or other immunomodulators.
Patients must:
Have a diagnosis of AIDS or AIDS related complex (ARC).
Demonstrate intolerance or refusal to take zidovudine (AZT).
Provide written informed consent.
Clareo Health | An Open Parallel Study to Determine the Optimum Dosing Schedule for AS-101 in AIDS/ARC Patients