Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-24 @ 4:05 PM
NCT ID:
NCT00002266
Eligibility Criteria:
Inclusion Criteria
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).
Exclusion Criteria
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00002266
Study Brief:
Protocol Section:
NCT00002266