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:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-25 @ 4:54 AM
NCT ID:
NCT00002018
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Zidovudine (AZT).
* Didanosine (ddI)
Patients must have:
* Seropositivity to HIV-1 by ELISA and Western blot.
* At least 1 of the HIV-related clinical symptoms or opportunistic infections listed in protocol.
* Written informed consent.
* If already on zidovudine (AZT) or didanosine (ddI), must have been on this therapy for at least 75 of the 90 days prior to study entry.
Prior Medication:
Allowed:
* Zidovudine (AZT).
* Didanosine (ddI)
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
* Major active opportunistic infection requiring active care within 2 weeks of study entry.
* Evidence of chronic hepatitis with severe liver dysfunction:
* albumin \< 2 g/dl and SGOT or SGPT \> 5 x upper limit of normal prothrombin time \> 1.5 x upper limit of normal).
* Other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurologic, or psychiatric disorder.
* Transfusion dependency defined as requiring \> 1 unit of packed red blood cells (RBC) per month within 3 months prior to study entry.
Concurrent Medication:
Excluded:
* Experimental medications other than didanosine (ddI).
* Chronic prophylactic use of any topical or systemic fungal medication such as ketoconazole, fluconazole, or clotrimazole.
* Chronic prophylactic use of any topical or systemic anti-viral medication such as acyclovir or ganciclovir except zidovudine (AZT) or didanosine (ddI).
Patients with the following are excluded:
* Asymptomatic at study entry.
* Presence of antibodies to interferon due to prior therapy.
* Hospitalization within 2 weeks of study entry.
* Transfusion dependency.
* Unwilling or unable to give informed consent.
* Evidence of any concurrent organ dysfunction listed in Exclusion Co-Existing Conditions.
* Unlikely or unable to comply with the requirements of the protocol.
Prior Medication:
Excluded within 6 weeks of study entry:
* Interferons.
* Excluded within 45 days of study entry:
* Immunosuppressive agents.
* Chemotherapy.
* Steroids.
* Immunomodulators.
* Isoprinosine.
* BCG vaccine.
Prior Treatment:
Excluded within 2 weeks of study entry:
* Hospitalization.
Active intravenous (IV) drug abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00002018
Study Brief:
Protocol Section:
NCT00002018