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 @ 3:24 PM
Ignite Modification Date:
2025-12-24 @ 3:24 PM
NCT ID:
NCT00000692
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Aerosolized pentamidine.
* Nystatin.
* Clotrimazole.
* Topical acyclovir.
Concurrent Treatment:
Allowed:
* Blood transfusions for = or \> grade 3 hemoglobin toxicity.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions will be excluded:
* Clinical significant diarrhea (\> 3 stools per day for \> 7 days without definable cause).
* Active opportunistic infection, requiring ongoing therapy, at time of enrollment.
* Any malignancy besides Kaposi's sarcoma, basal cell carcinoma, or squamous cell carcinoma unless the squamous cell carcinoma requires ongoing therapy.
* Neurologic disease including dementia, peripheral neuropathy, myelopathy (CDC category IVb).
Concurrent Medication:
Excluded:
* Antimetabolites.
* Alkylating agents.
* Drugs with known hepatic or bone marrow toxicity.
Patients with significant organ dysfunction will be excluded.
Prior Medication:
Excluded:
* Antimetabolites.
* Alkylating agents.
* Excluded within 30 days of study entry:
* Any investigational medication.
* Drugs with anti-HIV activity.
* Excluded within 90 days of study entry:
* Ribavirin treatment.
* Excluded within 6 months of study entry:
* Cancer chemotherapy.
Prior Treatment:
Excluded within 6 months of study entry:
* Radiation therapy.
Patients must demonstrate the following clinical and laboratory findings:
* AIDS or advanced AIDS related complex (ARC), according to Centers for Disease Control (CDC) category IV, excluding neurologic disease in IVb.
* Ability to understand the terms of study participation.
Current use of illicit drugs or abuse of alcohol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00000692
Study Brief:
Protocol Section:
NCT00000692