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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT00000756
Eligibility Criteria:
Inclusion Criteria
Concurrent Medication:
Allowed:
* Approved antiretroviral therapy and/or prophylactic PCP therapy, provided there was no change in such therapy in the 4 weeks prior to study entry.
* Other approved treatments for HIV-related diseases that are not known to affect cellular immune response.
* G-CSF.
* Erythropoietin.
* Supportive care for acute therapy-related toxicity.
Patients must have:
* HIV infection.
* CD4 count 100 - 400 cells/mm3.
* No current or previously documented AIDS-related opportunistic infection, malignancy, or encephalopathy other than mild Kaposi's sarcoma.
* FEV1 \> 70 percent, DLCO \> 50 percent predicted for height and age (initial infusion only).
* T cell lines with specific cytotoxicity against HIV-1.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* Significant autoimmune disease.
* Non-AIDS-associated malignancy.
* Symptoms of cardiac disease.
* Dyspnea on significant exertion.
* Acute infiltrates on chest radiographs.
Patients with the following prior conditions are excluded:
* History of significant arrhythmia, infarction, or heart failure.
* History of a major psychiatric illness.
Prior Medication:
Excluded within 4 weeks prior to study entry:
* Systemic immunosuppressive therapy (i.e., steroids, cyclosporine, chemotherapy, or alpha-interferon).
* Therapy for acute infection, AIDS-related opportunistic infection, or malignancy.
* Experimental AIDS therapy.
Prior Treatment:
Excluded:
* Potentially immunosuppressive local therapy or radiation therapy for Kaposi's sarcoma within 4 weeks prior to study entry.
Current substance abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00000756
Study Brief:
Protocol Section:
NCT00000756