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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT00157027
Eligibility Criteria:
Inclusion Criteria:
* HIV-1 positive by ELISA assay and confirmed by Western blot
* Patients must be refractory or intolerant to HAART. Refractory HIV patients are defined as those patients meeting the following criteria:
* Resistance to all major groups of active agents (non-nucleotide reverse transcriptase inhibitors \[NNRTIs\], nucleotide reverse transcriptase inhibitors \[NRTIs\], and protease inhibitors \[PIs\]);
* Not achieving \< 400 copies/mL by 24 weeks or \< 50 copies/mL by 48 weeks of therapy; or
* Documentation of resistance mutations by genotype testing; or
* Failure to increase CD4+ cells \> 25 cells/mm3 above baseline after one year of therapy.
* HIV RNA \>= 3,000 copies/mL by PCR analysis
* CD4 count \> 75 cells/mm3
* No new antiretroviral agents may be added during the pre-study evaluation, treatment, or follow-up periods.
* Life expectancy \> 6 months
* Able to give informed consent and comply with all study visits, procedures, and the ECP treatment schedule
* Ages between 18 and 70
* Females of childbearing potential may not be lactating and must be human chorionic gonadotropin (HCG) negative at study entry and agree to use acceptable methods of birth control (hormonal, intrauterine device, and spermicide and barrier) throughout the study period.
* Minimum body weight of 88 lbs (40kg)
* May not have current photosensitive diseases such as systemic lupus erythematosus (SLE) or porphyria
* Adequate hematological function with an absolute neutrophil count of \>= 500/mm and a platelet count of \>= 50,000/mm.
Exclusion Criteria:
* Established history of heparin or psoralen allergy
* Patients with aphakia because of significantly increased risk of retinal damage due to absence of lenses. Patients with lens implants are acceptable for inclusion.
* Current participation (within 30 days) in a clinical trial examining the safety and/or efficacy of anti-retroviral agent(s)
* Patients with any other major illness (e.g. malignancy, renal failure, severe cardiac disease, severe neurologic disease) that either might preclude completion of the study or bias efficacy assessments.
* Patients who cannot or may not tolerate the extracorporeal volume required during the procedure, for reasons such as severe cardiovascular disease, i.e. history of congestive heart failure or severe anemia (hemoglobin \< 90 g/L)
* Patients with a photosensitive disease, such as porphyria or systemic lupus erythematosus. Special care must be taken in the treatment of patients who require medications (either topically or systemically) during the course of the study with photosensitizing potential, such as phenothiazine, tetracyclines, sulfonamides, some non-steroidal anti-inflammatory drugs (NSAIDs) or chlorothiazide. Patients who must take photosensitizing drugs during the study will not receive them within 24 hours of each scheduled treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00157027
Study Brief:
Protocol Section:
NCT00157027