Status:
WITHDRAWN
RHIV A Pilot Study Refractory or Intolerant to Highly Active Antiretroviral Therapy (HAART)
Lead Sponsor:
Atlantic Health System
Collaborating Sponsors:
Therakos
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objectives of this clinical trial are to: * Assess the safety of using extracorporeal photoimmune therapy with the photosensitizing agent Uvadex in the treatment of HIV-1 infection; * Evaluate th...
Detailed Description
Rationale for the Use of ECP with UVADEX in Patients with HIV-1 Infection Studies have demonstrated that psoralen and ultraviolet A light inactivate HIV virus in vitro. Edelson, et al, showed that ex...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00157027
Start Date
December 1 2003
End Date
April 1 2010
Last Update
January 16 2014
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