RHIV A Pilot Study Refractory or Intolerant to Highly Active Antiretroviral Therapy (HAART)

NCT00157027 | Withdrawn Phase 1 DMC

• 1 other identifier: R03-05-012
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 the effects of this therapy on HIV-1 viral load by polymerase chain reaction (PCR) analysis;
• Evaluate the effects of this therapy on CD4+, CD8+ cells and CD4/CD8 ratio;
• Evaluate the effects of this therapy on the patient's immune system, by skin reactivity to a standard anergy panel.

Conditions

HIV Infections

Keywords

Treatment Experienced; HIV-1 Positive by ELISA Assay; Confirmed by Western Blot; Refractory or intolerant to HAART

Outcome Measures

Primary Outcomes (4)

• evaluate the effects of this therapy on HIV-1 viral load by PCR analysis

  9 months

• evaluate the effects of this therapy on CD4+, CD8+ cells and CD4/CD8 ratio

  9 months

• evaluate the effects of this therapy on the patient's immune system, by skin reactivity to a standard anergy panel

  9 months

• 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.

  9 months

Study Arms (1)

1

ACTIVE COMPARATOR

Photopheresis (or extracorporeal photoimmunetherapy \[ECP\]) is a process developed by THERAKOS, Inc., a Johnson and Johnson Company. During the process of ECP, whole blood is drawn from the patient over several cycles, centrifuged and separated into the components of plasma, white cells (or buffy coat), and red blood cells. A portion of the white cells and the plasma are saved in a separate compartment. The remaining plasma and red blood cells are immediately returned to the patient. The saved buffy coat (white blood cells) and plasma are inoculated with the photosensitizing agent UVADEX. Photoactivation begins when the suspension is exposed to a prescribed amount of ultraviolet-A light. After photoactivation is complete, the treated suspension is returned to the patient.

Procedure: Extracorporeal photochemotherapy with UVADEX

Interventions

Extracorporeal photochemotherapy with UVADEX PROCEDURE

Photopheresis (or extracorporeal photoimmunetherapy \[ECP\]) is a process developed by THERAKOS, Inc., a Johnson and Johnson Company. During the process of ECP, whole blood is drawn from the patient over several cycles, centrifuged and separated into the components of plasma, white cells (or buffy coat), and red blood cells. A portion of the white cells and the plasma are saved in a separate compartment. The remaining plasma and red blood cells are immediately returned to the patient. The saved buffy coat (white blood cells) and plasma are inoculated with the photosensitizing agent UVADEX. Photoactivation begins when the suspension is exposed to a prescribed amount of ultraviolet-A light. After photoactivation is complete, the treated suspension is returned to the patient.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Established history of heparin or psoralen allergy
• 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.

Sponsors & Collaborators

• Atlantic Health System: lead
• Therakos: collaborator

MeSH Terms

Conditions

HIV Infections

Interventions

Photopheresis; Methoxsalen

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

PUVA Therapy; Ultraviolet Therapy; Phototherapy; Therapeutics; Extracorporeal Circulation; Surgical Procedures, Operative; Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Emil Bisaccia, MD

  Morristown Memorial Hospital-Atlantic Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: December 1, 2003
• Study Completion: April 1, 2010
• Last Updated: January 16, 2014

Record last verified: 2014-01