Safety Study of the HemoModulator System for the Treatment of Patients With Human Immunodeficiency Virus (HIV) - Full Text View

Sponsor:	Energex Systems, Inc.
Information provided by:	Energex Systems, Inc.
ClinicalTrials.gov Identifier:	NCT00858923

Purpose

Tulane University Health Sciences Center/Louisiana Community AIDS Research

Center Program, New Orleans, LA is seeking patients for an HIV study. The

purpose of the study is to test the safety and effectiveness of an

experimental ultra-violet light device designed to reduce virus in your blood.

Condition	Intervention	Phase
HIV HIV Infections	Device: Energex HemoModulator	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase 1 Study of the HemoModulator System for the Treatment of Human Immunodeficiency Virus (HIV)

Resource links provided by NLM:

Genetics Home Reference related topics: complement factor I deficiency

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by Energex Systems, Inc.:

Primary Outcome Measures:

Determine the therapy effectiveness on HIV-1 plasma viral load using PCR analysis Determine the therapy effects on CD4+, CD8+ cells and CD4/CD8 ratio [ Time Frame: Once a week for 10 weeks ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	July 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Intervention Details:

To use ultraviolet light to reduce HIV virus in the patient's blood

Other Name: Extracorporeal photophoresis

Detailed Description:

You may be eligible if:

You have HIV
Your CD4 cell count is or greater than 400
Your viral load is greater than 10,00 copies
You do not yet qualify for standard antiviral therapy (HAART)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of HIV-1 has been confirmed positive by ELISA and by Western Blot
Subject is not yet eligible for HAART
Subject's viral count at pre-baseline measured by RT-PCR is
- 10,000 copies /ml
Subject has a CD4+ count ≥ 400 cells/mm3
Subject's pre-screen EIA and RIBA test has proven negative for Hepatitis C virus
Female subjects with reproductive potential (and any male sexual partners) must agree to use a barrier device with spermicide (e.g., condoms, cervical cap, diaphragm) as the primary form of contraception, in addition to any other methods used, during treatment and until the end of the study to prevent pregnancy
Subject has taken no other anti-viral device or pharmacologic treatments in the 2 months prior to the first scheduled Hemo-Modulator study treatment
Subject agrees not to receive any other anti-viral device or anti-viral pharmacologic treatment (including herbal remedies) throughout the 21-week study period
Subject weighs at least 90 lbs (40.9 kg) at study initiation
Subject agrees to comply with study protocol requirements including all follow up visits through Day 60 of study duration

Exclusion Criteria:

Subjects with any other major illness (e.g., malignancy, renal failure, tuberculosis, porphyria, severe cardiac disease, severe neurological disease, or Hepatitis C) that would prevent completion of the study or bias efficacy assessments
Subjects with any other medical condition that the Investigator believes would make the patient unable to safely tolerate the extracorporeal blood volume required during the procedure [e.g., severe cardiovascular disease, history of congestive heart failure, or severe anemia (hemoglobin < 90 g/L)]
Subject with porphyria cutanea tarda (PCT), since PCT is associated with increased sensitivity to light and skin reactions such redness, pain, swelling and blistering after exposure to ultraviolet light
Subject has clinically abnormal hemotologic or chemistry laboratory values, defined as any parameter for these tests that exceeds Grade 1 (DAIDS Table for Grading the Severity of Adult Adverse Events, December 2004)
Subject has taken a steroid drug (other than Estrogen or Progesterone) within 7 days prior to study enrollment, or may require such medications during the course of study participation
Subject has taken a drug listed as photosensitizing in the Physician's Desk Reference (PDR) within 7 days prior to a Hemo-Modulator Treatment session
Subjects that habitually use excessive alcohol
Subjects that use illicit drugs or have an ongoing drug abuse problem
Subjects that have an acute systemic bacterial infection (septicemia)
Subjects that have been immunized for influenza within 7 days prior to study enrollment or is likely to require such immunization during the course of study participation
Subject is currently participating in another clinical investigation of a medical device, drug or biologic, or has participated in such a study within the 3 months prior to study enrollment
Subject is pregnant or plans on becoming pregnant within the next twelve months; or is lactating
Subject has a clotting deficiency
Subject is allergic to heparin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858923

Locations

United States, Louisiana
Tulane University Health Sciences Center/LaCarp
New Orleans, Louisiana, United States, 70112

Sponsors and Collaborators

Energex Systems, Inc.

More Information

No publications provided

Responsible Party:	David M. Mushatt, MD, Tulane U. Health Sciences Center/Louisiana Community AIDS Research Program
ClinicalTrials.gov Identifier:	NCT00858923 History of Changes
Other Study ID Numbers:	G080104
Study First Received:	March 6, 2009
Last Updated:	April 7, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Energex Systems, Inc.:

Extracorporeal Photophoresis
immuno-therapy
treatment naive

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections

Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012