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

Energex Systems

Status and phase

Unknown

Phase 1

Conditions

HIV

HIV Infections

Treatments

Device: Energex HemoModulator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00858923

G080104

Details and patient eligibility

About

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.

Full 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)

Enrollment

10 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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