Safety Study of the HemoModulator System for the Treatment of Patients With Human Immunodeficiency Virus (HIV)
Primary Purpose
HIV, HIV Infections
Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Energex HemoModulator
Sponsored by
About this trial
This is an interventional treatment trial for HIV focused on measuring Extracorporeal Photophoresis, immuno-therapy, treatment naive
Eligibility 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
Sites / Locations
- Tulane University Health Sciences Center/LaCarp
Outcomes
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00858923
Brief Title
Safety Study of the HemoModulator System for the Treatment of Patients With Human Immunodeficiency Virus (HIV)
Official Title
Phase 1 Study of the HemoModulator System for the Treatment of Human Immunodeficiency Virus (HIV)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
November 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Energex Systems, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, HIV Infections
Keywords
Extracorporeal Photophoresis, immuno-therapy, treatment naive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Energex HemoModulator
Other Intervention Name(s)
Extracorporeal photophoresis
Intervention Description
To use ultraviolet light to reduce HIV virus in the patient's blood
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tulane University Health Sciences Center/LaCarp
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
12. IPD Sharing Statement
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Safety Study of the HemoModulator System for the Treatment of Patients With Human Immunodeficiency Virus (HIV)
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