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Safety Study of the HemoModulator System for the Treatment of Patients With Human Immunodeficiency Virus (HIV) | Clinical Trials | Clareo Health

UNKNOWNPHASE1

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

Phase 1 Study of the HemoModulator System for the Treatment of Human Immunodeficiency Virus (HIV)

NCT00858923•Energex Systems, Inc.

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - 70 years

Sex

ALL

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
+1 more criteria

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
+4 more criteria

Locations (1)

Tulane University Health Sciences Center/LaCarp

New Orleans, Louisiana, United States

Key Dates

Start Date

July 1, 2008

Primary Completion Date

July 1, 2009

Completion Date

November 1, 2009

Last Updated

April 8, 2009

Enrollment

ACTUAL participants

Conditions

HIVHIV Infections

Interventions

Energex HemoModulator

DEVICE

Thinking and Memory Problems in People With HIV

NCT01875588

HIV Positive

View study

RECRUITINGPHASE3

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

NCT07071623

Human Immunodeficiency Virus (HIV)HIV Pre-Exposure Prophylaxis

View study

RECRUITINGPHASE2

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Thinking and Memory Problems in People With HIV

A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010)

Therapy Adapted for High Risk and Low Risk HIV-Associated Anal Cancer

Long-acting Cabotegravir Injectable Pre-exposure Prophylaxis for People Who Inject Drugs

The LD Lync Study - Natural History Study of Lipodystrophy Syndromes

Imaging and Biopsy of People With HIV-1 Undergoing Analytic Treatment Interruption