HIVPhase 1NCT00858923
Safety Study of the HemoModulator System for the Treatment of Patients With Human Immunodeficiency Virus (HIV)
A Phase 1 study testing Energex HemoModulator in people with HIV and HIV Infections, run by Energex Systems, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV, HIV Infections
- What is being tested?
- Energex HemoModulator
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Nov 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Tulane University Health Sciences Center/LaCarp
New Orleans, Louisiana, 70112
About this study
Official title: Phase 1 Study of the HemoModulator System for the Treatment of Human Immunodeficiency Virus (HIV)
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.
Read the 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)
- Conditions
- HIV, HIV Infections
- Being tested
- Energex HemoModulator
- Keywords
- Extracorporeal Photophoresis, immuno-therapy, treatment naive
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energex HemoModulatorDevice
Also called Extracorporeal photophoresis
To use ultraviolet light to reduce HIV virus in the patient's blood
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Once a week for 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startJul 2008
- Primary completionJul 2009 (estimated)
- Study completionNov 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Energex Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00858923
- Sponsor's protocol ID
- G080104
- Status last verified
- Mar 2009
- First submitted
- 6 Mar 2009
- Last updated
- 8 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of the HemoModulator System for the Treatment of Human Immunodeficiency Virus (HIV)
- ClinicalTrials.gov ID
- NCT00858923
- Acronym / sponsor ID
- G080104
- Conditions
- HIV, HIV Infections
- Keywords
- Extracorporeal Photophoresis, immuno-therapy, treatment naive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Energex Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Nov 2009 (estimated)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Subject has a CD4+ count ≥ 400 cells/mm3
- Subject's pre-screen EIA and RIBA test has proven negative for Hepatitis C virus
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energex HemoModulatorAlso: Extracorporeal photophoresisTo use ultraviolet light to reduce HIV virus in the patient's blood | Device | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Energex HemoModulator in people with HIV and HIV Infections, run by Energex Systems, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2009.