HIV InfectionsPhase 1NCT00574522
Energy Specific Far Infrared Radiation Treatment for AIDS
A Phase 1 study testing Far infrared in people with HIV Infections, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
Trial summary
The investigators are proposing that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby enhancing the production of killer cells to fight and destroy the human immunodeficiency virus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections
- What is being tested?
- Far infrared
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Feb 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1 Year and above
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for HIV/AIDS
The investigators are proposing that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby enhancing the production of killer cells to fight and destroy the human immunodeficiency virus.
Read the detailed description
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome (AIDS or Aids) is a collection of symptoms and infections resulting from the specific damage to the immune system caused by the human immunodeficiency virus (HIV) in humans. The late stage of the condition leaves individuals prone to opportunistic infections and tumors. Although treatments for AIDS and HIV exist to slow the virus' progression, there is no known cure.
The investigators are postulating that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby enhancing the production of CD4+ T cells and other killer cells to fight and destroy the human immunodeficiency virus.
The primary end point is to determine the therapeutic effects of far infrared radiation (5μm to 20μm wavelength) on HIV/AIDS.
- Conditions
- HIV Infections
- Being tested
- Far infrared
- Keywords
- HIV, AIDS, Radiation, Far infrared, Treatment, Acquired Immunodeficiency Syndrome, Complimentary therapies
- Medical subject headings
- HIV Infections, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Far infraredRadiation
Far infrared radiation with the wavelength between 5μm and 20μm for 30 to 40 minutes per session.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Infrared Radiation, wavelength between 5 and 20 microns Receives: Radiation: Far infrared |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is to determine the therapeutic effects of far infrared radiation (5μm to 15μm wavelength) on HIV/AIDS.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startFeb 2008
- Primary completionAug 2009
- 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 HIV InfectionsStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- GAAD Medical Research Institute Inc.
- Sponsor type
- University, hospital or other
- Investigators
- Ken Nedd, M.D., Principal investigator, GAAD Medical Research Institute Inc.Kwasi Donyina, Ph.D., Study director, GAAD Medical Research Institute Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574522
- Sponsor's protocol ID
- GAAD-HIV-CTP1
- Status last verified
- Aug 2009
- First submitted
- 12 Dec 2007
- Last updated
- 17 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for HIV/AIDS
- ClinicalTrials.gov ID
- NCT00574522
- Acronym / sponsor ID
- GAAD-HIV-CTP1
- Conditions
- HIV Infections
- Keywords
- HIV, AIDS, Radiation, Far infrared, Treatment, Acquired Immunodeficiency Syndrome, Complimentary therapies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GAAD Medical Research Institute Inc.University, hospital or other
- Study start
- Feb 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Nov 2009 (estimated)
- First posted
- 17 Dec 2007 (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.
The investigators are proposing that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby enhancing the production of killer cells to fight and destroy the human immunodeficiency virus.
Detailed description
Acquired immune deficiency syndrome or acquired immunodeficiency syndrome (AIDS or Aids) is a collection of symptoms and infections resulting from the specific damage to the immune system caused by the human immunodeficiency virus (HIV) in humans. The late stage of the condition leaves individuals prone to opportunistic infections and tumors. Although treatments for AIDS and HIV exist to slow the virus' progression, there is no known cure.
The investigators are postulating that energy specific electromagnetic radiation of the central nervous system, the viscera and the endocrine system has the potential to enhance the immune system; thereby enhancing the production of CD4+ T cells and other killer cells to fight and destroy the human immunodeficiency virus.
The primary end point is to determine the therapeutic effects of far infrared radiation (5μm to 20μm wavelength) on HIV/AIDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Radiation: Far infraredInfrared Radiation, wavelength between 5 and 20 microns |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1 Year and above
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Far infraredFar infrared radiation with the wavelength between 5μm and 20μm for 30 to 40 minutes per session. | Radiation | 1 |
Primary outcome
The primary end point is to determine the therapeutic effects of far infrared radiation (5μm to 15μm wavelength) on HIV/AIDS.
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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.
Ken Nedd, M.D. principal investigator
GAAD Medical Research Institute Inc.
Kwasi Donyina, Ph.D. study director
GAAD Medical Research Institute Inc.
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 Far infrared in people with HIV Infections, run by GAAD Medical Research Institute Inc. at 1 site in Canada.
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 1 inclusion and 1 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 17 Aug 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 Canada. 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?
The primary end point is to determine the therapeutic effects of far infrared radiation (5μm to 15μm wavelength) on HIV/AIDS. (time frame: One year). 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 17 Aug 2009.