HIV InfectionsHOMENCT00703248
The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study
A study testing Osteopathic Manipulative Treatments in people with HIV Infections, run by Nova Southeastern University at 1 site in United States.
Trial summary
Treatment options that increase immune function, such as Osteopathic Manipulation Treatment (OMT) lymphatic techniques, may provide improved short or long term performance of the immune system. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Osteopathic Manipulative Treatments
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jun 2008
- Phase
- Interventional
- 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 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are either Antiretroviral Therapy (ART) naïve or not have taken ART for the past 12 months
- are between the ages of 18 to 65
- have a CD4+ T cell count between 200-700cells/mm3
- have viral loads less than 100,000 copies/mL
- do not have any medical condition that limits his ability to participate in this study as defined by his physician (e.g., cancer, blood clotting disorder etc.)
- are willing to provide informed consent
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- are not using any drugs recreationally
- are not on prescribed systemic steroids
- are willing to recruit a friend/partner, aware of the their HIV serostatus, to be trained in OMT techniques and apply it to him daily.
Who cannot join
- history of malignancy excluding both squamous cell carcinoma and basal cell carcinoma of the skin and/or any malignancies fully treated and considered cured by the treating physician for at least 1 year
- aortic aneurism/disease
- vertebral artery disease
- carotid artery stenosis/disease
- abdominal hernias
- portal hypertension
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- cirrhosis
- cervical disc disease currently exhibiting radicular symptomatology (i.e. numbness, burning, muscle weakness, etc)
- infectious mononucleosis in the past 12 weeks,
- pneumothorax
- bone disease
- Participants with a medical access port and/or a noncompliant ribcage will be excluded from the study.
- The potential causes for ribcage noncompliance include:
- congestive obstructive pulmonary disorder (COPD)
- spinal arthritis
- costochondritis
- congestive heart failure (CHF)
- pulmonary edema
- recent trauma to the ribcage
- certain connective tissue disease such as Ankylosing Spondylitis
- There is a risk of abdominal aortic aneurysm (AAA) rupture in participants with AAA and these participants are excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nova Southeastern University
Fort Lauderdale, Florida, 33314
About this study
Treatment options that increase immune function, such as Osteopathic Manipulation Treatment (OMT) lymphatic techniques, may provide improved short or long term performance of the immune system. However, the efficacy of OMT to boost immune function among people living with HIV has not yet been examined in a controlled study. Our experiment is designed to examine the short (45 minutes) term impact of OMT on the white blood cells counts of HIV positive men who are either antiretroviral therapy (ART) naïve or have not taken ART for at least 12 months prior to enrollment in the study.
- Conditions
- HIV Infections
- Being tested
- Osteopathic Manipulative Treatments
- Keywords
- Human Immunodeficiency Virus (HIV), complementary 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.
Osteopathic Manipulative TreatmentsProcedure or surgery
- opening the thoracic inlet
- pectoral traction for 1 minute bilaterally
- rib raising for a total of 4 minutes- 2 minutes on each side of the thoracic spine ]
- thoracic pump at a rate of 60 times per minute for a total of 5 minutes bilaterally
- abdominal pump at a rate of 30 times per minute for a total of 5 minutes bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Osteopathic Manipulative Treatments |
| 2 | No intervention | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionJun 2008
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 N/A
- Primary purpose
- Supportive care
Sponsor and investigators
- Lead sponsor
- Nova Southeastern University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00703248
- Sponsor's protocol ID
- HPD-OST10030701
- Acronym
- HOME
- Status last verified
- Jun 2008
- First submitted
- 19 Jun 2008
- Last updated
- 8 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study
- ClinicalTrials.gov ID
- NCT00703248
- Acronym / sponsor ID
- HOME / HPD-OST10030701
- Conditions
- HIV Infections
- Keywords
- Human Immunodeficiency Virus (HIV), complementary therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Nova Southeastern UniversityUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 23 Jun 2008 (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.
Treatment options that increase immune function, such as Osteopathic Manipulation Treatment (OMT) lymphatic techniques, may provide improved short or long term performance of the immune system. However, the efficacy of OMT to boost immune function among people living with HIV has not yet been examined in a controlled study. Our experiment is designed to examine the short (45 minutes) term impact of OMT on the white blood cells counts of HIV positive men who are either antiretroviral therapy (ART) naïve or have not taken ART for at least 12 months prior to enrollment in the study.
Study design
- Primary purpose
- Supportive care
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Osteopathic Manipulative Treatments |
| 2 | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- are either Antiretroviral Therapy (ART) naïve or not have taken ART for the past 12 months
- are between the ages of 18 to 65
- have a CD4+ T cell count between 200-700cells/mm3
- have viral loads less than 100,000 copies/mL
- do not have any medical condition that limits his ability to participate in this study as defined by his physician (e.g., cancer, blood clotting disorder etc.)
Key exclusion criteria (21 listed)
- history of malignancy excluding both squamous cell carcinoma and basal cell carcinoma of the skin and/or any malignancies fully treated and considered cured by the treating physician for at least 1 year
- aortic aneurism/disease
- vertebral artery disease
- carotid artery stenosis/disease
- abdominal hernias
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 |
|---|---|---|
| Osteopathic Manipulative Treatments1. opening the thoracic inlet 2. pectoral traction for 1 minute bilaterally 3. rib raising for a total of 4 minutes- 2 minutes on each side of the thoracic spine ] 4. thoracic pump at a rate of 60 times per minute for a total of 5 minutes bilaterally 5. abdominal pump at a rate of 30 times per minute for a total of 5 minutes bilaterally. | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2008.
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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 study testing Osteopathic Manipulative Treatments in people with HIV Infections, run by Nova Southeastern University 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 9 inclusion and 21 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: finished, as of the sponsor's last update on 8 Jul 2008. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 Jul 2008.