The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study (HOME)
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ClinicalTrials.gov Identifier: NCT00703248 |
Recruitment Status
:
Completed
First Posted
: June 23, 2008
Last Update Posted
: July 8, 2008
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections | Procedure: Osteopathic Manipulative Treatments | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Supportive Care |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Procedure: Osteopathic Manipulative Treatments
|
No Intervention: 2 |

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00703248
United States, Florida | |
Nova Southeastern University | |
Fort Lauderdale, Florida, United States, 33314 |
Responsible Party: | Mark A Newberry |
ClinicalTrials.gov Identifier: | NCT00703248 History of Changes |
Other Study ID Numbers: |
HPD-OST10030701 |
First Posted: | June 23, 2008 Key Record Dates |
Last Update Posted: | July 8, 2008 |
Last Verified: | June 2008 |
Keywords provided by Nova Southeastern University:
Human Immunodeficiency Virus (HIV) complementary therapies |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |