The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study (HOME)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
HIV Infections	Procedure: Osteopathic Manipulative Treatments	Not Applicable

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1	Procedure: Osteopathic Manipulative Treatments; 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.
No Intervention: 2

Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Florida
Nova Southeastern University
Fort Lauderdale, Florida, United States, 33314

Sponsors and Collaborators

Nova Southeastern University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mark A Newberry
ClinicalTrials.gov Identifier:	NCT00703248 History of Changes
Other Study ID Numbers:	HPD-OST10030701
First Posted:	June 23, 2008
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