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The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study (HOME)
This study has been completed.
Sponsored by: Nova Southeastern University
Information provided by: Nova Southeastern University
ClinicalTrials.gov Identifier: NCT00703248
  Purpose

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 Intervention
HIV Infections
Procedure: Osteopathic Manipulative Treatments

MedlinePlus related topics: AIDS
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care

Further study details as provided by Nova Southeastern University:

Study Start Date: October 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Procedure: Osteopathic Manipulative Treatments
  1. 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.
2: No Intervention

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00703248

Locations
United States, Florida
Nova Southeastern University
Fort Lauderdale, Florida, United States, 33314
Sponsors and Collaborators
Nova Southeastern University
  More Information

Responsible Party: ( Mark A Newberry )
Study ID Numbers: HPD-OST10030701
Study First Received: June 19, 2008
Last Updated: July 7, 2008
ClinicalTrials.gov Identifier: NCT00703248  
Health Authority: United States: Institutional Review Board

Keywords provided by Nova Southeastern University:
Human Immunodeficiency Virus (HIV)
complementary therapies

Study placed in the following topic categories:
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009