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

This study has been completed.
Sponsor:
Information provided by:
Nova Southeastern University
ClinicalTrials.gov Identifier:
NCT00703248
First received: June 19, 2008
Last updated: July 7, 2008
Last verified: June 2008
History of Changes
  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

Study Type: Interventional
Study Design: Primary Purpose: Supportive Care

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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
Experimental: 1 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.
No Intervention: 2

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

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

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
RNA Virus Infections
 Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on March 03, 2015