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

Primary Purpose

HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatments
Sponsored by
Nova Southeastern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV Infections focused on measuring Human Immunodeficiency Virus (HIV), complementary therapies

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Nova Southeastern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 19, 2008
Last Updated
July 7, 2008
Sponsor
Nova Southeastern University
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1. Study Identification

Unique Protocol Identification Number
NCT00703248
Brief Title
The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study
Acronym
HOME
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nova Southeastern University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Human Immunodeficiency Virus (HIV), complementary therapies

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Osteopathic Manipulative Treatments
Intervention Description
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.

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Nova Southeastern University
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33314
Country
United States

12. IPD Sharing Statement

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The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study

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