The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study

HIV Infections Clinical Trial

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Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703248
• Other study ID #: HPD-OST10030701
• Status: Completed
• Phase: N/A
• First received: June 19, 2008
• Last updated: July 7, 2008
• Start date: October 2007
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Nova Southeastern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections

Intervention

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.

Locations

Country	Name	City	State
United States	Nova Southeastern University	Fort Lauderdale	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nova Southeastern University

Country where clinical trial is conducted

United States,