Status:
COMPLETED
The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study
Lead Sponsor:
Nova Southeastern University
Conditions:
HIV Infections
Eligibility:
MALE
18-65 years
Phase:
NA
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. Howeve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
End Date :
June 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00703248
Start Date
October 1 2007
End Date
June 1 2008
Last Update
July 8 2008
Active Locations (1)
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1
Nova Southeastern University
Fort Lauderdale, Florida, United States, 33314