The Human Immunodeficiency Virus and Osteopathic Manipulation Evaluation Study

Not Applicable

Completed

• Conditions: HIV Infections
• Interventions: Procedure: Osteopathic Manipulative Treatments

• Registration Number: NCT00703248
• Lead Sponsor: Nova Southeastern University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Status Verified: 2008-06
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-20
• Study First Posted: 2008-06-23
• Last Update Submitted: 2008-07-07
• Last Update Posted: 2008-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

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

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Osteopathic Manipulative Treatments	-

Trial Locations

Locations (1)

Nova Southeastern University; 🇺🇸 Fort Lauderdale, Florida, United States