Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: Acupuncture; Relaxation Response; sham acupuncture
Intervention description: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks; listening to CDs with verbal instructions of techniques to elicit relaxation response; sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV/AIDS; Alternative Medicine; Complementary Medicine

Summary:

      The aims of the study are to investigate individual, combined and added effects of
      acupuncture and the relaxation response in reducing gastrointestinal symptoms, improving
      medication adherence and quality of life among people living with HIV/AIDS. The study will
      also explore the mechanism of these therapeutic effects of acupuncture and the relaxation
      response.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Confirmed HIV-positive status or AIDS diagnosis

          2. Self report of having at least one of the 6 GI symptoms: diarrhea, loose stools,
             gas/flatulence or bloating, abdominal pain, nausea, or vomiting that have persisted
             for at least 8 weeks.

          3. Being on a stable antiretroviral regimen containing Nucleoside/nucleotide reverse
             transcriptase inhibitors and/or protease inhibitors- for at least 8 weeks.

        Exclusion Criteria:

          1. Incident diagnosis of any of the following conditions within the past month or during
             study period: Pneumocystis carinii pneumonia, Kaposi's sarcoma, Mycobacterium avian
             complex, Cytomegalovirus, Non-Hodgkins lymphoma, Lymphoma or other cancer, Pelvic
             inflammatory disease, AIDS-related dementia, Bacterial or other infection, Diabetes,
             Acute moderate or severe neutropenia, Cryptococcus, Progressive multifocal
             leukoencephalopathy, Idiopathic thrombocytopenic purpura. All of these conditions are
             major opportunistic infections or medical complications that may require
             hospitalization and additional pharmaceutical intervention.

          2. GI diagnoses of irritable bowel syndrome, Crohn's Disease, parasites, any type of
             gastric ulcer or ulcerative colitis or cancer in any part of the gastrointestinal
             system. These are conditions not related to HIV diagnosis and could result in
             digestive problems similar to those we are investigating.

          3. Onset of acute opportunistic infection.

          4. Hemophilia or other bleeding disorder since that will make acupuncture treatment
             unsafe.

          5. Pregnant women will be excluded since, although none of the acupuncture points or
             combinations are contraindicated in pregnancy, the presence of morning sickness could
             serve as a potential confounding factor.

          6. Current users of acupuncture for treating GI symptoms.

          7. Current practice of relaxation response.

          8. Current enrollment in another clinical intervention study.

          9. Cognitive impairment as measured by Mini Mental Status Examination (MMSE), a reliable
             and valid screening instrument for the detection of cognitive impairment, using a
             commonly used cut-off point of 24.

         10. If use of Chinese herbs has been recently discontinued, a potential participant must
             have at least 2 weeks without herb use to be eligible for the study. Because use of
             herbs is occasionally accompanied by digestive disorders,a period of stabilizing is
             required before acupuncture treatment can be initiated. This washout period has been
             conservatively estimated by ACP staff herbalists to constitute a sufficient time for
             effects of herbs to cease.