Acupuncture for Nausea in HIV

Study Overview
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Brief Summary
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The subjects in this research study will be 159 men and women with HIV infection who have a history of chronic nausea for three months or greater and show evidence of two or more episodes of nausea and/or report a duration of two hours or more (per day) in baseline symptom diaries. Subjects will be randomized (by chance) to one of three conditions: Condition 1, subjects receive Standard acupuncture (active treatment); Condition 2, subjects receive Individualized acupuncture based on Traditional Chinese Medical Diagnosis (active treatment); Condition 3, (Control Group), subjects receive Sham acupuncture. Subjects in Conditions 1, 2, & 3 will attend scheduled sessions over 24 weeks.

Detailed Description
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The subjects in the proposed experiment will be 159 men and women with HIV infection who have a history of chronic nausea for three months or greater and show evidence of two or more episodes of nausea and/or report a duration of 2 hours or greater (per day) in prospective baseline symptom diaries. Subjects will be randomized to one of three experimental intervention conditions: Condition 1, subjects receive Standard acupuncture; Condition 2, subjects receive Individualized acupuncture based on Traditional Chinese Medical Diagnosis; Condition 3, (Control Group), subjects receive Sham acupuncture. Subjects in Conditions 1, 2, & 3 will attend 16 scheduled sessions over 24 weeks. All subjects will: be assessed by a diagnostic acupuncturist (blinded to treatment assignments); be administered the same instruments; and submit their symptom diaries for data entry and analysis. After a screening/intake session, randomization and treatment sessions will follow. There will be four weeks of twice weekly treatment sessions, four weekly treatment sessions and three follow-up sessions. All conditions will be identical in duration and be administered by licensed acupuncturists trained in Traditional Chinese Medicine. This study is a prospective, randomized, controlled, blinded (subject and evaluator), parallel groups clinical trial aimed at reducing chronic nausea and improving quality of life in persons with HIV/AIDS.

Official Title
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Acupuncture for Chronic Nausea in HIV: A Randomized Clinical Trial

Conditions
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HIV Infections

Intervention / Treatment
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* Other: Acupuncture
* Other: Individualized Acup based on TCM diagnosis
* Other: Sham Acup


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women HIV positive or CDC AIDS diagnosed History of chronic nausea for three months or greater Experience an average of two or more episodes of nausea and/or who experience an average duration of 2 hours or more (of nausea) per day Verification from Primary provider of subject's: HIV status, knowledge of patient's nausea and their agreement that their patient is clinically suitable for the study. Individuals able to successfully complete a mini-mental status exam Individuals who understand and agree to complete daily symptom diaries for the duration of the study. Individuals taking antiretroviral combinations must have completed an initial 8 weeks of a stable regime (same drug(s), dose & frequency) prior to entry into the study. Individuals taking anti-emetic medications must be on a stable regime (same drug, dose & frequency) for at least fourteen days prior to entry into the study. Individuals on all other medications which may have nausea listed as a side effect must be on a stable regime (same drug(s), dose & frequency) for at least fourteen (14) days prior to entry in the study Exclusion Criteria: Individuals with an acute medical condition, i.e. pneumocystis carinii pneumonia, tuberculosis and or other opportunistic infections or conditions that would require medical attention. Pregnant women Individuals receiving acupuncture currently and less than 6 months prior to enrollment. Individuals currently receiving other types of complementary therapies such as herbs, massage, acupressure wrist bands, reiki etc. Individuals with plans for travel, lifestyle change, or other activity that would preclude attending all of the planned study sessions and/or recording daily diary information.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I. Standard<br>Standard - Formula Acup Protocol | Other: Acupuncture<br>* Standard Acup point protocol for treating nausea<br>|
| Experimental: 2. Individualized<br>Individualized Acup protocol based on TCM diagnosis | Other: Individualized Acup based on TCM diagnosis<br>* Acup<br>|
| Sham Comparator: 3<br>(Control Group) Sham acupuncture | Other: Sham Acup<br>* Sham Acup - Non-Active<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INVR - symptom diary Clinical Global Impression Scales |  | Baseline, treatment and follow-ups sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL scale MOS-SF-36 subscales |  | Baseline, treatment and follow-up session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nausea, Vomiting, Retching, HIV/AIDS, Symptom Management, Complementary Therapies