Acupuncture for Nausea in HIV

Phase 2

Completed

• Conditions: HIV Infections
• Interventions: Other: Acupuncture; Other: Sham Acup; Other: Individualized Acup based on TCM diagnosis

• Registration Number: NCT00624793
• Lead Sponsor: NYU Langone Health

Brief Summary

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

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-19
• Study First Posted: 2008-02-27
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 159

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I. Standard	Acupuncture	Standard - Formula Acup Protocol
3	Sham Acup	(Control Group) Sham acupuncture
2. Individualized	Individualized Acup based on TCM diagnosis	Individualized Acup protocol based on TCM diagnosis

Primary Outcome Measures

Name	Time	Method
INVR - symptom diary Clinical Global Impression Scales	Baseline, treatment and follow-ups sessions

Secondary Outcome Measures

Name	Time	Method
QOL scale MOS-SF-36 subscales	Baseline, treatment and follow-up session