Acupuncture for Nausea in HIV (AcuN)

Acupuncture for Chronic Nausea in HIV: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Other: Acupuncture; Other: Individualized Acup based on TCM diagnosis; Other: Sham Acup

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 Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health

Study record dates

Study Major Dates

• Study Start: May 1, 2005
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 19, 2008
• First Submitted That Met QC Criteria: February 19, 2008
• First Posted (Estimate): February 27, 2008

Study Record Updates

• Last Update Posted (Estimate): June 22, 2012
• Last Update Submitted That Met QC Criteria: June 21, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Nausea; Vomiting; Complementary Therapies; HIV/AIDS; Symptom Management; Retching
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea
• Other Study ID Numbers: 09-0339