Acupuncture for Nausea in HIV - Full Text View

Sponsored by:	Columbia University
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00624793

Purpose

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.

Condition	Intervention	Phase
HIV Infections	Other: Acupuncture Other: Individualized Acup based on TCM diagnosis Other: Sham Acup	Phase II

MedlinePlus related topics: AIDS Acupuncture Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Acup for Chronic Nausea in HIV: A RCT

Further study details as provided by Columbia University:

Primary Outcome Measures:

INVR - symptom diary Clinical Global Impression Scales [ Time Frame: Baseline, treatment and follow-ups sessions ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

QOL scale MOS-SF-36 subscales [ Time Frame: Baseline, treatment and follow-up session ] [ Designated as safety issue: No ]

Estimated Enrollment:	159
Study Start Date:	May 2005
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I. Standard: Experimental Standard - Formula Acup Protocol	Other: Acupuncture Standard Acup point protocol for treating nausea
2. Individualized: Experimental Individualized Acup protocol based on TCM diagnosis	Other: Individualized Acup based on TCM diagnosis Acup
3: Sham Comparator (Control Group) Sham acupuncture	Other: Sham Acup Sham Acup - Non-Active

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624793

Contacts

Contact: Ann M Chung	212-305-3041	amc103@columbia.edu
Contact: Colin Scully	212-305-3041

Locations

United States, New York
Center for AIDS Research (CFAR): Columbia University School of Nursing	Recruiting
New York, New York, United States, 10032
Contact: Ann M Chung 212-305-3041
Contact: Colin Scully 212-305-3041
Principal Investigator: Joyce K Anastasi, PhD

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

Joyce K Anastasi, PhD

Columbia University

More Information

Responsible Party:	Columbia University School of Nursing ( Joyce K. Anastasi, PhD )
Study ID Numbers:	AAAA9068
Study First Received:	February 19, 2008
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00624793
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

Nausea
Vomiting
Retching

HIV/AIDS
Symptom Management
Complementary Therapies

Study placed in the following topic categories:

Virus Diseases
Sexually Transmitted Diseases, Viral
Vomiting
HIV Infections
Sexually Transmitted Diseases

Acquired Immunodeficiency Syndrome
Nausea
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 16, 2009