Acupuncture for Nausea in HIV (AcuN)
New York University School of Medicine
Information provided by (Responsible Party)
New York University School of Medicine
First received: February 19, 2008
Last updated: June 21, 2012
Last Verified: June 2012
History of Changes
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.
Other : Acupuncture
Other : Individualized Acup based on TCM diagnosis
Other : Sham Acup
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Acupuncture for Chronic Nausea in HIV: A Randomized Clinical Trial|
Further study details as provided by New York University School of Medicine:
Primary Outcome Measures
- INVR - symptom diary Clinical Global Impression Scales [ Time Frame: Baseline, treatment and follow-ups sessions ]
- QOL scale MOS-SF-36 subscales [ Time Frame: Baseline, treatment and follow-up session ]
|Study Start Date:||May 2005|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Standard - Formula Acup Protocol
Standard Acup point protocol for treating nausea
Individualized Acup protocol based on TCM diagnosis
Individualized Acup based on TCM diagnosis
(Control Group) Sham acupuncture
Sham Acup - Non-Active
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|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624793
Sponsors and CollaboratorsNew York University School of Medicine
|Principal Investigator:||Joyce K Anastasi, PhD||New York University|
|Responsible Party:||New York University School of Medicine|
|ClinicalTrials.gov Identifier:||NCT00624793 History of Changes|
|Other Study ID Numbers:||09-0339|
|Study First Received:||February 19, 2008|
|Last Updated:||June 21, 2012|
Keywords provided by New York University School of Medicine:Nausea
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on September 25, 2018
This information is provided by ClinicalTrials.gov.