Text Size

Acupuncture for Nausea in HIV (AcuN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00624793
First received: February 19, 2008
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Chronic Nausea in HIV: A Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ 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 ]

Enrollment: 159
Study Start Date: May 2005
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Joyce K Anastasi, PhD New York University
  More Information

No publications provided

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
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Nausea
Vomiting
Retching
 HIV/AIDS
Symptom Management
Complementary Therapies

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Nausea
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013