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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

February 19, 2008
June 21, 2012
May 2005
November 2011   (final data collection date for primary outcome measure)
INVR - symptom diary Clinical Global Impression Scales [ Time Frame: Baseline, treatment and follow-ups sessions ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00624793 on ClinicalTrials.gov Archive Site
QOL scale MOS-SF-36 subscales [ Time Frame: Baseline, treatment and follow-up session ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Acupuncture for Nausea in HIV
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
HIV Infections
  • Other: Acupuncture
    Standard Acup point protocol for treating nausea
  • Other: Individualized Acup based on TCM diagnosis
    Acup
  • Other: Sham Acup
    Sham Acup - Non-Active
  • Experimental: I. Standard
    Standard - Formula Acup Protocol
    Intervention: Other: Acupuncture
  • Experimental: 2. Individualized
    Individualized Acup protocol based on TCM diagnosis
    Intervention: Other: Individualized Acup based on TCM diagnosis
  • Sham Comparator: 3
    (Control Group) Sham acupuncture
    Intervention: Other: Sham Acup
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
December 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00624793
09-0339
No
New York University School of Medicine
New York University School of Medicine
Not Provided
Principal Investigator: Joyce K Anastasi, PhD New York University
New York University School of Medicine
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP