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Acupuncture for Nausea in HIV (AcuN)

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Acupuncture
Individualized Acup based on TCM diagnosis
Sham Acup
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Nausea, Vomiting, Retching, HIV/AIDS, Symptom Management, Complementary Therapies

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Sham Comparator

    Arm Label

    I. Standard

    2. Individualized

    3

    Arm Description

    Standard - Formula Acup Protocol

    Individualized Acup protocol based on TCM diagnosis

    (Control Group) Sham acupuncture

    Outcomes

    Primary Outcome Measures

    INVR - symptom diary Clinical Global Impression Scales

    Secondary Outcome Measures

    QOL scale MOS-SF-36 subscales

    Full Information

    First Posted
    February 19, 2008
    Last Updated
    June 21, 2012
    Sponsor
    NYU Langone Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00624793
    Brief Title
    Acupuncture for Nausea in HIV
    Acronym
    AcuN
    Official Title
    Acupuncture for Chronic Nausea in HIV: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2005 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    December 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    NYU Langone Health

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    HIV Infections
    Keywords
    Nausea, Vomiting, Retching, HIV/AIDS, Symptom Management, Complementary Therapies

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    159 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    I. Standard
    Arm Type
    Experimental
    Arm Description
    Standard - Formula Acup Protocol
    Arm Title
    2. Individualized
    Arm Type
    Experimental
    Arm Description
    Individualized Acup protocol based on TCM diagnosis
    Arm Title
    3
    Arm Type
    Sham Comparator
    Arm Description
    (Control Group) Sham acupuncture
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture
    Intervention Description
    Standard Acup point protocol for treating nausea
    Intervention Type
    Other
    Intervention Name(s)
    Individualized Acup based on TCM diagnosis
    Intervention Description
    Acup
    Intervention Type
    Other
    Intervention Name(s)
    Sham Acup
    Intervention Description
    Sham Acup - Non-Active
    Primary Outcome Measure Information:
    Title
    INVR - symptom diary Clinical Global Impression Scales
    Time Frame
    Baseline, treatment and follow-ups sessions
    Secondary Outcome Measure Information:
    Title
    QOL scale MOS-SF-36 subscales
    Time Frame
    Baseline, treatment and follow-up session

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joyce K Anastasi, PhD
    Organizational Affiliation
    New York University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Acupuncture for Nausea in HIV

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