Clinical trial NCT00624793: Acupuncture for Nausea in HIV
Official title: Acupuncture for Chronic Nausea in HIV: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Nausea
Vomiting
Retching
HIV/AIDS
Symptom Management
Complementary Therapies
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2008-02-27
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: INVR - symptom diary Clinical Global Impression Scales
timeFrame: Baseline, treatment and follow-ups sessions
Secondary outcomes:
measure: QOL scale MOS-SF-36 subscales
timeFrame: Baseline, treatment and follow-up session
Other outcomes:
Locations:
Study officials:
affiliation: New York University
name: Joyce K Anastasi, PhD
role: PRINCIPAL_INVESTIGATOR
References: