Acupuncture for Nausea in HIV (NCT00624793) | Clinical Trial Compass
CompletedPhase 2
Acupuncture for Nausea in HIV
159 participantsStarted 2005-05
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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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 …
What they're measuring
1
INVR - symptom diary Clinical Global Impression Scales
Timeframe: Baseline, treatment and follow-ups sessions