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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
INVR - symptom diary Clinical Global Impression Scales
Timeframe: Baseline, treatment and follow-ups sessions