HIV InfectionsPhase 2AcuNNCT00624793
Acupuncture for Nausea in HIV
A Phase 2 study testing Acupuncture and Individualized Acup based on TCM diagnosis in people with HIV Infections, run by NYU Langone Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Acupuncture and Individualized Acup based on TCM diagnosis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- HIV Infections
- Being tested
- Acupuncture, Individualized Acup based on TCM diagnosis, Sham Acup
- Keywords
- Nausea, Vomiting, Retching, HIV/AIDS, Symptom Management, Complementary Therapies
- Medical subject headings
- HIV Infections, Nausea, Vomiting, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Standard Acup point protocol for treating nausea
Individualized Acup based on TCM diagnosisOther
Acup
Sham AcupOther
Sham Acup - Non-Active
| Study group | Role | What they receive |
|---|---|---|
| I. Standard | Experimental | Standard - Formula Acup Protocol Receives: Other: Acupuncture |
| 2. Individualized | Experimental | Individualized Acup protocol based on TCM diagnosis Receives: Other: Individualized Acup based on TCM diagnosis |
| 3 | Sham comparator | (Control Group) Sham acupuncture Receives: Other: Sham Acup |
What is being measured
The primary outcome is the main question the study is designed to answer.
INVR - symptom diary Clinical Global Impression Scales
Measured: Baseline, treatment and follow-ups sessions
Secondary outcomes (1)
QOL scale MOS-SF-36 subscales
Measured: Baseline, treatment and follow-up session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2008 (estimated)
- Study startMay 2005
- Primary completionNov 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joyce K Anastasi, PhD, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624793
- Sponsor's protocol ID
- 09-0339
- Acronym
- AcuN
- Status last verified
- Jun 2012
- First submitted
- 19 Feb 2008
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Chronic Nausea in HIV: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00624793
- Acronym / sponsor ID
- AcuN / 09-0339
- Conditions
- HIV Infections
- Keywords
- Nausea, Vomiting, Retching, HIV/AIDS, Symptom Management, Complementary Therapies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I. Standard | Experimental | Other: AcupunctureStandard - Formula Acup Protocol |
| 2. Individualized | Experimental | Other: Individualized Acup based on TCM diagnosisIndividualized Acup protocol based on TCM diagnosis |
| 3 | Sham comparator | Other: Sham Acup(Control Group) Sham acupuncture |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureStandard Acup point protocol for treating nausea | Other | I. Standard |
| Individualized Acup based on TCM diagnosisAcup | Other | 2. Individualized |
| Sham AcupSham Acup - Non-Active | Other | 3 |
Primary outcome
INVR - symptom diary Clinical Global Impression Scales
Time frame: Baseline, treatment and follow-ups sessions
1 secondary outcome
QOL scale MOS-SF-36 subscales
Time frame: Baseline, treatment and follow-up session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce K Anastasi, PhD principal investigator
New York University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acupuncture and Individualized Acup based on TCM diagnosis in people with HIV Infections, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INVR - symptom diary Clinical Global Impression Scales (time frame: Baseline, treatment and follow-ups sessions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2012.