Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-03 @ 9:20 AM
Study NCT ID:
NCT00624793
Status:
COMPLETED
Last Update Posted:
2012-06-22
First Post:
2008-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acupuncture for Nausea in HIV
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-21', 'studyFirstSubmitDate': '2008-02-19', 'studyFirstSubmitQcDate': '2008-02-19', 'lastUpdatePostDateStruct': {'date': '2012-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'INVR - symptom diary Clinical Global Impression Scales', 'timeFrame': 'Baseline, treatment and follow-ups sessions'}], 'secondaryOutcomes': [{'measure': 'QOL scale MOS-SF-36 subscales', 'timeFrame': 'Baseline, treatment and follow-up session'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Nausea', 'Vomiting', 'Retching', 'HIV/AIDS', 'Symptom Management', 'Complementary Therapies'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men and women HIV positive or CDC AIDS diagnosed\n* History of chronic nausea for three months or greater\n* 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\n* 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.\n* Individuals able to successfully complete a mini-mental status exam\n* Individuals who understand and agree to complete daily symptom diaries for the duration of the study.\n* 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.\n* 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.\n* 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\n\nExclusion Criteria:\n\n* Individuals with an acute medical condition, i.e. pneumocystis carinii pneumonia, tuberculosis and or other opportunistic infections or conditions that would require medical attention.\n* Pregnant women\n* Individuals receiving acupuncture currently and less than 6 months prior to enrollment.\n* Individuals currently receiving other types of complementary therapies such as herbs, massage, acupressure wrist bands, reiki etc.\n* 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."}, 'identificationModule': {'nctId': 'NCT00624793', 'acronym': 'AcuN', 'briefTitle': 'Acupuncture for Nausea in HIV', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Acupuncture for Chronic Nausea in HIV: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '09-0339'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'I. Standard', 'description': 'Standard - Formula Acup Protocol', 'interventionNames': ['Other: Acupuncture']}, {'type': 'EXPERIMENTAL', 'label': '2. Individualized', 'description': 'Individualized Acup protocol based on TCM diagnosis', 'interventionNames': ['Other: Individualized Acup based on TCM diagnosis']}, {'type': 'SHAM_COMPARATOR', 'label': '3', 'description': '(Control Group) Sham acupuncture', 'interventionNames': ['Other: Sham Acup']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'description': 'Standard Acup point protocol for treating nausea', 'armGroupLabels': ['I. Standard']}, {'name': 'Individualized Acup based on TCM diagnosis', 'type': 'OTHER', 'description': 'Acup', 'armGroupLabels': ['2. Individualized']}, {'name': 'Sham Acup', 'type': 'OTHER', 'description': 'Sham Acup - Non-Active', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joyce K Anastasi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}