Acupuncture for Nausea in HIV

HIV Infections Clinical Trial

— AcuN  

Official title:

Acupuncture for Chronic Nausea in HIV: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00624793
• Other study ID #: 09-0339
• Status: Completed
• Phase: Phase 2
• First received: February 19, 2008
• Last updated: June 21, 2012
• Start date: May 2005
• Est. completion date: December 2011

Study information

• Verified date: June 2012
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Other:
• Acupuncture
Standard Acup point protocol for treating nausea
• Individualized Acup based on TCM diagnosis
Acup
• Sham Acup
Sham Acup - Non-Active

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	INVR - symptom diary Clinical Global Impression Scales		Baseline, treatment and follow-ups sessions	No
Secondary	QOL scale MOS-SF-36 subscales		Baseline, treatment and follow-up session	No