NCT00064740

Brief Summary

Advances in treatment has turned HIV/AIDS into a chronic illness. Relaxation response is a state in which individuals evoke a bodily calm, effecting physiological changes that are shown to be associated with improved immune functioning. Acupuncture and relaxation are thought to both induce calm and deep relaxation in mind and body. This trial will study the combined effects of acupuncture and relaxation response in HIV patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 14, 2003

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

August 18, 2006

Status Verified

August 1, 2006

First QC Date

July 11, 2003

Last Update Submit

August 16, 2006

Conditions

Human Immunodeficiency VirusAIDS

Keywords

Human Immunodeficiency VirusesRelaxationAcupunctureComplementary therapies

Interventions

relaxation responseBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV positive
  • First time and long-term acupuncture users
  • Symptomatic criteria including: sinus problem, headache, dental pain/sore or bleeding gums, nausea, diarrhea, vomiting, muscle aches, joint pain, neuropathy, weakness, anxiety, depression, and insomnia

You may not qualify if:

  • Patients suffering from acute symptoms
  • Patients with acute opportunistic infections
  • Patients currently practicing relaxation response
  • Patients currently enrolled in another intervention study
  • Cognitive impairment as measured by MMSE (Mini Mental Status Examination)
  • Lack of English proficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aids Care Program

Boston, Massachusetts, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Bei-Hung Chang, Sc.D

    Assistant Professor at Boston University School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2003

First Posted

July 14, 2003

Study Start

July 1, 2003

Study Completion

March 1, 2006

Last Updated

August 18, 2006

Record last verified: 2006-08

Locations

US(1)