NCT00010491

Brief Summary

The objective of this study is to test alternative treatment strategies to reduce the frequency of chronic diarrhea among HIV positive individuals. 60 percent of patients with HIV disease in the U.S. will have diarrhea at some point in their illness. Although in general many of the opportunistic infections (OI's) associated with HIV have decreased due to new "drug cocktails", many of these drugs, however, have diarrhea as a side effect. In Asian countries, acupuncture (including moxibustion) has been widely used for the treatment of various gastrointestinal (GI) disorders. However, there are no published studies that test treatment protocols using acupuncture or moxibustion on patients with HIV experiencing chronic diarrhea.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 1999

Typical duration for phase_2 hiv-infections

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2001

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

March 7, 2008

Status Verified

March 1, 2008

First QC Date

February 2, 2001

Last Update Submit

March 5, 2008

Conditions

HIV Infections

Keywords

Diarrheacomplementary therapies

Interventions

AcupuncturePROCEDURE
MoxibustionPROCEDURE

Eligibility Criteria

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

You may qualify if:

  • HIV seropositive experiencing non-pathogen related diarrhea 3 or more times per 24 hours for a period of 3 weeks or more.
  • Able to speak and read English or Spanish

You may not qualify if:

  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, United States

Location

MeSH Terms

Conditions

HIV InfectionsDiarrhea

Interventions

Acupuncture TherapyMoxibustion

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Joyce K. Anastasi, PhD,RN,LAc

    School of Nursing

    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

February 2, 2001

First Posted

February 5, 2001

Study Start

September 1, 1999

Study Completion

August 1, 2003

Last Updated

March 7, 2008

Record last verified: 2008-03

Locations

US(1)