Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00010491
Other study ID # R01 AT000146-01M
Secondary ID R01AT000146-01R0
Status Completed
Phase Phase 2
First received February 2, 2001
Last updated March 5, 2008
Start date September 1999
Est. completion date August 2003

Study information

Verified date March 2008
Source National Center for Complementary and Integrative Health (NCCIH)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


Description:

The subjects in the study will be 144 men and women with HIV infection who report experiencing 3 or more episodes of diarrhea (non-pathogen related) per 24 hour period for 3 weeks or more. Subjects will be randomized to one of four experimental intervention conditions: Condition 1 subjects receive true acupuncture and true moxibustion; Condition 2 subjects receive true acupuncture and placebo moxibustion; Condition 3, subjects receive true moxibustion and sham acupuncture; Condition 4( Control Group), subjects receive sham acupuncture and placebo moxibustion. Subjects in Conditions 1,2,3,& 4 will attend 20 scheduled sessions over 24 weeks. Week 1 is a baseline session followed by two sessions per week for weeks 2-8 (sessions 2-15), one session per week for weeks 9, 10, 11 and 12 (sessions 16, 17, 18 & 19) and a final follow-up session at week 24. All subjects will complete daily bowel movement and medication data collection diaries for the duration of the study. Measurement of quality of life and level of functioning will be taken pre-intervention (session 1), week 6 (session 10), week 12 (session 19) and week 24 (session 20). All interventions will be implemented by licensed acupuncturists trained in traditional Chinese medicine. This study is designed to assess the efficacy of two alternative medicine treatments for chronic diarrhea associated with HIV in a prospective, randomized, controlled, blinded, parallel groups study under the intent-to-treat principle. True acupuncture, moxibustion, and combination therapy, in which specific meridian points are stimulated according to protocol, will be compared to each other and with the control group, with one-way ANOVA models for pre-treatment minus post-treatment difference scores for diarrhea frequency and stool consistency as the dependent measures and treatment group assignment (Conditions 1 - 4) as the independent variable. Average pretreatment diarrhea frequency and stool consistency scores will be entered as covariates into these models. Sample size determination for the above analysis, based on preliminary data, with 80% power and a two-tailed type I error rate of .05% by the method of Holm (1979) and a 20% attrition factor indicates the need for 36 subjects assigned to each condition to detect a 0.95-standardized difference between the most extreme experimental conditions.


Other known NCT identifiers
  • NCT00009074

Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date August 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Pregnant women

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Acupuncture

Moxibustion


Locations

Country Name City State
United States Columbia University New York New York

Sponsors (1)

Lead Sponsor Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Completed NCT05454514 - Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS N/A
Completed NCT03760458 - The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age Phase 1/Phase 2
Completed NCT03141918 - Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS N/A
Completed NCT03067285 - A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study Phase 4
Recruiting NCT04579146 - Coronary Artery Disease (CAD) in Patients HIV-infected
Completed NCT06212531 - Papuan Indigenous Model of Male Circumcision N/A
Active, not recruiting NCT03256422 - Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients Phase 3
Completed NCT03256435 - Retention in PrEP Care for African American MSM in Mississippi N/A
Completed NCT00517803 - Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies N/A
Active, not recruiting NCT03572335 - Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
Completed NCT04165200 - Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV N/A
Recruiting NCT03854630 - Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection Phase 4
Terminated NCT03275571 - HIV, Computerized Depression Therapy & Cognition N/A
Completed NCT02234882 - Study on Pharmacokinetics Phase 1
Completed NCT01618305 - Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission Phase 4
Recruiting NCT05043129 - Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Recruiting NCT04985760 - Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy Phase 1
Completed NCT05916989 - Stimulant Use and Methylation in HIV
Terminated NCT02116660 - Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284) Phase 2