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NCT00000907 Clinical Trial

A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients

HIV Infections Clinical Trial

Official title:
A Study of Discontinuing Maintenance Therapy in Subjects With Disseminated Mycobacterium Avium Complex (DMAC)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000907
Other study ID # ACTG 393
Secondary ID AACTG 393
Status Completed
Phase N/A
First received November 2, 1999
Last updated July 29, 2008

Study information
Verified date June 2003
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the effects of stopping preventive therapy for DMAC in HIV-positive patients who (1) have been treated for DMAC for at least 12 months and are now free of any signs of DMAC for at least 16 weeks, and (2) have improved immune systems (CD4 cell counts greater than or equal to 100 cells/mm3) due to anti-HIV drug therapy.

DMAC is a serious and sometimes life-threatening infection that usually affects only HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) less than 50 cells/mm3. It is recommended that people who are likely to get DMAC be placed on preventive medications which help reduce the risk of infection. New anti-HIV combination drug therapies can increase CD4 cell counts and can reduce the level of HIV in the blood. When CD4 counts are increased, risk of DMAC infection is less. This study examines whether it is possible to stop preventive therapy for DMAC when CD4 counts are high without placing individuals at risk for getting DMAC again.

Description:

A growing body of evidence suggests AIDS-related morbidity and mortality significantly decrease where potent antiretroviral therapies are used. HAART (highly active antiretroviral therapy) seems to significantly reduce the incidence of MAC. This study tests the validity of those observations.

Peripheral blood cultures and bone marrow (aspirate) samples from 50 eligible patients previously diagnosed with disseminated Mycobacterium avium complex (DMAC) are assessed for microbiologic sterilization of MAC at the time of study entry. If either bone marrow or blood cultures test positive for MAC, patients are discontinued from study. If cultures prove sterile, patients receive 6 weeks of treatment and then discontinue MAC therapy at Week 6 (entry into Step 2 of study). They are then monitored for clinical signs and symptoms of MAC recurrence and for the presence of mycobacteria in blood cultures. In cases of increased viral load during study, modification of antiretroviral therapy is allowed at the discretion of the patient's provider.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 13 Years and older
Eligibility Inclusion Criteria

Patients may be eligible for this study if they:

- Are HIV-positive.

- Have 2 CD4 cell counts greater than or equal to 100 cells/mm3 within 60 days and 14 days prior to entry. Measurements must be taken at least 24 hours apart.

- Have been treated for DMAC with a drug regimen including at least 2 antimycobacterial drugs for at least 12 months, and have been free of symptoms for at least 16 weeks prior to study entry.

- Have been on anti-HIV therapy for at least 16 weeks and have been on stable anti-HIV therapy for at least 8 weeks prior to study entry.

- Are at least 13 years old (need consent of parent or guardian if under 18).

Exclusion Criteria

Patients will not be eligible for this study if they:

- Have any active infection (unless they have been on stable chronic suppressive therapy for at least 3 months).

- Are pregnant.

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
United States Emory Univ Atlanta Georgia
United States Johns Hopkins Hosp Baltimore Maryland
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Univ of North Carolina Chapel Hill North Carolina
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Univ of Cincinnati Cincinnati Ohio
United States Univ of Colorado Health Sciences Ctr Denver Colorado
United States Univ of Hawaii Honolulu Hawaii
United States Division of Inf Diseases/ Indiana Univ Hosp Indianapolis Indiana
United States Indiana Univ Hosp Indianapolis Indiana
United States Univ of Southern California / LA County USC Med Ctr Los Angeles California
United States Willow Clinic Menlo Park California
United States Univ of Miami School of Medicine Miami Florida
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Beth Israel Med Ctr New York New York
United States Mount Sinai Med Ctr New York New York
United States Univ of Pennsylvania at Philadelphia Philadelphia Pennsylvania
United States Univ of California / San Diego Treatment Ctr San Diego California
United States San Francisco AIDS Clinic / San Francisco Gen Hosp San Francisco California
United States San Francisco Gen Hosp San Francisco California
United States Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium San Jose California
United States San Mateo AIDS Program / Stanford Univ Stanford California
United States Stanford Univ Med Ctr Stanford California
United States Julio Arroyo West Columbia South Carolina

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Aberg JA, Williams PL, Liu T, Lederman HM, Hafner R, Torriani FJ, Lennox JL, Dube MP, MacGregor RR, Currier JS; AIDS Clinical Trial Group 393 Study Team. A study of discontinuing maintenance therapy in human immunodeficiency virus-infected subjects with disseminated Mycobacterium avium complex: AIDS Clinical Trial Group 393 Study Team. J Infect Dis. 2003 Apr 1;187(7):1046-52. Epub 2003 Mar 14. Erratum in: J Infect Dis. 2003 Apr 15;187(8):1346. — View Citation

Aberg, C. A study of discontinuing maintenance therapy in subjects with disseminated Mycobacterium avium complex. Program and abstracts of the 9th Conference on Retroviruses and Opportunistic Infections. 9th Conference on Retroviruses and Opportunistic Infections. 2002, February 24-28; Seattle Washington (abstract no634)

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