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

This study has been completed.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00000907
  Purpose

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.


Condition
Mycobacterium Avium-Intracellulare Infection
HIV Infections

MedlinePlus related topics:   AIDS    AIDS Medicines   

U.S. FDA Resources

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

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:   50

Detailed 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.

  Eligibility
Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000907

Locations
United States, California
Univ of California / San Diego Treatment Ctr    
      San Diego, California, United States, 921036325
San Francisco Gen Hosp    
      San Francisco, California, United States, 941102859
San Francisco AIDS Clinic / San Francisco Gen Hosp    
      San Francisco, California, United States, 941102859
San Mateo AIDS Program / Stanford Univ    
      Stanford, California, United States, 943055107
Univ of Southern California / LA County USC Med Ctr    
      Los Angeles, California, United States, 900331079
Stanford Univ Med Ctr    
      Stanford, California, United States, 943055107
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium    
      San Jose, California, United States, 951282699
Willow Clinic    
      Menlo Park, California, United States, 94025
United States, Colorado
Univ of Colorado Health Sciences Ctr    
      Denver, Colorado, United States, 80262
United States, Florida
Univ of Miami School of Medicine    
      Miami, Florida, United States, 331361013
United States, Georgia
Emory Univ    
      Atlanta, Georgia, United States, 30308
United States, Hawaii
Univ of Hawaii    
      Honolulu, Hawaii, United States, 96816
United States, Illinois
Rush Presbyterian - Saint Luke's Med Ctr    
      Chicago, Illinois, United States, 60612
United States, Indiana
Indiana Univ Hosp    
      Indianapolis, Indiana, United States, 462025250
Division of Inf Diseases/ Indiana Univ Hosp    
      Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins Hosp    
      Baltimore, Maryland, United States, 21287
United States, New York
Bellevue Hosp / New York Univ Med Ctr    
      New York, New York, United States, 10016
Mount Sinai Med Ctr    
      New York, New York, United States, 10029
SUNY / Erie County Med Ctr at Buffalo    
      Buffalo, New York, United States, 14215
Beth Israel Med Ctr    
      New York, New York, United States, 10003
United States, North Carolina
Univ of North Carolina    
      Chapel Hill, North Carolina, United States, 275997215
United States, Ohio
Univ of Cincinnati    
      Cincinnati, Ohio, United States, 452670405
United States, Pennsylvania
Univ of Pennsylvania at Philadelphia    
      Philadelphia, Pennsylvania, United States, 19104
United States, South Carolina
Julio Arroyo    
      West Columbia, South Carolina, United States, 29169

Sponsors and Collaborators

Investigators
Study Chair:     Judith Aberg    
Study Chair:     Judith Currier    
  More Information


Haga clic aquí para ver información sobre este ensayo clínico en español.  This link exits the ClinicalTrials.gov site
 

Publications:
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)
 
Aberg JA, Williams PL, Liu T, Lederman HM, Hafner R, Torriani FJ, Lennox JL, Dube MP, MacGregor RR, Currier JS. 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.
 

Study ID Numbers:   ACTG 393, AACTG 393
First Received:   November 2, 1999
Last Updated:   July 29, 2008
ClinicalTrials.gov Identifier:   NCT00000907
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
AIDS-Related Opportunistic Infections  
Mycobacterium avium-intracellulare Infection  
Immunity, Cellular  
Antibiotics, Macrolide  
Mycobacterium avium Complex
CD4 Lymphocyte Count
Disease Progression
Anti-HIV Agents

Study placed in the following topic categories:
Bacterial Infections
Opportunistic Infections
Sexually Transmitted Diseases, Viral
Acquired Immunodeficiency Syndrome
Disease Progression
Mycobacterium Infections, Atypical
Immunologic Deficiency Syndromes
Mycobacterium avium-intracellulare Infection
Virus Diseases
Gram-Positive Bacterial Infections
HIV Seropositivity
HIV Infections
AIDS-Related Opportunistic Infections
Sexually Transmitted Diseases
Mycobacterium Infections
Mycobacterium avium complex infection
Retroviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection
Actinomycetales Infections

ClinicalTrials.gov processed this record on December 03, 2008




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