A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients
NCT ID: NCT00000907
Last Updated: 2008-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
50 participants
OBSERVATIONAL
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Eligibility Criteria
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Inclusion Criteria
* 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
* Have any active infection (unless they have been on stable chronic suppressive therapy for at least 3 months).
* Are pregnant.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Judith Aberg
Role: STUDY_CHAIR
Judith Currier
Role: STUDY_CHAIR
Locations
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Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
Willow Clinic
Menlo Park, California, 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
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Univ of Miami School of Medicine
Miami, Florida, United States
Emory Univ
Atlanta, Georgia, United States
Univ of Hawaii
Honolulu, Hawaii, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Beth Israel Med Ctr
New York, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States
Julio Arroyo
West Columbia, South Carolina, United States
Countries
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References
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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; 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. doi: 10.1086/368413. Epub 2003 Mar 14.
Other Identifiers
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AACTG 393
Identifier Type: -
Identifier Source: secondary_id
ACTG 393
Identifier Type: -
Identifier Source: org_study_id