A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients
A Study of Discontinuing Maintenance Therapy in Subjects With Disseminated Mycobacterium Avium Complex (DMAC)
2 other identifiers
observational
50
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJuly 30, 2008
June 1, 2003
November 2, 1999
July 29, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
Willow Clinic
Menlo Park, California, 94025, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Univ of Miami School of Medicine
Miami, Florida, 331361013, United States
Emory Univ
Atlanta, Georgia, 30308, United States
Univ of Hawaii
Honolulu, Hawaii, 96816, United States
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Beth Israel Med Ctr
New York, New York, 10003, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Related Publications (2)
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)
BACKGROUNDAberg 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.
PMID: 12660918BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Judith Aberg
- STUDY CHAIR
Judith Currier
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
July 30, 2008
Record last verified: 2003-06