A Study of Discontinuing Maintenance Therapy in Subjects With Disseminated Mycobacterium Avium Complex (DMAC)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2008-07-30
50
Participants Needed
24
Research Sites
N/A
Total Duration
On this page
AI-Summary
Official Title
Who Can Participate
Trial Site Locations
How is the study designed?
Frequently Asked Questions
Research Publications
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients
Who Can Participate
Age: 13Years +
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication
Currently pregnant or breastfeeding
Recent participation in another clinical trial within the last 30 days
Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 24 locations
1
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Status Unknown
2
Willow Clinic
Menlo Park, California, United States, 94025
Status Unknown
3
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Status Unknown
4
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
5
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
6
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States, 951282699
Status Unknown
7
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
Status Unknown
8
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Status Unknown
9
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
10
Univ of Miami School of Medicine
Miami, Florida, United States, 331361013
Status Unknown
11
Emory Univ
Atlanta, Georgia, United States, 30308
Status Unknown
12
Univ of Hawaii
Honolulu, Hawaii, United States, 96816
Status Unknown
13
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, United States, 60612
Status Unknown
14
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Status Unknown
15
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
Status Unknown
16
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
17
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
18
Beth Israel Med Ctr
New York, New York, United States, 10003
Status Unknown
19
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
20
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
21
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
22
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Status Unknown
23
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
24
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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A study of discontinuing maintenance therapy in human immunodeficiency virus-infected subjects with disseminated Mycobacterium avium complex: AIDS Clinical Trial Group 393 Study Team.