A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients
- Conditions
- Mycobacterium Avium-Intracellulare InfectionHIV Infections
- Registration Number
- NCT00000907
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Univ of Southern California / LA County USC Med Ctr
🇺🇸Los Angeles, California, United States
San Mateo AIDS Program / Stanford Univ
🇺🇸Stanford, California, United States
Univ of Miami School of Medicine
🇺🇸Miami, Florida, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Willow Clinic
🇺🇸Menlo Park, California, United States
Univ of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Mount Sinai Med Ctr
🇺🇸New York, New York, United States
Univ of California / San Diego Treatment Ctr
🇺🇸San Diego, California, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
🇺🇸San Jose, California, United States
San Francisco Gen Hosp
🇺🇸San Francisco, California, United States
Division of Inf Diseases/ Indiana Univ Hosp
🇺🇸Indianapolis, Indiana, United States
Julio Arroyo
🇺🇸West Columbia, South Carolina, United States
Rush Presbyterian - Saint Luke's Med Ctr
🇺🇸Chicago, Illinois, United States
Univ of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Univ of Pennsylvania at Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Beth Israel Med Ctr
🇺🇸New York, New York, United States
Johns Hopkins Hosp
🇺🇸Baltimore, Maryland, United States
Stanford Univ Med Ctr
🇺🇸Stanford, California, United States
Univ of Colorado Health Sciences Ctr
🇺🇸Denver, Colorado, United States
Univ of Hawaii
🇺🇸Honolulu, Hawaii, United States
Bellevue Hosp / New York Univ Med Ctr
🇺🇸New York, New York, United States
SUNY / Erie County Med Ctr at Buffalo
🇺🇸Buffalo, New York, United States