HIV Infections Clinical Trial
Official title:
A Study of Discontinuing Maintenance Therapy in Subjects With Disseminated Mycobacterium Avium Complex (DMAC)
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.
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.
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