Prophylaxis for Mycobacterium avium Complex Can Be Deferred among Patients with a Past CD4 Count <50 cells/mm3 Who Responded to Antiretroviral Therapy: Results of a Placebo-Controlled Trial (CPCRA 048)
W. M. EL-SADR*, W. BURMAN, L. GRANT, J. P. MATTS, D. ZEH, L. CRANE, B. GALLAGHER, F. GORDIN, and R. HAFNER.
The Terry Beirn Community Programs for Clin. Res. on AIDS
Background: Recent data suggest that immune response to ART may
protect against MAC and other opportunistic infections (Ols). However,
no data are available from prospective clinical trials on whether to continue
PROPHY for MAC in such pts.
Methods: Pts with CD4 rebound from <50 to >100 cells/mm3
due to ART were randomized to azithromycin (AZI) 1200mg weekly versus
PLC to prevent MAC or bacterial pneumonia (BP).
Results: Of 520 patients; 37% were African American, 14% were Hispanic,
12% were women, mean nadir CD4 was 24/mm3 and 65% had prior
AIDS-defining OIs. At baseline, mean CD4 was 261/mm3, 48% had
below detectable HIV RNA levels (<400 copies by PCR or <500 by bDNA),
69% had prior MAC PROPHY. Median follow-up (F/U):12 months with 0.6% lost
The 95% CI for MAC in the PLC group was 0.0 to 1.5 per 100 person yrs.
At 12 months, the CD4 cell count rose by a mean of 39 cells/mm3
and 52% of pts had HIV RNA below the level of detection.
Conclusions: AZI can be deferred in pts whose CD4 cell counts increase
from <50 to >100 cells/mm3 in response to ART. There were no
significant differences between AZI and PLC in the risk of MAC or BP,
progression of HIV disease, or survival. The study provides evidence that
ART can lead to substantial immune reconstitution in pts with advanced
Key Words: CD4 rebound, MAC prophylaxis, OI prophylaxis