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 to F/U.
      
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 HIV.

Key Words: CD4 rebound, MAC prophylaxis, OI prophylaxis

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