Ann Intern Med. 2000 Oct 3;133(7):493-503. Unique Identifier : AIDSLINE
BACKGROUND: Patients infected with HIV who experience increases in
CD4(+) cell counts are at reduced risk for opportunistic infections.
However, the safety of discontinuing prophylaxis against Mycobacterium
avium complex has been uncertain. OBJECTIVE: To compare the rate of M.
avium complex infection in patients with increased CD4(+) cell counts
who receive azithromycin and those receiving placebo. DESIGN:
Randomized, double-blind, placebo-controlled trial. SETTING: 29
university-based clinical centers in the United States. PARTICIPANTS:
643 HIV-1-infected patients with a previous CD4(+) cell count less than
0.05 x 10(9) cells/L and a sustained increase to greater than 0.10 x
10(9) cells/L during antiretroviral therapy. INTERVENTION: Azithromycin,
1200 mg once weekly (n = 321), or matching placebo (n = 322).
MEASUREMENTS: Mycobacterium avium complex cultures, CD4(+) cell counts,
and clinical evaluations for AIDS-defining illnesses and bacterial
infections were done every 8 weeks. Plasma HIV-1 RNA levels were
measured at 16-week intervals. RESULTS: During follow-up (median, 16
months), 2 cases of M. avium complex infection were reported among the
321 patients assigned to placebo (incidence rate, 0.5 event per 100
person-years [95% CI, 0.06 to 1.83 events per 100 person-years])
compared with no cases among the 322 patients assigned to azithromycin
(CI, 0 to 0.92 events per 100 person-years), resulting in a treatment
difference of 0.5 event per 100 person-years (CI, -0.20 to 1.21 events
per 100 person-years) for placebo versus azithromycin. Both cases were
atypical in that M. avium complex was localized to the vertebral spine.
Patients receiving azithromycin were more likely than those receiving
placebo to discontinue treatment with the study drug permanently because
of adverse events (8% vs. 2%; hazard ratio, 0.24 [CI, 0.10 to 0.57]).
CONCLUSIONS: Prophylaxis against Mycobacterium avium complex can safely
be withdrawn or withheld in adults with HIV infection who experience
increases in CD4(+) cell count while receiving antiretroviral therapy.
CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED
CONTROLLED TRIAL Adult Anti-HIV Agents/THERAPEUTIC USE Antibiotics,
Macrolide/ADVERSE EFFECTS/*THERAPEUTIC USE Azithromycin/ADVERSE
EFFECTS/*THERAPEUTIC USE AIDS-Related Opportunistic
Infections/*PREVENTION & CONTROL *CD4 Lymphocyte Count Disease
Progression Double-Blind Method Female Human HIV Infections/*DRUG
THERAPY/*IMMUNOLOGY/VIROLOGY HIV-1/GENETICS Immunocompromised Host
Male Mycobacterium avium Complex Mycobacterium avium-intracellulare
Infection/*PREVENTION & CONTROL Placebos Proportional Hazards Models
RNA, Viral/BLOOD Support, Non-U.S. Gov't Support, U.S. Gov't, P.H.S.