Purpose: To describe the course of cytomegalovirus (CMV) retinitis in patients with AIDS in the era of highly active antiretroviral therapy (HAART).
Design: Multicenter, prospective, observational study.
Participants: Two hundred seventy-one patients with AIDS and CMV retinitis.
Methods: Follow-up every 3 months with medical history, ophthalmologic examination, laboratory testing, and fundus photographs.
Main outcome measure: Second (contralateral) eye involvement among patients with unilateral disease and retinal detachment (RD).
Results: The overall rate of second eye involvement among patients with unilateral CMV retinitis was 0.07 per person-year (PY); among those with CD4+ T-cell counts of <50/microl it was 0.34/PY, compared with 0.02/PY among those with CD4+ T-cell counts of > or =200/microl (P<0.0001). Risk factors for contralateral eye involvement included low CD4+ T-cell count and detectable CMV load. The overall rate of RD was 0.06/PY; among those with CD4+ T-cell counts of <50/microl it was 0.30/PY, compared with 0.02/PY among those with CD4+ T-cell counts of > or =200/microl (P<0.0001). Risk factors for RD included a low CD4+ T-cell count and larger area of CMV retinitis.
Conclusions: Compared with the rates reported in the pre-HAART era of second eye involvement (approximately 0.40/PY) and RD (approximately 0.50/PY), the rates of these events were reduced among patients in the HAART era. However, among patients with CD4+ T-cell counts of <50/microl, the rates were more similar to those from the pre-HAART era.