AIM: To investigate the fundus manifestations and human immunodeficiency virus (HIV) viral loads of acquired immune deficiency syndrome (AIDS) patients before and after highly active antiretroviral therapy (HAART). METHODS: This retrospective study included 21 AIDS patients (42 eyes) who presented to the Department of Ophthalmology, Peking Union Medical College Hospital, from 2007 to 2011. Among the patients, 16 showed a good response to HAART, 3 presented drug resistance and 2 were pre-HAART. All patients underwent comprehensive ophthalmic examinations. The HIV viral loads and the CD4(+) T-cell counts were also determined. RESULTS: The best-corrected visual acuity (BCVA) of 38 eyes (19 patients) was improved, and cytomegalovirus retinitis (CMVR) in 5 eyes (3 patients) regressed after HAART. Furthermore, 16 patients treated with effective HAART had decreased plasma HIV viral loads (<78 copies/mL) and increased CD4(+) T-cell counts (343 +/- 161 cells/mu L, P<0.005), but the HIV viral load in tears was still detected at 2404 copies/mL. The CD4(+) T-cell count was lower in the CMVR group than in the non-CMVR group (P=0.022), but the HIV viral load in the tears was not significantly different between the two groups (P=0.439). CONCLUSION: Most patients with AIDS show a good viral response with a decreased HIV viral load and an increased CD4(+) T-cell count in plasma after HAART. However, the HIV viral load remain quite high in the tear samples. Based on our results, we suggest that AIDS patients undergo long-term HAART that should not be interrupted.