Before December 1997, in Espirito Santo, Brazil, combination antiretroviral
therapy was used without routine virologic or immunologic monitoring. To e
xamine consequences of therapy in this setting, clinical information, human
immunodeficiency virus type 1 (HIV-1) RNA levels, CD4 cell counts, and pro
tease and reverse transcriptase sequences were determined for consecutive H
IV-1-infected outpatients. Of 48 treatment-naive individuals, 11 were start
ed on therapy for HIV-related symptoms; however, 44 (92%) had an RNA level
>20,000 copies/mL, a CD4 cell count <500/mm(3), or symptoms, Eighteen (51%)
of 35 patients on therapy had an RNA level >20,000 copies/mL. Nucleoside-r
esistance mutations were observed in 21 (68%) of 31 nucleoside-experienced
subjects. Protease mutations necessary for high-level protease inhibitor (P
I) resistance were present together with permissive mutations in 3 of 10 PI
-experienced patients. Inability to identify high-risk individuals and to d
etect virologic failure may limit the effectiveness of antiretroviral drug
programs and may promote the spread of drug resistance where virologic and
immunologic monitoring are not available.