Background:  We examined therapy duration, rates of therapy change and discontinuation, reasons for therapy change and discontinuation, clinical loss to follow-up, and death among HIV⁺ individuals on fixed-dose combination ART at a large HIV clinic in Southwestern Uganda.  
Methods:  We conducted a retrospective chart review of the first 500 patients initiating self-pay, fixed-dose combination stavudine/lamivudine/nevirapine (d4T/3TC/NVP) between January 1, 2001 and December 31, 2003. We assessed outcomes through May 31, 2005 using a standardized data abstraction form. We used Cox proportional hazards analysis to examine predictors of time to treatment discontinuation.

Results:  We followed 500 ART-naïve patients for a median of 21.5 months of whom 70.8% (354 patients) were World Health Organization (WHO) Stage 3 and 24.0% (120 patients) were WHO Stage 4. Among 410 patients (81.8%) with baseline CD4 testing, the mean CD4 count was 98.1±106.6. Median duration of therapy was 18.0 months ±18.0. At 12 months, 315 patients (63.0%) remained on their initial regimen, while 19 (3.8%) had changed regimens, 25 (5.0%) had documented treatment discontinuation, 104 (20.8%) were lost to follow-up, and 32 (6.4%) had documented deaths. During follow-up, 33 patients (6.6%) changed their ART regimen, 36.3% due to interaction with TB therapy and 15.2% due to suspected treatment failure; while 31 patients (6.2%) discontinued therapy, 45.0% due to concurrent TB therapy, and 42.0% due to cost. Among those citing interaction with TB therapy as the reason for change or discontinuation, the majority changed their antiretroviral regimen (58.3%) or discontinued therapy (57.1%) within the first 3 months after initiating antiretroviral therapy. Adjusting for baseline demographic and medical characteristics, baseline weight (HR 0.977/kg, 95%CI 0.954 to 1.000), chronic diarrhea (HR 2.798, 95%CI 1.324 to 5.910), and having children (HR 0.480, 95%CI 0.244 to 0.944) were significantly associated with treatment discontinuation.  
Conclusions:  Among ART-naïve, HIV⁺ persons receiving self-pay, fixed-dose generic d4T, 3TC, and NVP in southwestern Uganda, interaction with anti-TB therapy and cost are primary reasons for regimen change and treatment discontinuation. Low weight and chronic diarrhea increase the hazards while having children decreases the hazards of treatment discontinuation. Loss to follow-up is an important obstacle to monitoring outcomes.