The Adult Antiretroviral Treatment and Resistance Study (Tshepo)
The Adult Antiretroviral Treatment and Resistance Study (Tshepo)
The "Adult Antiretroviral Treatment and Resistance Study," hereafter referred to as "The
 Tshepo Study," is the first large-scale research study of antiretroviral therapy to treat
 AIDS and HIV infection in Botswana. The Tshepo Study is an open-label, randomized study
 comparing: (1) the rate of development and specific types of drug resistance mutations with
 various antiretroviral combination therapies to HIV-1C, the subtype of HIV found in southern
 Africa, and (2) the short and long-term effectiveness of two operational modifications of
 Directly Observed Therapy (DOT) medication adherence strategies for antiretroviral therapy.
 Specifically, treatment follow-up via the Standard of Care, the national standard of care as
 it evolves in Botswana, with intensive clinic-based follow up including regular adherence
 education sessions, will be compared to Community-Based Directly Observed Therapy (Com-DOT).
 Com-DOT involves the SOC with added community or family-based DOT. This Com-DOT component
 would involve a trained, community or family-based Medication Partner ("mopati") who observes
 the patient take his or medications daily.
Inclusion Criteria:(1) HIV infection indicated by (a) positive ELISA in two separate blood
 samples, the second no more than eight weeks prior to randomization), (b) CD4 cell count of
 less than 200 cells/ml OR CD4 cell count between 201-350 with plasma HIV-1 RNA level of
 greater than 55,000 copies/ml, (c) Karnofsky (performance) score greater than or equal to
 50; (2) no history of previous antiretroviral therapy, except for zidovudine and/or
 single-dose nevirapine administered during pregnancy to prevent mother-to-child HIV
 transmission of HIV-1; (3) baseline hemoglobin of greater than or equal to 8.0 g/dl (4)
 baseline absolute neutrophil count greater than or equal to 1000 cells/mm3 (5) baseline
 serum creatinine level less than 200 micromol/L (6) baseline SGPT(ALT) less than 205 U/L
 and SGOT (AST) less than 170 U/L (7) baseline alkaline phosphatase level less than or equal
 to 330 U/L etc.