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.
Drug: (A) zidovudine, lamivudine and nevirapine
Drug: (B) zidovudine, lamivudine and efavirenz
Drug: (C) zidovudine, didanosine, and nevirapine
Drug: (D) zidovudine, didanosine, and efavirenz
Drug: (E) stavudine, lamivudine, and nevirapine
Drug: (F) stavudine, lamivudine and efavirenz
Procedure: Adherence Strategy Standard of Care (SOC)
Procedure: Adherence Strategy Community-Based DOT
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||The Adult Antiretroviral Treatment and Resistance Study (Tshepo)|
- Time to Virological failure, time to grade 3 or higher toxicity.
- Time to drug resistance, rates of point mutations at virological failure, adherence to study medication.
|Study Start Date:||December 2002|
|Study Completion Date:||December 2007|
|Princess Marina Hospital|
|Principal Investigator:||Richard Marlink, MD||Harvard School of Public Health AIDS Initiative|