NCT00197613

The Adult Antiretroviral Treatment and Resistance Study (Tshepo)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 650 (planned)
• Sponsor: Harvard School of Public Health (HSPH) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• AIDS
• HIV Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2002-12-01
• Completion: 2007-12-01
• First posted: 2005-09-20
• Last updated: 2012-09-17

Locations

1 site across 1 country: Botswana