The Botswana Harvard AIDS Institute Partnership for HIV Research and Education: The Adult Antiretroviral Treatment and Resistance Study (Tshepo Study)

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Tshepo Study

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Tshepo Study: The Adult Antiretroviral Treatment and Resistance
The Tshepo Study ("Tshepo" means "hope" in Setswana) is the first large-scale research study that aims to assess the emergence of drug resistance to and the tolerability of different protease inhibitor sparing highly active anti-retroviral therapy (HAART) regimens. The study will also compare two different strategies to enhance patient adherence to these treatments in Botswana, a country where HIV-1 Subtype C is prevalent.

Patients enrolled in the study will be randomized to one of six highly-active ARV medication regimens (HAART). Patients will also be randomized to one of two adherence strategies: the standard of care (SOC) adherence strategy, compared to SOC strategy plus community-or family-based daily directly observed therapy (Com-DOT).

The eligibility criteria for participants are: 1) ART naïve; 2) at least 18 years old; 3) live within the city or outskirts of the study site, Gaborone and 4) do not require high level special care or assistance in their daily life (Karnofsky performance score equal or greater to 50).

Primary study objectives:

Compare the time to virological failure with significant drug resistance by type of NRTI combination, type of NNRTI, and by type of adherence strategy in this population where HIV-1C is prevalent.

Compare the time to development of treatment-related toxicity, as defined by first instance of a grade 3 or greater event, by treatment and by adherence strategy.
Characterize phenotypic drug resistance in relation to findings concerning genotypic patterns of resistance.
Compare monthly assessments of whether participants have taken greater than or equal to 90% of required study medications by type of adherence strategy and by treatment regimen.
Compare treatment outcome for two different CD4 treatment initiation strata, namely participants whose CD4 at enrolment is below 200 cells/microliter and those whose CD4 is between 201 and 350 cells/microliter (with a plasma viral load of > 55,000 copies/mL).
To compare health research use, productivity, and quality of life by treatment and adherence strategy as part of a larger cost-effectiveness study.

The study officially opened for randomization in December 2002. The study is expected to meet its target enrollment of 650 patients within 12 to 15 months. The study is being conducted at the outpatient Infectious Disease Care Clinic of Princess Marina Hospital (the referral hospital for southern Botswana) located in the capital city of Gaborone.

The Tshepo Study is funded by the Bristol Myers Squibb, "Secure the Future" Foundation.