The Adult Antiretroviral Treatment and Resistance Study (Tshepo)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00197613

Enrollment

650

Registered

2005-09-20

Start date

2002-12-31

Completion date

2007-12-31

Last updated

2012-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIDS, HIV Infection

Brief 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.

Interventions

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

PROCEDUREAdherence Strategy Standard of Care (SOC)

PROCEDUREAdherence Strategy Community-Based DOT

DRUG(A) zidovudine, lamivudine and nevirapine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Time to Virological failure, time to grade 3 or higher toxicity.	—

Secondary

Measure	Time frame
Time to drug resistance, rates of point mutations at virological failure, adherence to study medication.	—

Countries

Botswana

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026