The Adult Antiretroviral Treatment and Resistance Study (Tshepo)

HIV Infection Clinical Trial

Official title:

The Adult Antiretroviral Treatment and Resistance Study (Tshepo)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00197613
• Other study ID #: HSC #0110THEA
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 14, 2012
• Start date: December 2002
• Est. completion date: December 2007

Study information

• Verified date: September 2012
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Botswana: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• AIDS
• HIV Infection

Intervention

Drug:
• (A) zidovudine, lamivudine and nevirapine

• (B) zidovudine, lamivudine and efavirenz

• (C) zidovudine, didanosine, and nevirapine

• (D) zidovudine, didanosine, and efavirenz

• (E) stavudine, lamivudine, and nevirapine

• (F) stavudine, lamivudine and efavirenz

Procedure:
• Adherence Strategy Standard of Care (SOC)

• Adherence Strategy Community-Based DOT

Locations

Country	Name	City	State
Botswana	Princess Marina Hospital	Gaborone

Sponsors (5)

Lead Sponsor	Collaborator
Harvard School of Public Health	Botswana Ministry of Health, Bristol-Myers Squibb, McGill University Health Center, Princess Marina Hospital, Botswana

Country where clinical trial is conducted

Botswana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Virological failure, time to grade 3 or higher toxicity.
Secondary	Time to drug resistance, rates of point mutations at virological failure, adherence to study medication.