The Adult Antiretroviral Treatment and Resistance Study (Tshepo)

This study has been completed.
Sponsor:
Collaborators:
Princess Marina Hospital, Botswana
Botswana Ministry of Health
McGill University Health Center
Bristol-Myers Squibb
Information provided by (Responsible Party):
Richard Marlink, Harvard School of Public Health
ClinicalTrials.gov Identifier:
NCT00197613
First received: September 12, 2005
Last updated: September 14, 2012
Last verified: September 2012

September 12, 2005
September 14, 2012
December 2002
Not Provided
Time to Virological failure, time to grade 3 or higher toxicity.
Not Provided
Complete list of historical versions of study NCT00197613 on ClinicalTrials.gov Archive Site
Time to drug resistance, rates of point mutations at virological failure, adherence to study medication.
Not Provided
Not Provided
Not Provided
 
The Adult Antiretroviral Treatment and Resistance Study (Tshepo)
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • AIDS
  • HIV Infection
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
650
December 2007
Not Provided

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Botswana
 
NCT00197613
HSC #0110THEA
Yes
Richard Marlink, Harvard School of Public Health
Harvard School of Public Health
  • Princess Marina Hospital, Botswana
  • Botswana Ministry of Health
  • McGill University Health Center
  • Bristol-Myers Squibb
Principal Investigator: Richard Marlink, MD Harvard School of Public Health AIDS Initiative
Harvard School of Public Health
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP