Status:
COMPLETED
The Adult Antiretroviral Treatment and Resistance Study (Tshepo)
Lead Sponsor:
Harvard School of Public Health (HSPH)
Collaborating Sponsors:
Princess Marina Hospital, Botswana
Botswana Ministry of Health
Conditions:
AIDS
HIV Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 infectio...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00197613
Start Date
December 1 2002
End Date
December 1 2007
Last Update
September 17 2012
Active Locations (1)
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1
Princess Marina Hospital
Gaborone, Botswana