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The Adult Antiretroviral Treatment and Resistance Study (Tshepo)
This study has been completed.
Sponsor:
Harvard School of Public Health
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| 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 | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | The Adult Antiretroviral Treatment and Resistance Study (Tshepo) |
Resource links provided by NLM:
Further study details as provided by Richard Marlink, Harvard School of Public Health:
Primary Outcome Measures:
- Time to Virological failure, time to grade 3 or higher toxicity.
Secondary Outcome Measures:
- Time to drug resistance, rates of point mutations at virological failure, adherence to study medication.
| Estimated Enrollment: | 650 |
| Study Start Date: | December 2002 |
| Study Completion Date: | December 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00197613
Please refer to this study by its ClinicalTrials.gov identifier: NCT00197613
Locations
| Botswana | |
| Princess Marina Hospital | |
| Gaborone, Botswana | |
Sponsors and Collaborators
Harvard School of Public Health
Princess Marina Hospital, Botswana
Botswana Ministry of Health
McGill University Health Center
Bristol-Myers Squibb
Investigators
| Principal Investigator: | Richard Marlink, MD | Harvard School of Public Health AIDS Initiative |
More Information
| Responsible Party: | Richard Marlink, Professor of the Practice of Public Health, Harvard School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00197613 History of Changes |
| Other Study ID Numbers: |
HSC #0110THEA |
| Study First Received: | September 12, 2005 |
| Last Updated: | September 14, 2012 |
Additional relevant MeSH terms:
|
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Zidovudine Stavudine Didanosine Efavirenz Lamivudine Nevirapine |
Antimetabolites Molecular Mechanisms of Pharmacological Action Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Anti-HIV Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP3A Inducers |
ClinicalTrials.gov processed this record on June 26, 2017