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| Sponsors and Collaborators: |
Harvard School of Public Health Princess Marina Hospital, Botswana Botswana Ministry of Health McGill University Health Center Bristol-Myers Squibb |
|---|---|
| Information provided by: | Harvard School of Public Health |
| ClinicalTrials.gov Identifier: | NCT00197613 |
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 |
|---|---|---|
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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 III |
| Study Type: | Interventional |
| Study Design: | Randomized, Open Label, Active Control, Parallel Assignment |
| Estimated Enrollment: | 650 |
| Study Start Date: | December 2002 |
| Estimated Study Completion Date: | December 2007 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Botswana | |
| Princess Marina Hospital | |
| Gaborone, Botswana | |
| Principal Investigator: | Richard Marlink, MD | Harvard School of Public Health AIDS Initiative |
More Information
| Study ID Numbers: | HSC #0110THEA |
| Study First Received: | September 12, 2005 |
| Last Updated: | April 3, 2007 |
| ClinicalTrials.gov Identifier: | NCT00197613 History of Changes |
| Health Authority: | Botswana: Ministry of Health |
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Antimetabolites Anti-Infective Agents Efavirenz Sexually Transmitted Diseases, Viral Anti-HIV Agents Stavudine Acquired Immunodeficiency Syndrome Zidovudine Lamivudine Antiviral Agents |
Immunologic Deficiency Syndromes Reverse Transcriptase Inhibitors Virus Diseases Nevirapine Didanosine Anti-Retroviral Agents HIV Infections Sexually Transmitted Diseases Retroviridae Infections |
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Antimetabolites Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Stavudine Molecular Mechanisms of Pharmacological Action Zidovudine Lamivudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Retroviridae Infections Nucleic Acid Synthesis Inhibitors Efavirenz |
RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Enzyme Inhibitors Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Nevirapine Didanosine HIV Infections Sexually Transmitted Diseases Lentivirus Infections |
