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
  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 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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: Botswana: Ministry of Health

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Didanosine
Zidovudine
Stavudine
Nevirapine
Lamivudine
Efavirenz
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on August 18, 2014