The Adult Antiretroviral Treatment and Resistance Study (Tshepo)

NCT00197613 | Completed Phase 3 DMC

• 1 other identifier: HSC #0110THEA
• Study Type: interventional
• Target: 650
• Locations: 1 country
• Sites: 1

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 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.

Conditions

AIDS; HIV Infection

Outcome Measures

Primary Outcomes (1)

• Time to Virological failure, time to grade 3 or higher toxicity.

Secondary Outcomes (1)

• Time to drug resistance, rates of point mutations at virological failure, adherence to study medication.

Interventions

(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 DRUG

Adherence Strategy Standard of Care (SOC) PROCEDURE

Adherence Strategy Community-Based DOT PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Princess Marina Hospital, Botswana: collaborator
• Botswana Ministry of Health: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Princess Marina Hospital

Gaborone, Botswana

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; HIV Infections

Interventions

Zidovudine; Lamivudine; Nevirapine; efavirenz; Didanosine; Fumigant 93; Stavudine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dideoxynucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Zalcitabine; Deoxycytidine; Cytidine; Pyridines; Inosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ribonucleosides

Study Officials

• Richard Marlink, MD

  Harvard School of Public Health AIDS Initiative

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Practice of Public Health

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 20, 2005
• Study Start: December 1, 2002
• Study Completion: December 1, 2007
• Last Updated: September 17, 2012

Record last verified: 2012-09

Locations

BO (1)