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The Adult Antiretroviral Treatment and Resistance Study (Tshepo)

NCT ID: NCT00197613

Last Updated: 2012-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

650 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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AIDS HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Interventions

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(A) zidovudine, lamivudine and nevirapine

Intervention Type DRUG

(B) zidovudine, lamivudine and efavirenz

Intervention Type DRUG

(C) zidovudine, didanosine, and nevirapine

Intervention Type DRUG

(D) zidovudine, didanosine, and efavirenz

Intervention Type DRUG

(E) stavudine, lamivudine, and nevirapine

Intervention Type DRUG

(F) stavudine, lamivudine and efavirenz

Intervention Type DRUG

Adherence Strategy Standard of Care (SOC)

Intervention Type PROCEDURE

Adherence Strategy Community-Based DOT

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Princess Marina Hospital, Botswana

UNKNOWN

Sponsor Role collaborator

Botswana Ministry of Health

OTHER_GOV

Sponsor Role collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role lead

Responsible Party

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Richard Marlink

Professor of the Practice of Public Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Marlink, MD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health AIDS Initiative

Locations

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Princess Marina Hospital

Gaborone, , Botswana

Site Status

Countries

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Botswana

Other Identifiers

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HSC #0110THEA

Identifier Type: -

Identifier Source: org_study_id