The DART Trial Evaluates two strategies for delivering ART, comparing: clinical monitoring only with...
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The DART Trial
Evaluates two strategies for delivering ART, comparing:
• clinical monitoring onlywith routine laboratory + clinical monitoring
• structured treatment interruptionswith continuous ART
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Trial features I
• 5 year trial• 3 sites: Harare, Kampala, Entebbe• 3000 patients – 1000 at each site / 1 year
• Primary endpoints : Efficacy -progression to a new WHO stage 4 or death
Safety - new SAE which is not HIV related• Other outcomes: Adherence , Virological including resistance, Socioeconomic & behavioural impact
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DART Entebbe
• Collaboration with TASO and Entebbe Hospital• DART Clinic at Entebbe Hospital – MOH• Care services:
CounselingDiagnosis of HIV related illness & OIsTreatment of HIV related illness & OIsAntiretroviral therapy & monitoringPsychosocial support
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Funding Sources
• Medical Research Council, UK
• Rockefeller Foundation, USA
• Department for International Development, UK
• Rock House Foundation, UK
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Drugs
Anti-retroviral drugs donated by
• Boehringer-Ingelheim - Nevirapine
• Gilead - Tenofovir
• GlaxoSmithKline - Combivir
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Trial Review Process
2 yrs +
• Risk benefits fine• Most attention to end of trial issues• Concern about exclusion of pregnant women• ? What happens after patient 1000 - community• Very little discussion on ability of participants to
decline
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Trial Approval
• UVRI Science & Ethics Committee
• Uganda National Council for Science & Technology - granted research clearance
• Ethics committees in Zimbabwe & UK
• Support letter from MOH
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Trial Monitoring
• Trial Steering Committee• International Co-ordinating Group• Local Trial Management Committees• Analysis & Data Management Committee• Data & Safety Monitoring Committee• Pharmaceutical companies
- adverse events• End Point Review Committee
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International Coordinating Group
PI’s
Dr Peter Mugyenyi - Kampala
Prof Jimmy Whittworth - Entebbe
Prof Ahmed Latif - Zimbabwe
Prof James Hakim - Zimbabwe
Prof Janet Darbyshire - London
Prof Charles Gilks - Geneva
Site investigators
Dr Diana Gibb - London
Dr Andrew Reid - Zimbabwe
Dr Cissy Kityo - Kampala
Dr Paula Munderi - Entebbe
PlusDr Dorothy Bray - Consultant
Dr Alex Coutinho - TASO Uganda
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Other ART Trials in Uganda
1992
JCRCDetermining the lowest effective dose of AZT16 weeks duration1 yr therapy to participants post trial
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Other Trials…………….
2002
Care project ( Pharmaccess, GSK, Roche ) Uganda, Kenya, Senegal, Cote d’Ivoire
Response, Side effects, Education & adherence200 participants total, 50 in each countryWill provide ART to participants post trial
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Other Trials……………..
2003
JCRC - NIHEvaluation of short STI strategies
( 7 days on 7 days off / Weekend off )
171 participants to dateClinical follow up and monitoring providedPatients pay for own ART but save on drug cost
( 50% 7 days ; 30% weekend)