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DART

DART. The DART Trial. Evaluates two strategies for delivering ART , comparing:. clinical monitoring only with routine laboratory + clinical monitoring structured treatment interruptions with continuous ART. DART. Trial features I. 5 year trial 3 sites: Harare, Kampala, Entebbe

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DART

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  1. DART The DART Trial Evaluates two strategies for delivering ART, comparing: • clinical monitoring onlywith routine laboratory + clinical monitoring • structured treatment interruptionswith continuous ART

  2. DART 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

  3. DART DART Entebbe • Collaboration with TASO and Entebbe Hospital • DART Clinic at Entebbe Hospital – MOH • Care services: • Counseling • Diagnosis of HIV related illness & OIs • Treatment of HIV related illness & OIs • Antiretroviral therapy & monitoring • Psychosocial support

  4. DART Funding Sources • Medical Research Council, UK • Rockefeller Foundation, USA • Department for International Development, UK • Rock House Foundation, UK

  5. DART Drugs • Anti-retroviral drugs donated by • Boehringer-Ingelheim - Nevirapine • Gilead - Tenofovir • GlaxoSmithKline - Combivir

  6. DART 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

  7. DART Trial Approval • UVRI Science & Ethics Committee • Uganda National Council for Science & Technology - granted research clearance • Ethics committees in Zimbabwe & UK • Support letter from MOH

  8. DART 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

  9. 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 Plus Dr Dorothy Bray - Consultant Dr Alex Coutinho - TASO Uganda DART International Coordinating Group

  10. DART Other ART Trials in Uganda 1992 JCRC Determining the lowest effective dose of AZT 16 weeks duration 1 yr therapy to participants post trial

  11. DART Other Trials……………. 2002 Care project ( Pharmaccess, GSK, Roche ) Uganda, Kenya, Senegal, Cote d’Ivoire Response, Side effects, Education & adherence 200 participants total, 50 in each country Will provide ART to participants post trial

  12. DART Other Trials…………….. 2003 JCRC - NIH Evaluation of short STI strategies ( 7 days on 7 days off / Weekend off ) 171 participants to date Clinical follow up and monitoring provided Patients pay for own ART but save on drug cost ( 50% 7 days ; 30% weekend)

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