Transcript The DART Trial

The DART Trial
Evaluates two strategies for delivering ART,
comparing:
• clinical monitoring only
with routine laboratory + clinical monitoring
• structured treatment interruptions
with continuous ART
Trial features I
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5 year trial
3 sites: Harare, Kampala, Entebbe
3000 patients – 1000 at each site / 1 year
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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:
Counseling
Diagnosis of HIV related illness & OIs
Treatment of HIV related illness & OIs
Antiretroviral therapy & monitoring
Psychosocial support
Funding Sources
• Medical Research Council, UK
• Rockefeller Foundation, USA
• Department for International Development, UK
• Rock House Foundation, UK
Drugs
Anti-retroviral drugs donated by
• Boehringer-Ingelheim - Nevirapine
• Gilead
- Tenofovir
• GlaxoSmithKline
- Combivir
Trial Review Process
2 yrs +
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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
Trial Approval
• UVRI Science & Ethics Committee
• Uganda National Council for Science &
Technology - granted research clearance
• Ethics committees in Zimbabwe & UK
• Support letter from MOH
Trial Monitoring
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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
International Coordinating Group
PI’s
Site investigators
Dr Peter Mugyenyi - Kampala
Prof Jimmy Whittworth - Entebbe
Prof Ahmed Latif - Zimbabwe
Prof James Hakim - Zimbabwe
Prof Janet Darbyshire - London
Prof Charles Gilks - Geneva
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
Other ART Trials in Uganda
1992
JCRC
Determining the lowest effective dose of AZT
16 weeks duration
1 yr therapy to participants post trial
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
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)