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START Newsletter The Strategic Timing of AntiRetroviral Treatment – An INSIGHT Trial
February 2011
International Network for Strategic Initiatives in Global HIV Trials
SDMC: [email protected]
London ICC: [email protected] Washington ICC: [email protected]
Sydney ICC: [email protected] Copenhagen ICC: [email protected]
START
ONWARDS AND UPWARDS
The 1000th
patient was recruited on the 25th
of
December 2010 and as of the 31st
January 2011, 1076
patients have been recruited across the open sites.
Table 1 below shows the recruitment summary by
country (as of 31st
January 2011) and the number of
sites currently recruiting in each country.
Table 1: Recruitment Summary by Country (31-Jan-11)
Country No. of patients
recruited
No. of sites in
country
USA 168 25 sites
Germany 167 17 sites
Spain 74 5 sites
France 68 11 sites
UK 61 5 sites
Argentina 61 7 sites
Brazil 57 2 sites
Thailand 52 2 sites
Belgium 47 2 sites
South Africa 43 1 site
Peru 42 3 sites
Australia 41 6 sites
Poland 32 1 site
Greece 27 3 sites
Chile 24 1 site
Mali 23 1 site
Denmark 23 2 sites
Morocco 16 1 site
Switzerland 16 3 sites
Finland 14 1 site
Italy 11 1 site
Israel 9 1 site
Figure 1: Current START Countries
Recruitment figures vary widely within each country and we
would like to thank all sites for their hard work so far and to
stress how important it is to keep recruitment at the same or
improved level. We would also like to especially congratulate
the top ten recruiting sites for this study. Our thanks go to:
1. Desmond Tutu HIV Foundation, South Africa 43 patients
2. Hospital Escola Sao Francisco de Assis, Brazil 40 patients
3.= Asociacion Civil IMpactat Salud y Educacion,
Peru
32 patients
3.= Chulalongkorn University Hospital, Thailand 32 patients
3.= Wojewodzki Szpial Zakazny, Poland 32 patients
6. Johann Wolfgang Goethe University Hospital,
Germany
26 patients
7.= Fundacion Arriaran, Chile 25 patients
7.= Hopital Saint-Louis, France 25 patients
7.= Institute of Tropical Medicine, Belgium 25 patients
10. Klinik fuer Innere Medizin der Universitaet
Koeln, Germany
24 patients
The successful recruitment at pilot sites has resulted in DAIDS
giving the go-ahead for the definitive phase of START. The main
study aims to recruit 4000 patients across all sites and with
current recruitment projections the study is expected to be fully
recruited before the end of 2012.
START EXPANSION PLANS
A further 137 sites have recently been approved for
participation in START, bringing the total number of START sites
to 238. Most new sites are located in countries already
participating in START, but some sites are in countries that are
new to this study including Austria, Czech Republic, Estonia,
Luxembourg, Norway, Portugal, Sweden, Uganda, Nigeria,
Ireland, India, Malaysia, Singapore, Mexico and Puerto Rico. An
overview of all countries with sites participating in START is
given in Figure 1, Current START Countries.
START Newsletter The Strategic Timing of AntiRetroviral Treatment – An INSIGHT Trial
February 2011
International Network for Strategic Initiatives in Global HIV Trials
SDMC: [email protected]
London ICC: [email protected] Washington ICC: [email protected]
Sydney ICC: [email protected] Copenhagen ICC: [email protected]
START
CENTRAL DRUG REPOSITORY (CDR)
The INSIGHT network provides free study drugs for
patients enrolled into START, however, only
antiretrovirals that are approved and available within
a country can be obtained via the CDR.
All initial regimens should be prescribed according to
the document titled Antiretroviral Components
Required for Initial Regimen in START which is
available on the INSIGHT website and can be accessed
as follows:
Member log in -> HIV studies -> START -> Protocol
Materials -> Drug Management
The CDR is updated on a yearly basis following the
process outlined below:
1. Updating of the Clinical Trial Agreements (CTAs)
between Pharma and the Sponsor; this is
currently ongoing for the definitive phase.
2. Approval and printing of START drug labels; the
labels have recently been approved in all START
countries and are currently being printed.
3. Shipment of drugs to the repositories, ready for
order and shipment to sites.
Table 2 summarizes projected dates when drugs will
be available.
Table 2: Projected Drug Availability at Sites
Date New Site New Country* Drug
May 2011 No No New Drug(s)
May 2011 Yes No All Drugs
July 2011 Yes Yes All Drugs
* These countries did not participate in the pilot phase of START.
Please do not hesitate to contact your SCC or ICC if
you have any questions with regard to drug
availability. We are happy to help.
SUBSTUDIES OF START
START provides an excellent opportunity to gain more
detailed information about the impact of HIV and ART
on other body systems. Hence, a number of substudies
have been developed, including:
- The Arterial Elasticity (AE) Substudy
- The Pulmonary Substudy
- The Bone Mineral Density (BMD) Substudy
- The Neurology Substudy
- The Genomics Substudy
- The Informed Consent Substudy
Details about the different substudies can be found on
the INSIGHT website as follows:
Member log in -> HIV studies -> START -> Substudies
SUBSTUDY ENROLMENT
While most sites have managed to co-enroll the majority of
their patients into the Genomics Substudy, enrolment into the
Arterial Elasticity, Pulmonary and Neurology Substudies has
proven more difficult than anticipated. The substudies will all
provide important data on the START participants and we
would encourage all sites to continue with their efforts to co-
enroll as many participants as possible.
Some sites have done exceedingly well and after substudy
opening have managed to co-enroll 100% of their patients in
one or more of these substudies. These sites are as follows:
- Hospital Rawson, Argentina
- St. Vincent’s Hospital, Australia
- Centre Hospitalier Universitaire St. Pierre, Belgium
- Asklepios Klini St. Georg, Germany
- Gemeinschaftspraxis Jessen-Jessen- Stein, Germany
- Infectious Diseases and Pneumology Klinikum Dortmund,
Germany
- Universitaetsklinikum Erlangen, Germany
- Hospital Nacional Guillermo Almenara Irigoyen, Peru
- Universitatsklinik fur Infektologie, Switzerland
- Bronx-Lebanon Hospital Centre CRS, USA
- Henry Ford Hospital CRS, USA
- Minneapolis Medical Research Foundation, USA
- Naval Medical Centre San Diego, USA
- Temple University, USA
- Virginia Commonwealth University Medical, USA
Congratulations to all of these sites for their great efforts!
UPCOMING MEETINGS
NEXT INSIGHT INVESTIGATOR MEETING
An INSIGHT investigator meeting is scheduled in conjunction
with CROI for Sunday, 27 February 2011, 13:00-15:30 at the
Omni Parker House Hotel in Boston, Massachusetts, USA. A
buffet lunch for INSIGHT Investigators will be served prior to
the meeting at 12:00 noon at the hotel. If you are attending
CROI and are able to attend this meeting, please register on the
INSIGHT webpage as follows:
Member log in -> INSIGHT Meetings -> Upcoming Meetings ->
Registration
We are looking forward to seeing you there!
Data and Safety Monitoring Board (DSMB) Meeting
The next DSMB meeting is scheduled for April 2011. This will be
a full review.