International AIDS Society Newsletter, no. 21

IAS-Clinical Trials Partnership (IAS-CTP)
Meetings in Seattle during the 9th Conference on Retroviruses
and Opportunistic Infections

IAS-CTP Seattle Update Meeting: HIV Research
& Training in Resource-Constrained Countries
Prior to the opening ceremony for the 9th
Conference on Retroviruses and Opportunistic
Infections (CROI) in Seattle, Washington on
February 24th, the IAS-CTP held an afternoon-long meeting to update researchers and
investigators on IAS-CTP activities and current issues, initiatives effecting research and
training programs in resource-constrained
countries.
IAS-CTP Director, Professor Joep Lange
welcomed over 100 participants representing
twenty countries to the meeting that was cochaired by Helene Gayle (Bill and Melinda
Gates Foundation), Souleymane Mboup
(African AIDS Research Network), Elly
Katabira (Mulago Hospital, Kampala), and
Michel Kazatchkine (Agence Nationale de
Recherches sur le Sida, ANRS).
Clinical Trials Inventory
Kevin Frost and Virginia Differding presented
information on a collaborative project between
IAS-CTP and amfAR that has been established
to assemble and present international clinical
trials information on both the amfAR and IAS
websites. All international investigators are
being asked to submit protocol information for
current clinical trials. The information gathered will be entered into a searchable database
(i.e. country, protocol, condition, drug class)
that can be accessed by all interested parties.
IAS-CTP will take care of clinical trials in
developing countries. In the discussion following, Dr. Michel Kazatchkine noted that it
would be extremely useful if the inventory
could also be presented in other languages than
English.
Education and Tranining Programs
An update on IAS-CTP training initiatives
was given by Concepta Merry and Yasmin

Halima, and Jose Zuniga reported on the
GALEN program sponsored by IAPAC. IASCTP is currently working to develop standard
training models and assemble slide sets that
can be downloaded from the Internet and
utilised for training in developing countries.
In the discussion period that followed, Dr. Elly
Katabira announced that the Academic
Alliance for AIDS Care and Prevention in
Africa (launched in Uganda) would also be
providing training for health care workers
within the region.
Development of Ethical Frameworks for
Research and Treatment Access
A presentation on developing ethical frameworks for research and treatment access was
given by Ezekiel Emanuel of the NIH and
Basil Vareldzis of WHO. Dr. Emanuel outlined an approach developed by the NIH for
evaluating multinational clinical research that
includes the principles of collaborative partnership; social value; scientific validity; fair
selection of study population; favourable riskbenefit ratio; independent review; informed
consent; and respect for recruited study populations. Under each of these principles are
benchmarks and specific criteria that can be
used by investigators and sponsors in developing clinical trials.
Dr. Vareldzis made the point that recent
ethical/IRB requirements developed in the
North may limit the ability to conduct much
needed research in the South. Further, that
requirements for human subjects' protection
need to take into consideration differences in
cultures, as well as resource constraints and the
potential value of the research in different settings. WHO is proposing collaboration with
all stakeholders to address bioethical dilemmas
and develop a coordinated international
response. Needed steps towards this end were
then outlined by Dr. Vareldzis, including devel
opment of an ethics curricula for health professionals and an international code of practice.
Pharmacoeconomics and Pharmacokinetics
of HIVin Developing Countries
David Back (University of Liverpool), Concepta
Merry (St. James Hospital, Dublin), and Mairin
Ryan (National Pharmacoeconomic Center,
Dublin) presented on pharmacoeconomics
(PE) and pharmacokinetics (PK) of HIV in
developing nations. Terms and techniques
in pharmacoeconomics were defined with
examples, including models to determine cost
effectiveness of alternative interventions for
MTCT and the cost-effectiveness of HAART
in developing countries. Pharmacoeconomic
modelling can be utilised by governments and
multinationals in developing countries to
make decisions on treatment and to address
sustainability issues.
Given the differences among populations in
terms of behaviour, environment, genomics,
and viral issues, pharmacokinetic research is
needed to ensure efficacy and safety levels.
Significant interpatient and intrapatient variability in plasma drug levels has been noted for
both protease inhibitors and non-nucleoside
reverse transcriptase inhibitors. Ethnicity is an
important demographic determinant of drug
metabolism as the intrinsic variability in plasma antiretroviral drug levels is further
increased by behavioral, environmental, and
genomic factors. The presentation highlighted
the emerging role for PK and PE evaluation in
assisting healthcare decision-makers with budget allocative decisions now that the provision
of antiretroviral therapy in the developing
world appears feasible. The point was stressed
that both PE and PK research should be done
in tandem with clinical trials in developing
world countries.
(cont'd)

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