Archive for December 9, 2005

Education and debate – Designing research in vulnerable populations: lessons from HIV prevention trials that stopped early

Source: British Medical Journal 10 Dec. 2005 vol.331 p.1403-1406

Edward J Mills, fellow1, Sonal Singh, assistant professor2, Jerome A Singh, head of bioethics and health law programme3, James J Orbinski, associate professor4, Mitchell Warren, executive director5, Ross E Upshur, associate professor6

1 Department of Clinical Epidemiology and Biostatistics, McMaster University, HSC-2C12, 1200 Main Street West, Hamilton, ON, Canada L8N 3Z5, 2 Department of Medicine, Wake Forest University, North Carolina, USA, 3 Centre for the AIDS Programme of Research in South Africa and Howard College School of Law, University of KwaZulu-Natal, Durban, South Africa, 4 St Michael’s Hospital, University of Toronto, Toronto, Canada, 5 AIDS Vaccine Advocacy Coalition, New York, USA, 6 Joint Centre for Bioethics, University of Toronto, Toronto, Canada

Correspondence to: E J Mills millsej@mcmaster.ca

Activist groups have been successful in promoting research and better treatment for people with HIV infection, but they can also stop trials if their views are not considered

Introduction

Methods to prevent HIV infection are one of the most urgent global public health needs.1 One novel method in clinical trials is pre-exposure prophylaxis with the antiretroviral drug tenofovir. The trials have, however, been criticised by activist groups, citing human rights, ethical concerns, and a lack of community involvement.2 This opposition and media coverage has stopped two trials in Cambodia and Cameroon and threatens the stability of planned and recruiting trials among intravenous drug users in Thailand and other developing nations. The issues raised by activists, academics, and the research community highlight the poor communication between these stakeholders and the need for mutual understanding of values. The differences threaten to undermine the progress of prevention trials and ultimately affect the most important stakeholders, those who are at risk.3 ……

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December 9, 2005 at 11:03 am Leave a comment

Paper – Time trends in primary resistance to HIV drugs in the United Kingdom: multicentre observational study

Source: British Medical Journal 10 Dec. 2005 voo. 331 p.1368

UK Group on Transmitted HIV Drug Resistance

Correspondence to: D Dunn, Senior scientist, Medical Research Centre Clinical Trials Unit, London NW1 2DA d.dunn@ctu.mrc.ac.uk

Abstract

Objective To examine whether the level of primary resistance to HIV drugs is increasing in the United Kingdom.

Design Multicentre observational study.

Setting All virology laboratories in the United Kingdom carrying out tests for HIV resistance as part of routine clinical care.

Participants 2357 people infected with HIV who were tested for resistance before receiving antiretroviral therapy.

Main outcome measure Prevalence of drug resistance on basis of the Stanford genotypic interpretation system.

Results Over the study period (February 1996 to May 2003), 335 (14.2%, 95% confidence interval 12.8% to 15.7%) samples had mutations that conferred resistance to one or more antiretroviral drugs (9.3% high level resistance, 5.9% medium level resistance). The prevalence of primary resistance has increased markedly over time, although patterns are specific to drug class; the largest increase was for non-nucleoside reverse transcriptase inhibitors. In 2002-3, the prevalence of resistance to any antiretroviral drug to nucleoside or nucleotide reverse transcriptase inhibitors, to non-nucleoside reverse transcriptase inhibitors, or to protease inhibitors was 19.2% (15.7% to 23.2%), 12.4% (9.5% to 15.9%), 8.1% (5.8% to 11.1%), and 6.6% (4.4% to 9.3%), respectively. The risk of primary resistance was only weakly related to most demographic and clinical factors, including ethnicity and viral subtype.

Conclusions The United Kingdom has one of the highest reported rates of primary resistance to HIV drugs worldwide. Prevalence seems still to be increasing and is high in all demographic subgroups.

December 9, 2005 at 11:00 am Leave a comment


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