Volume 14, I – Spring 2005

A guideline for ethics in clinical trials in vulnerable populations

At a time when the need to test novel medication in HIV positive treatment naïve individuals is strong, and in which the ethical scrutiny in industrialised countries renders the conduction of such trials a complex and costly endeavour, resulting in an increased number of clinical trials in marginalized populations and resource poor countries, the EATG decided to convey its own perspective through a Position Paper on Ethics of Clinical Trials in vulnerable groups.

A new definition for professional disability, or professional disability from a gender perspective

Professional disability can appear in many forms and how and what is classified as disabling is very important. HIV can have many debilitating effects on people who live with it, and gender can play a key role in the frequency and intensity of these effects.

A slow symbolic step forward

The U.S. Food and Drug Agency (FDA) gave, for the first time, approval for a non U.S.-based generic antiretroviral drug; South African Aspen Pharmacare’s regimen of a generic version of GSK’s fixed-dose combination Combivir® packaged along with Boehringer Ingelheim’s Viramune® (nevirapine).

Community involvement in clinical trials: From the U.S. to Western Europe

Ever since people with AIDS demanded the right to ”be involved at every level of decision-making“ with the 1983 Denver Principles, [1] they have been traveling a long upward road towards control of their own lives.

EATG's position paper on ethics of clinical trials in vulnerable populations

Fundamental is the notion that some groups or countries are more vulnerable than others, for what concerns the participation in clinical trials, and need special protection.

Ensuring that HIV/AIDS is in the European Commission’s agenda

On December 8th, 2005, the EATG took the opportunity of the nomination of Mr Durão Barroso as President of the European Commission, to remind this institution that HIV/AIDS remains one of the most concerning health and development issue, notably in Eastern Europe and Central Asia, and that it is the responsibility of the European Union to tackle this situation and make it a priority in its agenda.

Ethics as borderline to science

Last April, the EATG, the organization that edits this magazine, published a press release in which they asked the European regulatory authorities to force modifications on the A4001026 trial by Pfizer or deny permission for its carrying out.

European activists demand regulatory agencies to halt unethical trial

Pfizer recruiting for phase II dose-finding trial for investigational compound offering no safety net: ”The trial design should be changed or otherwise stopped“, declares Mauro Guarinieri, Chairperson of the EATG.

Future directions project

The history of International AIDS Conferences started in Atlanta, in 1985, with a first small event. Organized annually (until Yokohama 1994), then bi-annually (since Vancouver 1996), this conference grew bigger and bigger with every edition, achieving a record number of registrations last year in Bangkok (19,843).

HIV-positive children in Romania: An interview with Dr. Rodica Matusa

Between 1989 and 2003 Dr. Rodica Matusa coordinated the paediatric care of HIV-positive children in the county of Constanta, situated in the south-eastern part of Romania.

Needed representation of HIV/AIDS community at the upcoming CND conference

The Commission on Narcotic Drugs (CND) is the central policy-making body within the United Nations and deals with drug-related issues.

Sex, drugs and super-virus

Last February’s announcement of the discovery of a new highly dangerous HIV super-strain injected fear throughout the HIV and gay communities.

TRT-5: French activists united

Created in 1992 and modeled after a U.S. model of activism, TRT-5 (Therapeutic Research and Treatment group) brought together at that moment 5 French organizations involved in the fight against AIDS: Actions Traitements, Act Up, Aides, Arcat Sida and Vaincre le Sida.

The nevirapine case

Widely used for many years for the treatment of HIV infection, the nonnucleoside analogue nevirapine (NVP; Viramune®) has in the last few months been the focus of several reports which could cause confusion.

The right to become a mother without getting HIV

When economic criteria are more important than the right to health care and ethics. Just before the last World AIDS Day, during the 7th edition of the Congress on HIV Pharmaceutical Therapies,
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