At the recent International AIDS Conference in Toronto in July, a group of activists from ACT UP Paris, held a protest against a trial called the Development of Antiretroviral Therapy in Africa, otherwise known as the DART study. Paula Munderi, who is here today, is one of the investigators working on this key piece of research, which you have seen today has taught us a great deal already about using ART in Africa. The demonstration involved disrupting the speech of James Hakim, a researcher involved in a DART trial site in Zimbabwe. The protesters held up banners saying "Shame" while also demanding information about the deaths in the study information that has been readily available on the trial website since May 2006. Furthermore, they suggested that the scientists involved in the DART study put trial participants at risk of illness and/or death and made other charges of improper conduct against the DART investigators. A meeting between local activists and investigators in Kampala along with trial participants a few weeks ago made it clear that the "controversy" around DART was a manufactured one. Since these claims were "made in Paris", let’s talk about them.

Let me be clear – there is no evidence to support ACT UP Paris’ claims that the informed consent process did not offer adequate information to the participants on health risks associated with the study or that any participants are excluded from the offer for post-trial care. ACT UP Paris also either misunderstands or is willfully mischaracterizing some components of the study and the available research on structured treatment interruptions. The DART study does not deprive any participant of laboratory monitoring of their HIV infection. The trial is an investigation of laboratory monitoring vs. clinical monitoring in the management of antiretroviral therapy to see what is the most effective strategy for use in resource-poor settings where laboratory capacity is often minimal or nonexistent. However, participants in the "clinical monitoring" arm are indeed getting laboratory monitoring, except that the results are blinded for both the participant and their doctor until the study is concluded unless there are significant laboratory abnormalities that would require clinical intervention. There is also no correlation at all in the literature about low CD4 nadirs, structured treatment interruptions and increased risk of disease progression as ACT UP Paris suggests. In fact, two key studies, SMART, the largest treatment interruption study conducted to date (>5,000 participants), found no association between CD4 nadir and the increased relative risk of progression and death that was seen among people taking long ( 18 months) CD4-guided treatment interruptions. Likewise, in the ongoing Trivacan STI study in Cote D’Ivoire, there has been no association found between the increased risk of events and CD4 nadir. In a pamphlet on the trial, ACT UP Paris has also stated that there was a "1% death rate in the STI arm." This falsely suggests that there was excess mortality in the structured treatment interruption arm, when in fact there were 5/408 deaths in the STI arm and 4/405 deaths in the continuous therapy arm. Sadly, as we’ll hear later today, we’ve learned from research on STIs that this strategy probably won’t be useful for PLWHAs.

ACT UP Paris’ actions have been shameful, not James Hakim’s, Paula’s or the other investigators involved with this study. In fact, ACT UP Paris, despite their claims to be supporters of research, are turning out to be its worst enemies. They have shut down studies of tenofovir in Cameroon and maroviroc in Europe, based not on evidence, but on their own ideological assumptions, their willingness to accept unverified claims as fact, their ignorance about study design and conduct, and as my colleague Bob Huff has said, a inclination to put their own individual beliefs above a careful consideration of the specifics of the drugs and the science.