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admin | Category: Herpes Treatment Options | 09.05.2015
Over the past several years, there has been a welcome invigoration of the research effort to cure HIV infection. The conduct of clinical trials related to HIV cure research raises new issues that multiple stakeholders—regulatory agencies, scientists, biotech and pharmaceutical companies, HIV-positive people, activists, community advisory boards, and institutional review boards—are now beginning to discuss and address.
Discussions about informed consent in the context of HIV cure research dovetail with wider interest in evaluating how useful and understandable the process is for trial participants. Another potential issue is that the term cure research can lead to a problem known as therapeutic misconception—the desire to be cured might trump cautions pertaining to risk and lack of benefit.
In the absence of any chance of immediate benefit, altruism and the desire to contribute to the search for a cure can still be powerful motivating factors.
An online community survey of over 2,100 HIV-positive respondents conducted in late 2011 and early 2012 (83% were male, 73% were white, 65% were over 40 years of age, 94% were on ART, and 35% had previously participated in a clinical trial) indicated a high level of altruism regarding early-stage HIV cure research. Recent and ongoing clinical trials provide examples of the uncertainties and risks that can be associated with cure-related research.
The use of ART interruptions in cure-related research offers another example of the potential risks associated with trial participation. As a result of the data from SMART, HIV treatment guidelines explicitly caution against ART interruptions. Adults with HIV infection are not the only population being considered in cure research, and ethical and informed consent issues for studies involving infants and children are even more complex. In addition to risks and benefits, another challenge for the regulation of cure research is the selection of appropriate endpoints (the means of measuring the success or failure of an approach). As the HIV cure research effort continues to gain momentum, regulatory and ethical issues will need to be a continuing subject of discussion among all stakeholders.


The first well-documented HIV cure occurred in a now famous individual named Timothy Brown, and resulted from stem cell transplants (SCTs) that were required to treat concomitant acute myeloid leukemia. Understandably, there is a great deal of interest in trying to achieve similar outcomes in other HIV-positive people with cancer who require SCTs, but it’s important to note that there can be regulatory issues associated with these procedures. As with other regulatory issues pertaining to cure research, there is a need for a broader public discussion among stakeholders—in this case including experts in stem cell transplantation—about the appropriate guidelines for using this approach to try to cure HIV. The mainstream media has picked up on this development, and stories about putative or possible cures are appearing more frequently than in the past. In most cases, there will be risks but little or no possibility of benefit to an individual participant; rather, results from trials will inform and advance the scientific pursuit of a cure. In a survey of over 2,100 people with HIV that was conducted by David Evans from Project Inform and Nelson Vergel from the Program for Wellness Restoration, over half the respondents (55%) reported that the possibility of benefiting others would motivate them to join a trial even if there were some potential risks. A leading approach for awakening the latent HIV that persists despite ART is the administration of anticancer drugs called HDAC inhibitors. But if an experimental intervention aims to induce control of HIV off ART (or even to eliminate the virus), the only way of assessing effectiveness is to stop treatment. Currently, a protocol is being developed that intends to investigate whether an apparent cure of HIV in an infant in Mississippi can be repeated. The FDA has expressed a commitment to ongoing engagement on the subject, and a broader dialogue convened by the Forum for Collaborative HIV Research is due to get under way soon. Contrary to the impression conveyed by some of these stories, a cure is not likely to announce itself by leaping from a scientist’s test tube waving a flag of victory. One proposed approach is to monitor trial participants for viral-load rebound frequently, and restart ART as soon as HIV becomes detectable; this is almost certainly the best way of preventing the virus from provoking high levels of inflammation, but there still could be other concerns such as increasing the size of the HIV reservoir.


The goal is to identify 20 to 30 infants born to HIV-positive mothers who did not receive ART to prevent mother-to-child transmission, and administer a three-drug therapeutic regimen within 48 hours of birth (instead of the standard two-drug prophylactic approach) until HIV diagnosis is established by testing, which usually takes around seven days.
But for interventions designed to reduce the size of HIV reservoirs, selecting an appropriate endpoint is more challenging due to the difficulties of reliably documenting changes in levels of HIV that are extremely low to begin with.
Food and Drug Administration (FDA) hosted a one-day public event that sought community input on the regulation of HIV cure research.
A study by researchers at the HIV INSIGHT network has also suggested that informed consent could be improved by making it an ongoing process throughout a trial, rather than a one-off procedure at the start. Additional surveys are now being planned under the aegis of the International AIDS Society’s Towards an HIV Cure initiative.
Three clinical trials assessing the impact of HDAC inhibitors on HIV latency have been conducted to date, fortunately without any serious safety issues emerging. Treatment will then be continued for around three years in infants confirmed to be infected; at that point, if HIV can no longer be detected, ART will be interrupted to assess whether a cure has been achieved. Although a variety of tests for trace amounts of HIV are available, their reliability and comparability is only starting to be assessed, and as yet there is no universally accepted standard technique. Webcasts, slide presentations, and a full transcript are available (search “cure research” at fda.org). The research has demonstrated that the drugs may be able to activate latent HIV, at least in some infected cells, but no reduction in the overall size of the HIV reservoir has been documented among participants.



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