21st International AIDS Conference (AIDS 2016)


Personal Clinical Benefits in HIV Cure Trials: Unlikely But Motivating

August 17, 2016

Regulators and HIV cure researchers in the United States concur that early cure studies have little chance of conferring direct clinical benefits on volunteers, according to the results of in-depth interviews. But high proportions of U.S. HIV-positive survey respondents saw diverse clinical benefits -- as well as benefits to society and to science -- as factors that would motivate them to participate in cure studies, according to the study poster presented at AIDS 2016.

AIDS service organization workers and academic collaborators conducted an online cross-sectional survey of 400 HIV-positive adults in 38 U.S. states in September and October 2015. They also completed in-depth interviews with 36 HIV-positive people, researchers, bioethicists and members of institutional review boards and regulatory agencies to assess perceived benefits. The survey required respondents to rank the importance of factors that would motivate them to consider participating in HIV cure studies as very important, somewhat important, barely important, not important and don't know/not applicable. Most survey respondents, 77%, were men. The ethnically diverse group was 65% white, 17% African-American, 12% Hispanic, 2% Asian and 4% mixed race/ethnicity.

The three leading "very important" potential clinical benefits that would motivate people to enroll in cure studies were preserving the immune system's ability to fight HIV (92%), reducing HIV in reservoirs or the entire body (85%) and controlling viral load in the absence of treatment (84%). The three top "very important" potential personal benefit motivators were feeling good about contributing to HIV cure research (80%), gaining knowledge about one's own health or HIV (78%) and learning about new treatment options (77%). The leading "very important" potential social benefit motivators were helping find a cure for HIV (95%), helping other people with HIV in the future (90%) and contributing to scientific knowledge (88%).

Related: What Would an HIV Cure Mean for You?

During in-depth interviews, regulators and clinician-researchers agreed that early HIV cure trials are unlikely to provide direct clinical benefits to participants. These experts stressed that participants may perceive indirect benefits that motivate them to volunteer for cure studies. During these interviews, potential volunteers listed diverse motivating factors, including feeling empowered, reducing stigma, bolstering advocacy work and ensuring participation of under-represented populations.

The researchers who conducted the survey offered several recommendations, starting with the responsibility of researchers "to report the associated lack of clinical benefits in early-phase HIV cure studies." To that end, informed-consent forms should "clearly distinguish between benefits to society and benefits to participants." The survey team called for more empirical research on actual benefits of participating in cure studies.

Mark Mascolini writes about HIV infection.

Copyright © 2016 Remedy Health Media, LLC. All rights reserved.

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Reader Comments:

Comment by: Tom (Chicago) Sat., Aug. 20, 2016 at 10:38 pm UTC
Define "Personal Clinical Benefits".

Free Rx and labs are "benefits" that two-thirds of all HIV+ Americans are living without:

The whole point of cure studies is to find-out what specific quantitative and qualitative differences in the cells/plasma/blood/tissues/organs/microbiota of HIV+ versus HIV- patients. And, more specifically, track the differences between an HIV+ person who becomes sero-negative and one who a given study is attempting to transition from sero-positive to sero-negative.

Humans used herbs (Birch Polypore) for many millennia without knowing anything more than that it made them feel better (reduce fever, swelling, etc).

What would you say about healthy HIV+ patients transitioning to healthy HIV- patients without specific information on how to help sicker HIV+ patients make the transition? Often progress happens by accident, and it is left to others to figure-out what happened and how to repeat it.

Although the first law of medicine is: 'First do no harm', when an epidemic strikes, and tems of millions of lives are at stake, and capitalism is more concerned about taking financial advantage of the epidemic - as opposed to ending it - truth (altruism) will become a casualty.

Thomas C. Merigan, Jr. MD, Stanford University School of Medicine, who ran the first study of AZT in humans, was told by Burroughs Wellcome that he should NOT submit Adverse Event Reports on patients who died of congestive heart failure from high doses of AZT. The patients were mostly obese women.

In an epidemic "First do no harm" sometimes becomes "First do something... anything... amd make progress by learning from your mistakes - if you have to!"

Do you hold the same cautionary standard for hepatitis-C cure studies?

Is the only difference between the two the fact that hepatitis-C can be nearly universally cured and HIV can't?
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Comment by: Tom (Chicago) Thu., Aug. 18, 2016 at 9:43 pm UTC
Your article needs to separate-out late treated individuals in poor health, who continue to abuse their body, from early treated individuals in good health with healthy lifestyles. Why? Because START has already confirmed multiple benefits to starting treatment early AND because a healthy lifestyle is necessary to help your body cure/repair/heal itself.

It's too late to 'pull the "AIDS Activist" Genie out of the bottle' regarding the Visconti cohort, Timothy Ray Brown, and (now) the French teenager:

Your article isn't clear on whether future cure studies will include free study drugs? You claimed to have talked with "regulators and clinician-researchers". Did any of them mention whether or not any cure studies might (or would) include the latest "standard of care" treatment regimen? If so, there would be a very high likelihood that that benefit would help an uninsured early treated HIV+ patient get back on his/her feet again. As many companies tend to lay-off HIV+ individuals because of their high health care costs. Yes, it still happens today. And there is nothing that can be done about it in an "at will" state.
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