A significant proportion of people living with HIV would be willing to take part in a study towards a search for a cure for HIV infection, as presented in21ª International AIDS Conference (AIDS 2016)in Durban, South Africa last month.
However some potential participants may not fully understand that taking part in an early phase of a study is highly unlikely to lead to any personal clinical benefit, but may have the potential to cause serious damage.
"There is an ethical imperative to understand the motivations of the decision-making, expectations and understanding of potential participants in the trial," researchers say. Better community engagement and education seems to be necessary.
According to an Australian study, 82% of people living with HIV would be "willing" or "very willing" to participate in a clinical trial related to the search for a cure for HIV infection. However respondents would be less willing to participate if they knew:
- Would increase their susceptibility to disease (87%)
- They ventured to the development of cross-resistance to antiretroviral current (79%) existing.
- It resulted in an unexpected increase in viral load by up to one year (63%) or
- Who would be committed to the need for weekly visits to a medical clinic for several months (40%).
In contrast, 31% would be more willing to participate if it would help future generations would not provide personal benefits.
When asked about the possible features or benefits of a cure, respondents indicated that the most important thing was not to pass the virus to others. Very important, too, not be at risk of ill health due to advanced HIV disease.
Other results were classified inferiorly: stop the use of antiretroviral drugs, is considered a person without HIV infection, not contract HIV again for a second (recontamination editor's note can be disastrous in a successful treatment it can bring strains resistant to that treatment scheme ) time and fewer doctor visits.
More detailed findings came from a questionnaire completed by 400 Americans living with HIV, 77% of whom were male sex. Whereas 65% were white, 17% black, 12% Hispanic, 4% mixed and 2% Asian. Along with the survey, interviews were conducted with 36 people living with HIV, doctors, researchers, bioethicists and regulators. The results were reported in a series of posters.
According to data that came from Australia of a general survey of people living with HIV covering a wide range of issues, the American participants were connected to research networks for the cure of HIV were recruited for a survey of this healing. They could expect to be better informed about the healing issues and more interested in participating in a healing study.
Nevertheless, 8% believe that the cure for HIV already exists. More than 27% of think that healing will probably be available within five years and 33% think they would still need to wait for further ten years. (The author of this blog reserves the right to say they do not think about healing and living one day at a time and, contradictorily, makes plans twenty-five years in the future (...) ...)
Asked about the potential benefits of taking part in research related to healing, the benefits to society in general were highly classified. Help find a cure for HIV (95%), help others with HIV in the future (90%) and contribute to scientific knowledge (88%) were among the most cited reasons.
Tais besocial efits could have an emotional impact - "the pleasant feeling of having contributed, in one way or another, to the search for a cure for HIV" was an important personal benefit (80%). Respondents also hoped to gain knowledge about their own health or HIV (78%) and new treatment options (77%). Get better access to medical care was cited by a number of participants, but few were motivated by financial compensation.
In terms of clinical benefits, many respondents expressed the hope that they can increase the ability of your immune system to fight HIV (92%), reduce the reservoir of HIV in your body (85%), the load control viral in the absence of treatment (84%) or reduce the risk of transmitting the virus to a sexual partner (79%).
However the researchers commented that the "early stage of the investigation does not confer designed clinical benefits directly and there is the possibility of damage while advancing medical knowledge."
Research has shown that participants are less aware of the risks than benefits. Inquiring about those potential risks that dissuade to participate in a study related to the cure of HIV, respondents indicated a number of possible damage, but in smaller numbers.
In terms of clinical risk, cancer risk increased (49%), the development of resistance to antiretroviral drugs (37%), side effects (30%) and the known risks of stopping the HIV drugs (30%) could discourage participation.
study procedures presenting major obstacles were lumbar punctures (26%), bone marrow biopsies (22%), lymph node biopsies (13%) and rectal biopsies (13%). specific side effects such as hair loss (32%) and vomiting (23%) would be a withdrawal reason. Practical problems such as failure of parking at the clinic (20%) or getting transportation (17%) could also discourage participation in a study.
A small group of people living with HIV were interviewed and asked to them what can be "too much risk" to participate. Some of their answers were:
"Try one approach never tested in humans."
"Genetic manipulations that could result in cancer would probably be the most frightening and unbearable."
"If I were to become resistant to drugs that are saving my life on this."
"A risk that would take my health to an irreversibly worse situation than I am now."
"Risk of death greater than 1%".
Doctors and researchers who were interviewed also had views on what would constitute a risk of "very high". Most said the transplant unhealthy stem cells in noncancerous participants or that are stable and with suppressed viral load on antiretroviral therapy would be too risky. Another protein was mentioned anti-1 programmed cell death (apoptosis) which has shown significant toxicity in animal studies.
Similarly, regulators who were interviewed said that some studies have been too risky to continue. If there was insufficient data to assess the risk or the potential benefits insufficient when it comes to overcoming the risks, approval is not given. A poorly designed study would be unable to take us closer to a cure, although the exposure of participants to risk.
A specific study of the procedure that could expose participants to damage is a treatment with an analytical interruption. Interrupting antiretroviral treatment in order to assess the time to viral rebound or rebound predictors is also a factor of refusal. Of those surveyed, 26% reported that they were very willing to it and 42% very unwilling to stop your treatment.
During the interviews, motivations to be included by a desire to help find a cure( "Know that you're a part of something that can help many people in the future"), Past experiences with treatment interruptions( "They left me without drugs for three years, and in three years my CD4 count never dropped below 550.")
And financial benefits( "Would be less expensive not have to take medicine for 6 months") Translator's note. Not all countries offer treatment and bear the financial costs of a treatment against AIDS is something that challenges the most solid of the family assets, coming, as many came, bankrupt, then there was no interruption to treatment and rest ... one can imagine for themselves ...
But other participants saw an interruption of treatment as something that would be "too risky." They were concerned because they could feel an increase in viral load, could transmit HIV could develop resistance or could have opportunistic infections.
Taking into account some of the misconceptions and concerns that emerged from the study, US researchers said a more comprehensive education and engagement of stakeholders are necessary. They make a number of recommendations including:
- People living with HIV should be engaged at an early stage in curing HIV research, using guidelines for good participatory practice (GPP).
- Transparency about the research objectives, expected results and processes is crucial to combat rumors and setting realistic expectations of the initial phase of the investigation.
- Researchers have an ethical duty to inform potential risks to study participants and to explain the lack of expected clinical benefits.
- Participants of HIV cure research should know that interventions are experiments that evaluate the basic safety and are designed to generate knowledge for the benefit of society.
- The perception of what constitutes a "too much risk" should be taken into account when drafting and approval of studies; there should be safeguards to protect participants to take unacceptable risks.
- Risks assumed by the participants should be minimized and be reasonable in relation to the importance of scientific research and knowledge that can be generated.
- Fatigue treatment should not be used as a way to attract volunteers for studies involving an analytical treatment interruption.
- Published: 31 2016 August
- Translated by Claudio Souza the rise inRealism needed about the benefits and risks of taking part in HIV cure studies
- reviewed by Mara Macedo
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Sylla L et al.Perceived benefits of HIV research healing related to participation in the United States.XXI International AIDS Conference, Durban, abstract WEPED308, 2016.
Taylor J et al.The perceived risks of participants in research related to HIV cure in the United States.XXI International AIDS Conference, Durban, abstract WEPED310, 2016.
K Dubé et al.What is "too much risk" in curing HIV clinical research in the United States?XXI International AIDS Conference, Durban, abstract THPEB076, 2016.
D Evans et al.Treatment interruptions in HIV cure research in the United States: perceptions, motivations and ethical considerations of potential HIV positive patients volunteers.XXI International AIDS Conference, Durban, abstract THPDD0104, 2016.