Table 1.

Points to consider in HIV cure research

Principles	Applied to HIV cure research	Challenges
Collaborative  partnership	Finding a cure for HIV will require the collaboration  of international scientists from the private and  public sectors, as well as engagement of  HIV-affected communities and other stakeholders	Public–private sector collaboration is needed
		Scientists from different specialties and geographic areas will need to work together
		The voices and input of those infected with and affected by HIV are critical
Social value	Research directed toward an HIV cure should be  organized in ways that foster scientific progress  and move the science forward in useful ways.  Research relevant toward finding a functional or  sterilizing cure for HIV can build on the IAS road  map for HIV cure research	Preclinical and animal studies are necessary to provide a foundation for clinical trials
		All findings from HIV cure research, including negative findings, are important to  disseminate
Scientific validity	Each HIV cure study should be designed to provide  a rigorous answer to the valuable scientific question  related to curing HIV	Stepwise and deliberate design is necessary to ensure safety and dosing and  demonstrate proof of concept before wide-scale clinical trials are initiated
Fair selection of  participants	The selection of participants and study sites must be  equitable, also consistent with the imperative to  protect participants and carry out a scientifically  rigorous study, and guided by considerations of  the equitable distribution of the benefits and burdens  of HIV cure research	Early phase studies should enroll male and female adults who can provide their  own consent and who are willing to assume risk for the benefit of others. HIV  cure studies will include HIV-infected persons who are stable on long-term  antiretrovirals, those who are sick with HIV-associated illnesses such as  lymphoma, and healthy volunteers. Studies with children and adolescents  should follow with promising interventions found well tolerated in adults. Sites  should be selected that have the scientific, logistical, and ethical capacity to  conduct the specific trial
Favorable risk–benefit  balance	Research risks must be minimized and acceptable in  relation to the prospective benefits  to study participants or of the knowledge to be generated	In early trials, participants will assume risks without the prospect of direct benefit.  Risks are uncertain and could be significant. Risks include those associated  with interventions being studied, the risk of viral rebound after stopping long  term antiretroviral therapy, the risks of research procedures that might be  invasive, and the risk of possible long-term adverse events
Independent review	Each study protocol should undergo coordinated  scientific and ethical review, approval from appropriate  ethics committees, institutional review boards, and  regulatory agencies	Multiple levels of review and oversight will be essential to assure scientifically  and ethically appropriate research acceptable to relevant communities
Informed consent	Participants should give informed and voluntary consent	Special effort should be made to assure that participants in early studies  understand the potential risks and lack of direct benefit. Understanding should be  carefully assessed especially because of the possible distorting influence  of a desire for a cure
Respect for enrolled  participants and  communities	Individuals who accept the risks associated with finding  a cure for HIV should be carefully monitored, have their  rights protected, receive compensation for any research  related injuries. Plans should be in place regarding  how interventions found safe and effective will be  available and affordable to research participants and  communities	Monitoring systems should be in place to allow rapid intervention  for individuals whose virus rebounds or who suffer adverse events.  Medical care should be provided for those who suffer any research  related injuries. Discussions and planning for making successful  interventions available should start early in the clinical trial process