In 2008, researchers reported that Timothy Brown , a man with HIV infection and leukemia, received a stem-cell transplant that removed HIV from his body as far as can be detected. In 2013, an infant born with HIV infection received anti-retroviral treatment shortly after birth, but was then lost to the health care system for the next six months. When tested for HIV upon return, the child had no detectable viral load despite cessation of treatment. These remarkable clinical developments have (...) helped reinvigorate the field of ‘HIV cure’ research. (shrink)

Ethical challenges surrounding the implementation of male circumcision as an HIV prevention strategyResearchers have been exploring the possibility of a correlation between male circumcision and lowered risk of HIV infection almost since the beginning of the HIV/AIDS epidemic.1 Results from a randomised controlled trial in South Africa in 2005 indicate that male circumcision protects men against the acquisition of HIV through heterosexual intercourse,2 confirming the findings from 20 years of observational studies.3 Circumcised men in the South African trial were 60% (...) less likely to acquire HIV than their uncircumcised counterparts. A mathematical modelling study, based on the South African trial, estimates that the practice of male circumcision could avert two million new HIV infections and 300 000 HIV-related deaths over the next 10 years in sub-Saharan Africa.4 More recently, two randomised controlled trials in Kisumu, Kenya and Rakai, Uganda showed, respectively, 53% and 48% reductions in HIV acquisition among circumcised men than uncircumcised men in the trial.5 These results strongly suggest that male circumcision could play an important role in the struggle against the continued rise in new HIV infections. However, as observers noted at the 2006 XVI International AIDS Conference in Toronto, Canada, excitement about the potential epidemiological impact has overshadowed the debate over the difficult translation of research on male circumcision, into policy and practice.6 Similar calls for caution have been raised before and elsewhere.7,8The topic of male circumcision carries an enormous amount of ethical baggage. Male infants, worldwide, are circumcised for various medical, social and/or religious reasons. Circumcision is a cultural act and a surgical procedure; medical reasons are not the only reasons to circumcise that people have found and continue to find as compelling. Benatar and Benatar9 have argued that—when …. (shrink)

Background HIV prevention research has been fraught with ethical concerns since its inception. These concerns were highlighted during HIV vaccine research and have been elaborated in microbicide research. A host of unique ethical concerns pervade the microbicide research process from trial design to post-trial microbicide availability. Given the urgency of research and development in the face of the devastating HIV pandemic, these ethical concerns represent an enormous challenge for investigators, sponsors and Research Ethics Committees (RECs) both locally and internationally. Discussion (...) Ethical concerns relating to safety in microbicide research are a major international concern. However, in the urgency to develop a medically efficacious microbicide, some of these concerns may not have been anticipated. In the risk-benefit assessment of research protocols, both medical and psycho-social risk must be considered. In this paper four main areas that have a potential for medical and/or psycho-social harm are examined. Male partner involvement is controversial in the setting of covert use of microbicides. However, given the long-term exposure of men to experimental products, this may be methodologically, ethically and legally important. Covert use of microbicides may impact negatively on relationship dynamics leading to psychosocial harm to varying extents. The unexpectedly high rates of pregnancy during clinical trials raise important methodological and ethical concerns. Enrollment of adolescents without parental consent generates ethical and legal concerns that must be carefully considered by RECs and trial sites. Finally, paradoxical outcomes in recent trials internationally have advanced the debate on the nature of informed consent and responsibility of researchers to participants who become HIV positive during or after trials. Summary Phase 3 microbicide trials are an undisputed research and ethical priority in developing countries. However, such trials must be conducted with attention to both methodological and ethical detail. It is imperative that guidelines are formulated to ensure that high ethical standards are maintained despite the scientific urgency of microbicide development. Given the controversy raised by emergent ethical issues during the course of microbicide development, it is important that international consensus is reached amongst the various ethics and regulatory agencies in developing and developed countries alike. (shrink)