HPTN 052 is the name of a

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...

conducted in nine countries which examined whether starting people living with

HIV The human immunodeficiency viruses (HIV) are two species of ''Lentivirus'' (a subgroup of retrovirus) that infect humans. Over time, they cause acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune ...

antiretroviral therapy The management of HIV/AIDS normally includes the use of multiple Antiviral drug, antiretroviral drugs as a strategy to control HIV/AIDS, HIV infection. There are several classes of antiretroviral agents that act on different stages of the HIV life- ...

(ART) can reduce the chance that they will pass HIV on to their sexual partners who do not have HIV. The trial showed remarkable success in preventing HIV transmission and were so compelling that the study's Data and Safety Monitoring Board (DSMB) asked the research team to share the results with all study participants and offer ART to the control group (people who had been

randomized In common usage, randomness is the apparent or actual lack of pattern or predictability in events. A random sequence of events, symbols or steps often has no order and does not follow an intelligible pattern or combination. Individual rand ...

to not start ART) before the study ended. As a result of the study there was increased consensus that

treatment as prevention Treatment as prevention (TasP) is a concept in public health that promotes treatment as a way to prevent and reduce the likelihood of HIV illness, death and transmission from an infected individual to others. Expanding access to earlier HIV diagn ...

should be included as a public health strategy in lowering HIV infection. The trial was organized by the HIV Prevention Trials Network (HPTN) and its chief architect was Myron S. Cohen.

Results

As reported by a 2011 publication in the ''

New England Journal of Medicine ''The New England Journal of Medicine'' (''NEJM'') is a weekly medical journal published by the Massachusetts Medical Society. It is among the most prestigious peer-reviewed medical journals as well as the oldest continuously published one. Hist ...

'', in the trial there were 1763 couples, where only one partner was infected with HIV. After following them for a

median In statistics and probability theory, the median is the value separating the higher half from the lower half of a data sample, a population, or a probability distribution. For a data set, it may be thought of as "the middle" value. The basic fe ...

of 1.7 years, there were 4 HIV infections in the group on ART and 35 in the group not on ART. However, when comparing the HIV viruses in the 4 infections in the ART group, 3 of them were different than that of the partner who had originally had HIV. It is likely that these were contracted from another sexual partner, who was not involved in the trial. Therefore, only 1 transmission was recorded in the ART group with 886 couples followed for almost 2 years. That was estimated to be a 96% reduction from the control group, who had only started on ART if they had become sick or their

CD4 In molecular biology, CD4 (cluster of differentiation 4) is a glycoprotein that serves as a co-receptor for the T-cell receptor (TCR). CD4 is found on the surface of immune cells such as T helper cells, monocytes, macrophages, and dendritic ...

cell counts had dropped below 250. It is also notable that both groups had received extensive counseling, condoms, and STI treatment. After the finding of such a drastic reduction in transmission the control arm was stopped prematurely in 2011 and all participants were offered ART. Couples were followed for four more years and by 2015, 1,171 couples were still being followed when the study was completed. As reported in a follow-up publication in the

, only 8 cases of HIV transmission were recorded from patients on ART and 4 of them happened in the first three months after treatment was started and before the virus was able to be suppressed. The other 4 were in patients who had detectable levels of virus in their blood despite being on ART, likely due to resistance and virologic failure. Overall there was a sustained 93% reduction in HIV transmission.

Ethics

This study was groundbreaking for providing compelling evidence that treating persons with HIV actually reduces HIV infection rates in communities. Now that this information is available, it has created debates about ethical obligations which communities might have when making decisions about providing HIV treatment.

Reception

In December 2011, ''

Science Science is a systematic endeavor that builds and organizes knowledge in the form of testable explanations and predictions about the universe. Science may be as old as the human species, and some of the earliest archeological evidence for ...

'' named the study as "

Breakthrough of the Year The Breakthrough of the Year is an annual award for the most significant development in scientific research made by the AAAS journal ''Science,'' an academic journal covering all branches of science. Originating in 1989 as the ''Molecule of the Ye ...

References

External links

HPTN's page for HPTN 052Wiki Journal Club's more extensive analysis of the publication
{{Breakthrough of the Year Clinical trials related to HIV