By Myron S. Cohen
June 2011 — On April 28, 2011, an NIH Data Safety and Monitoring Board—a group designed to protect the interests of study subjects in clinical trials—made an unusual request. They asked that preliminary data from a large international study, HIV Prevention Trials Network (HPTN) 052, be made public before the study was completed and before the results could be presented to the scientific community.
The request was made because the board felt that the results were of critical public health importance and should be made available as soon as possible. I serve as the leader of HPTN 052 .
Nearly twenty years ago, scientists at Burroughs Wellcome developed the first drug to stop the replication of HIV-1. This drug, known as AZT, proved to be life-saving. It was the first big “game-changer” in the battle against HIV/AIDS.
Here at UNC, we decided to work on what would seem an important question: would AZT—and ultimately many other antiretroviral drugs— stop the growth of HIV-1 in the genital tract. If this proved to be the case, we reasoned, treatment of HIV-1 would also serve as prevention. A large team from UNC, including Ron Swanstrom (biochemistry) , Joe Eron (medicine), Susan Fiscus (laboratory medicine) and Angela Kashuba (pharmacology) and me, as well as dozens of students and postdoctoral trainees, committed themselves to this work. By 2000, after nearly a decade of work, we were convinced that certain classes of drugs could prevent the sexual transmission of HIV-1.
That same year I led a protocol team who started the HPTN 052 project. In 2003 we were able to get six U.S.-based pharmaceutical companies to donate the drugs necessary for a clinical trial. In 2005 we received permission from the NIH to pilot the trial in 100 “discordant” couples (couples in which one partner has HIV and the other does not) and examine the effect of early antiviral treatment on personal health and prevention of HIV-1 transmission.
Starting in 2007, we enrolled nearly 2000 couples at 13 sites in nine countries around the world. We completed recruitment of the couples in May 2010 and planned the study to run till at least 2015. But on May 12, 2011, during an international press call, we announced the remarkable results, as requested by the monitoring board: early treatment with antiviral therapy reduced sexual transmission of HIV-1 by at least 96.3%.
These results became really big news very quickly. The media and the HIV/AIDS research and advocacy communities have been recognizing the 30th anniversary of AIDS, and this was a very encouraging bit of news coinciding with that milestone.
This summer the HPTN 052 team will formally present our results at the International AIDS Society meeting in Rome and hope to publish them soon thereafter.
We are not running on the “fast track.” It took us a decade to prove we had the right idea, a decade to show that the idea worked, and it will probably take the better part of another decade to translate the observation to a clinical reality. For the investigators at UNC and our collaborators around the world, this represents quite literally a lifetime of work. But we’re not finished yet. It’s time to get back in the race and keep on moving forward.
Each month, Dr. Cohen writes a “Global Health Update” column for the UNC Global Newsletter. We reprint the item here.