Microbicide Trials Network

Dear MTN Friends and Colleagues,
 
We would like to congratulate Dr. Connie Celum and the Partners in Prevention team on the release of their HSV/HIV Transmission Study results on May 8. People co-infected with HSV-2 and HIV who were randomized to acyclovir did not have a reduced risk of transmitting HIV to their partners compared to placebo-treated study participants. The study delivered on its promise to provide us with the answers to the question of whether treatment of HSV-2 can reduce HIV spread, a question of clinical and public health significance. We thank Connie Celum and the entire Partners in Prevention team for contributing greatly to our understanding of the relationship between HIV and HSV-2. A study of this magnitude could not have been conducted without the collective efforts of all involved. Partners in Prevention is based at the University of Washington but includes among its many collaborators a roster of outstanding site investigators, and has received support from the Bill and Melinda Gates Foundation.
 
The Partner's Study is the first clinical trial to determine whether suppressing HSV-2 infection could reduce HIV transmission and HIV disease progression. Specifically, the study was designed to determine whether twice daily use of acylcovir by individuals co-infected with both HSV-2 and HIV could reduce the risk of transmitting HIV to their uninfected partners. The HIV-infected partners in the study had CD4 counts of > 250 cells/mm3 and not yet begun treatment with ARVs at the time of enrollment. After 12-24 months of follow-up, acyclovir treatment reduced the frequency of genital ulcers by 73% and HIV viral load by 40% (0.25 log10 copies/milliliter) compared to placebo, although these effects were not sufficient to reduce the risk of HIV transmission. The infections in the acylcovir and placebo arms were 41 and 43, respectively, a difference that was not statistically different.
 
Although discordant couples represent the largest risk group for HIV infection in Africa, many had wrongly assumed that as a study population the challenges for recruitment and retention would hinder the trial's success. Remarkably, the team tested an estimated 50,000 couples in order to enroll 3,408 discordant couples across 14 sites in seven countries in east and southern Africa. Moreover, the team achieved high retention rates for both the HIV-infected participants and the HIV-negative partners in the study. The same model is already seeing success in the Partners PrEP Study, which in less than a year has enrolled more than 1,000 discordant couples.
This is a remarkable achievement.
 
Achievements such as these are especially inspiring as we get ready to launch VOICE, a similarly ambitious study. The success of our colleagues is also instructive because it demonstrates that, yes, even in severely resource-limited settings, scientifically rigorous, high quality clinical trials can be conducted.
 
Please join me in congratulating the Partners in Prevention team and in wishing them continued success in their ongoing efforts. We hope that Connie and other members of our team will share these data with us during the upcoming MTN Regional Meeting to be held in Cape Town, South Africa from October 19-22.
 
Sincerely,
 
 
 
Sharon Hillier