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A new study will test three
maraviroc-based regimens to evaluate the HIV drug’s use to prevent infection in
healthy people at risk of the virus. The National Institutes of Health (NIH),
whose announcement followed the Food and Drug Administration’s approval Monday
of the HIV treatment Truvada for pre-exposure prophylaxis (PrEP), is funding
most of the study.
Researchers will test maraviroc (Selzentry)
in HIV-negative gay and bisexual men, with an aim of 400 participants enrolled
in the United States and Puerto Rico. Volunteers in the placebo-controlled
trial will be assigned to one of four regimens - three with maraviroc, and one
with Truvada - for 48 weeks.
Selzentry gained US approval in 2007
and works by inhibiting a pathway HIV uses to infect cells in most newly
diagnosed patients. NIH said study leaders want to test other drugs for PrEP
due to concerns about possibly serious side effects from Truvada and other
previously tested drugs. They also worry about the emergence of drug-resistant
viral strains; this has not been widely seen with Selzentry to date.
Drugmakers Gilead Sciences Inc. and
ViiV Healthcare will donate Truvada and Selzentry, respectively, to the study.
Roy M. Gulick, infectious-diseases division chief at Weill Cornell College in
New York, will lead the trial.
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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