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US National Institutes of Health
(NIH) researchers report that a reduced-glycerin formulation of tenofovir gel
was safe and acceptable to HIV-negative women and men who used the anti-HIV gel
rectally in a phase I clinical trial (MTN-007).
NIH is studying rectal microbicides
inserted rectally via an applicator as a means of preventing sexual
transmission of HIV. In addition to developing rectal-specific products, researchers
reformulated a vaginal product, tenofovir gel, for rectal use. The original
vaginal formulation caused gastrointestinal side effects when it was used
rectally.
The 2010 MTN-007 study divided 65
men and women into four groups for the one-week trial. One group used a reduced
glycerin formulation of tenofovir gel daily; one used a placebo gel daily; one
used the spermicide nonoxynol-9 daily; and one group used no gel. All study
participants underwent the same “study-related procedures and tests.” The three
groups using gels reported no significant differences in side effects. Eighty
percent had minor side effects, and only 18 percent reported moderate side
effects. Compliance with daily use was high (94 percent), and 87 percent stated
they would use the product again.
NIH plans a phase II multi-site
trial (MTN-017) of the reformulated tenofovir gel in the United States,
Thailand, South Africa, and Peru. The study will include 186 men who have sex
with men and transgender women, all of whom will cycle through three regimens:
daily use of tenofovir, use of tenofovir used before and after sex, and use of
a daily antiretroviral pill (Truvada). The study will compare the reformulated
tenofovir to Truvada and provide additional information about tenofovir gel
safety.
The full report, “A Phase 1
Randomized, Double Blind, Placebo Controlled Rectal Safety and Acceptability
Study of Tenofovir 1% Gel (MTN-007),” was published online in the journal PLoS
ONE (2013; doi:10.1371/journal.pone.0060147).
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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