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May 4, 2017

IPM initiates Phase I trial of vaginal ring to prevent HIV and unintended pregnancy

Non-profit organisation International Partnership for Microbicides (IPM) has initiated the Phase I MTN-030/IPM 041 clinical trial of its three-month vaginal ring developed to prevent HIV and unintended pregnancy in women.

Non-profit organisation International Partnership for Microbicides (IPM) has initiated the Phase I MTN-030/IPM 041 clinical trial of its three-month vaginal ring developed to prevent HIV and unintended pregnancy in women.

The ring uses technology similar to the dapivirine-only ring and is designed to slowly and simultaneously release the antiretroviral drug dapivirine, as well as the contraceptive hormone levonorgestrel.

Dapivirine is a non-nucleoside inhibitor of reverse transcriptase enzyme with the ability to block the self-replication of HIV, while levonorgestrel is a type of progestin.

Set to be conducted at two clinical sites in the US, the randomised, double-blind trial will be led by IPM's clinical trial partner Microbicide Trials Network (MTN) and funded by the US National Institutes of Health (NIH).

The trial will evaluate the 200mg dapivirine and 320mg levonorgestrel-carrying ring for 14 days in 24 healthy, non-pregnant women aged between 18 to 45.

IPM founder and chief executive officer Dr Zeda Rosenberg said: “Women’s sexual and reproductive health needs do not exist in isolation, and neither should their prevention options.

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"The only way to end the HIV epidemic is to offer women product options that meet their various needs, and IPM remains committed to making this a reality."

"A long-acting product that gives women two prevention methods in one may be quite appealing.

“The only way to end the HIV epidemic is to offer women product options that meet their various needs, and IPM remains committed to making this a reality.”

The vaginal ring, containing 200mg dapivirine alone, will be used as a placebo for comparison.

The study's primary objective is to evaluate the safety and pharmacokinetics of the ring by measuring levels of the two drugs in blood and vaginal fluid.

With results expected by mid-2018, the trial will also examine product acceptability among the subjects.

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