SA women part of ARV injection trial

Organisation: Position: Deadline Date: Location:

South African women are going to part be part of a trial to test an antiretroviral injection‚ to see if it can prevent them from contracting HIV. The Times reports that this was announced by trial sponsor US National Institutes of Health (NIH) ahead of World Aids Day.

The trial on 3,200 women in southern and eastern Africa is meant to try and find a way for women to prevent contracting HIV without needing to take a daily preventative pill or having to rely on their partner using a condom.

The report says the only medication currently licenced for HIV prevention is Truvada‚ a pill that must be taken even day and can reduce the risk of becoming infected with HIV by 90% and some women struggle to take a pill daily.

Truvada is going to be used in the study – the report says it will be given to half of the women and will be compared with the injection given to the other half to see which works better to prevent HIV. The injection contains an ARV drug called Cabotegravir. The first two injections will be four weeks apart‚ then once every eight weeks for an average of 2.6 years.

Anthony Fauci‚ director of the US National Institute of Allergy and Infectious Diseases (Niaid)‚ part of NIH‚ said: “Taking a daily pill can be challenging for some people. For some women‚ a long-acting injectable form of protection may be an easier‚ more desirable and discreet alternative.”

The leader of the study is a South African: Sinead Delany-Moretlwe‚ associate professor and director of research at the Wits Reproductive Health and HIV Institute at the University of the Witwatersrand. She is quoted in the report as saying: “Current HIV prevention tools can be especially difficult for women to control or negotiate with a partner. An effective‚ long-acting injectable drug would allow a woman to discreetly protect herself from HIV.”

She said scientists are trying to find different HIV prevention options for females‚ so they have choices in the same way women have a choice of different contraceptive methods. The trial will enrol approximately 3,200 sexually active women aged 18 to 45 years at 20 sites in seven countries in southern and eastern Africa‚ including South Africa.

The women will be divided into two groups. All women will get a daily pill and injections every two months or so. One group will be getting the Truvada pill and a placebo injection. The other group will get the real Cabotegravir injection and a fake daily pill. All participants get both a pill and an injection‚ so no one knows who is getting the real injection or the real pill. After three years‚ scientists will check which group has a lower number of HIV infections to see which was the best prevention method.

The report says the NIH is sponsoring the trial in a partnership with pharmaceutical company ViiV Healthcare and the Bill & Melinda Gates Foundation. Study participants are to receive HIV prevention counselling‚ condoms and lubricant‚ as well as counselling to encourage and support adherence to the daily pill.

Trial participants will be tested for HIV at least every eight weeks‚ and those who become HIV-infected during the trial will stop receiving the study products and given HIV treatment.

The Times report

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