After participants are assigned at random to either the cabotegravir group or the Truvada group, they will participate in the study for the duration of four and a half years. For the first five weeks following enrollment, the participants will be administered two tablets—either of cabotegravir, Truvada, or placebo—to be taken daily. On the sixth week, “participants in the cabotegravir group will receive injections of cabotegravir and placebo tablets to be taken orally daily, while participants in the Truvada group will receive placebo injections with Truvada tablets to be taken orally daily.” According to the press release, participants will receive the first two injections 4 weeks apart and then, after that, participants will receive their injections once every 8 weeks for the rest of the study. When participants have received all of the injections, they will have the opportunity to receive 48 weeks of pre-exposure prohylaxis along with Truvada (to be taken daily).
Furthermore, all study participants will be provided with counseling on both prevention and adherence to the oral pill and will be supplied with condoms and lubricant. If participants acquire a sexually transmitted disease (STD) during the study, they will be referred to local healthcare providers for appropriate treatment and will stop receiving the study products.
HIV remains a public health concern around the world and researchers hope that this drug might be a more convenient way to prevent infection and increase adherence. There are a number of reasons why adhering
to medical treatment for HIV can be difficult: individuals may have trouble swallowing pills; a busy schedule may prevent the individual from taking the medication on time; or they might not want to call attention to the fact that they have the virus. With an 8-week, injectable dosage, researchers feel that it will be easier for individuals to adhere to the treatment in a much more discreet manner.
HPTN 083 Protocol Chair Raphael J. Landovitz, MD, MSc, said, “The annual number of new HIV infections among young men who have sex with men and transgender women who have sex with men, has been on the rise despite nearly flat HIV incidence among adults worldwide. It is essential to develop multiple effective HIV prevention modalities so the most vulnerable populations have a choice of preventive options. We hope injectable cabotegravir will become one such modality.”
The researchers noted that this is not the only study that will test injectable cabotegravir; it will also be tested for effective HIV prevention in women in a study called HPTN 084. The study will begin next year and focus on younger women in sub-Saharan Africa, a place that has been heavily hit with the virus.
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