These formulations along with the implant under study offer specific adherence advantages over daily oral PrEP. the Dapivirine ring 12 and possibly long-acting injectable ARVs, 13 are poised to be accessible soon. 7–10 Other novel long-acting PrEP agents and innovative delivery systems such as ARV containing intravaginal rings, viz. 11 Although daily oral PrEP has been shown to be consistently effective in men who have sex with men and transgender women globally, 5 6 results have been inconsistent in African women, most likely due to varying adherence. Since antiretrovirals (ARVs) were first shown by the CAPRISA 004 trial 4 in 2010 to prevent sexual transmission of HIV, the HIV prevention landscape has been transformed, principally through oral tenofovir (TFV)-containing pre-exposure prophylaxis (PrEP) 5–10 or through early ARV therapy initiation in HIV-positive individuals (treatment as prevention). 2 3 Despite their greater vulnerability, young women have limited access to non-user-dependent prevention options to reduce their risk for HIV acquisition. 1 Young women in this region are particularly vulnerable and acquire HIV infection 3–5 years earlier than their male peers. 1 Adolescent girls and young women in sub-Saharan Africa account for approximately 25% of all new HIV infections globally. Safety will be assessed by calculating the percentage change in creatinine clearance from baseline at weeks 4, 12, 24, 36, 72, 96 and 120, compared with the percentage change in the control group.ĭespite the global decline in HIV infections by 23% since 2010, the number of people who acquire HIV each year remains unacceptably high. The phase II component (Group 4) will assess extended safety, PK, tolerability and acceptability of the implant in 490 at risk women, randomised in a 1:1 ratio to the TAF implant and placebo tablet or to the placebo implant and an oral pre-exposure prophylaxis tablet. Data from this phase I trial will be used to determine the dosing, implant location and implant replacement interval for the phase II trial. The phase I trial (n=60) will assess the safety of one implant inserted in six participants (Group 1), followed by dose escalation components (Groups 2 and 3) assessing the safety, tolerability and PK of one to four TAF 110 mg implants releasing between 0.25 mg and 1 mg daily in 54 healthy women at low risk for HIV infection. You will find more interesting information on our blog page.Methods and analysis CAPRISA 018 is a phase I/II trial to evaluate the safety, acceptability, tolerability and pharmacokinetics (PKs) of a TAF free base subdermal silicone implant containing 110 mg of TAF with an anticipated 0.25 mg/day release rate. We use durable and long-lasting materials that are made by the leading manufacturers of the trade. The methods that we use when we repair fiberglass are truly flawless. We are licensed and insured and will not disappoint you. We have gained a long list of customers who have trusted us to provide them with a custom design of their boat. This is important to us, as we always try to improve our level of service. In addition, we are able to provide better customer service to our clients. Lund Marine is equipped with state of the art machinery and tools that allow us to provide a timely and efficient fiberglass repair. We work with clients who like to receive nothing but the most professional and detailed fiberglass services around. There is no other company in Dawsonville, GA or the surrounding regions that knows the business better than us, and our specialists can provide you with everything you need in order to obtain the boat of your dreams. If you are looking for a qualified fiberglass specialist, Lund Marine is the right company to call. Over the years, we have worked with many customers in the area providing them with exceptional custom boat designs. A hardtop for your Jeep, hardtop for your boat, even a fairing for a turbine for your airplane. We can fabricate & design any/all fiberglass to match any of your needs. Our team of experts have been in the trade for a long time, and they possess the skills and knowledge needed to customize your boat specifically to your visions. Lund Marine has 30 plus years of experience in the trade and has always provided an outstanding fiberglass repair service. Are you looking for the most experienced company to provide you with fiberglass repair in Dawsonville, GA or any of the surrounding areas? If so, then you should contact our specialists.
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