Nova Iguacu

Researchers are evaluating new medicines to prevent HIV-1 Human Immunodeficiency Virus Type 1 infection. This Phase 3 clinical study aims to determine if taking the drug MK-8527 once a month can prevent HIV-1 infection as well as or better than the standard daily pre-exposure prophylaxis PrEP. The study also assesses the safety and tolerance of MK-8527 in participants. Participants are randomly assigned to one of two groups. One group receives 11 mg of MK-8527 once monthly along with a daily placebo pill matching FTCTDF. The other group receives a daily dose of FTC245 mg TDF and a monthly placebo matching MK-8527. This treatment period lasts for approximately two years, followed by an additional 28-day period where all participants receive open-label FTCTDF daily. During the study, participants will undergo regular monitoring to check for HIV-1 infection and any adverse events. Researchers will track the number of participants who acquire HIV-1, experience side effects, or stop treatment due to side effects over the two-year period. Safety and adherence assessments will be conducted to evaluate the study treatments. The total participation time includes the two-year treatment phase plus the 28-day follow-up with open-label FTCTDF.

Researchers are evaluating doravirine as an alternative to dolutegravir in people newly diagnosed with HIV-1 infection who have not yet received treatment. This Phase III, open-label, randomized clinical trial aims to determine if doravirine combined with tenofovir and lamivudine is not less effective than dolutegravir combined with tenofovir and lamivudine or emtricitabine. The study will be conducted across multiple countries including Brazil, Cameroon, Cte dIvoire, France, Mozambique, and Thailand, enrolling 610 participants. Participants will be randomly assigned to one of two groups one receiving doravirine 100 mg plus tenofovir DF 300 mg and lamivudine 300 mg daily, and the other receiving dolutegravir 50 mg plus tenofovir DF 300 mg and either lamivudine or emtricitabine daily. The treatment period will last for 96 weeks after starting antiretroviral therapy ART, with primary assessment at week 48 to measure viral suppression. During the study, participants will undergo evaluations to monitor viral load, drug resistance, metabolic health, body weight changes, liver and kidney function, cardiovascular status, and mental health. Adherence to ART will be tracked, and blood samples will be taken to measure drug levels and immune cell counts. The research team will review virological efficacy and safety outcomes at weeks 48 and 96, supporting a comprehensive understanding of the treatments effects over nearly two years of participation.

Researchers are evaluating how well long-acting lenacapavir works to prevent HIV infection in people at higher risk in Brazil. The study aims to assess safety, continued use over time, and participant preference compared to daily oral pre-exposure prophylaxis PrEP. It focuses on how many participants get HIV while using lenacapavir, its safety in real-world health settings, and factors affecting ongoing prevention use. Participants can choose between two prevention options injections of long-acting lenacapavir under the skin every six months or daily oral PrEP pills containing tenofovir disoproxil fumarate and emtricitabine. Those choosing lenacapavir receive an oral loading dose followed by subcutaneous injections at enrollment and every six months, up to four injections during follow-up. Those choosing oral PrEP take daily pills with regular medication dispensing and follow-up visits. Both groups receive prevention counseling, regular HIV testing, and screening for sexually transmitted infections and viral hepatitis. Participants will visit clinics regularly for HIV testing, health checkups, and safety monitoring. They will answer questions about their health, medication use, and experiences, while researchers evaluate adherence, injection site reactions, and adverse events. The study will track persistence on lenacapavir over 24 months and time to discontinuation. This research will help health services understand how to offer and support long-acting HIV prevention in Brazil, with follow-up lasting up to two years.

This research aims to improve access to HIV prevention by increasing the use of pre-exposure prophylaxis PrEP among underserved groups in Rio de Janeiro, including gay and bisexual men, transgender women, and sex workers. It focuses on populations at higher risk who face obstacles to accessing and continuing PrEP, especially those living in socially and economically vulnerable communities. The study evaluates whether delivering PrEP through community-based settings can enhance uptake and continued use. Participants will receive HIV prevention services in non-traditional community settings such as non-governmental organizations and mobile health units. Daily oral PrEP with tenofovir disoproxil fumarateemtricitabine will be offered to those who test HIV-negative, alongside counseling and follow-up support. Telehealth consultations and mobile health mHealth tools will also be used to support adherence and retention. Those who test positive for HIV will be referred to appropriate treatment within the public health system. During the study, participants will undergo HIV testing, counseling, and clinical monitoring. Data will be collected through questionnaires and clinical assessments to evaluate PrEP uptake, adherence, retention, and HIV incidence over up to 12 months. Follow-up focus groups will provide insights into participants experiences with community-based PrEP delivery. The study will monitor the feasibility and acceptability of this approach and assess engagement with digital support tools.