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Found 4 Actively Recruiting clinical trials

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Actively Recruiting

Healthy Volunteer

Researchers are looking for new medicines to prevent HIV-1 (Human Immunodeficiency Virus Type 1) infection. The goals of this study are to learn: * If taking MK-8527 once a month works to prevent HIV-1 infection as well as or better than a standard (usual) pre-exposure prophylaxis (PrEP) taken once a day * About the safety of MK-8527 and if people tolerate it

Age: 16Years +All GendersPhase 3
81 locations
D

Actively Recruiting

Researchers are evaluating doravirine combined with tenofovir and lamivudine as an alternative to dolutegravir combined with tenofovir and lamivudine or emtricitabine in adults living with HIV-1 who have never received treatment before. This Phase III, open-label, randomized, non-inferiority trial is conducted in multiple countries including Brazil, Cameroon, Côte d'Ivoire, France, Mozambique, and Thailand. The study aims to compare the effectiveness of these regimens by measuring the control of HIV viral load at 48 weeks. Participants will be randomly assigned to receive either doravirine plus tenofovir and lamivudine or dolutegravir plus tenofovir and lamivudine or emtricitabine, all given orally. The study will follow 610 participants for a total of 96 weeks after starting antiretroviral therapy. Primary evaluation focuses on the proportion of participants who achieve a viral load below 50 copies/mL at week 48. Secondary assessments will be performed at weeks 48 and 96. During the trial, participants will undergo regular monitoring including laboratory tests to measure viral load and kidney and liver function. The study will also assess safety and adherence to treatment. Participants must provide informed consent and will be closely followed throughout the study duration to ensure accurate outcome measurements and safety monitoring.

Age: 18Years +All GendersPhase 3
19 locations
I

Actively Recruiting

Healthy Volunteer

Researchers are evaluating how well long-acting lenacapavir works to prevent HIV infection in people at higher risk in Brazil. This study also looks at the safety of lenacapavir, how many participants continue using their chosen prevention method over time, and whether people prefer this option compared to daily oral pre-exposure prophylaxis (PrEP). The study compares two prevention options: long-acting lenacapavir injections given every six months and daily oral PrEP pills containing tenofovir disoproxil fumarate and emtricitabine. Participants choose their preferred prevention method after counseling, and the study follows them for up to two years. About 1200 participants choosing lenacapavir will receive an oral loading dose over the first eight days, followed by subcutaneous injections every six months for up to two years, totaling up to four injections. Around 300 participants choosing oral PrEP will take a daily pill continuously for up to 24 months. Both groups will have regular clinic visits for HIV testing, safety assessments, STI screening and treatment, prevention counseling, and monitoring of medication adherence and side effects. During the study, participants will visit clinics regularly for HIV testing, health checkups, and prevention counseling. Researchers will monitor how well participants stay on their chosen prevention method and record any adverse events or injection site reactions. The main outcomes measured include how many remain on lenacapavir at 24 months and the time until stopping lenacapavir. The study aims to help health services in Brazil improve HIV prevention options and support for people wanting to prevent HIV infection.

Age: 16Years - 30YearsAll GendersPhase Not Applicable
8 locations
I

Actively Recruiting

Healthy Volunteer

Researchers are evaluating ways to improve access to HIV prevention using pre-exposure prophylaxis (PrEP) among underserved populations in Rio de Janeiro, including gay and bisexual men, transgender women, sex workers, and other vulnerable groups. The study focuses on whether delivering PrEP in community-based settings can overcome barriers faced by socially and economically disadvantaged people at higher risk of HIV infection. The study aims to assess the feasibility and acceptability of these new delivery methods and to support better engagement with HIV prevention. The study involves offering daily oral PrEP with tenofovir disoproxil fumarate/emtricitabine to HIV-negative participants through community-based models, including non-governmental organizations and mobile health units. Trained healthcare staff provide on-site HIV testing, counseling, and same-day PrEP initiation. Participants also have access to telehealth consultations and mobile health tools to support adherence and retention in care. Those who test positive for HIV will be referred promptly for treatment within the public health system. Participants will be involved in focus groups and structured questionnaires during the study to identify barriers and facilitators of PrEP use and to evaluate uptake, adherence, and HIV incidence. Clinical assessments and follow-up focus groups will provide insights into participant experiences with community-based PrEP delivery. The study will last up to 12 months, measuring the feasibility and acceptability of these approaches and informing strategies to improve equitable access to HIV prevention in socially and structurally unequal settings.

Age: 15Years +All GendersPhase Not Applicable
2 locations