Iquitos

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

Researchers are evaluating molnupiravir, a study medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 more effectively than a placebo. This Phase 3 randomized, placebo-controlled, double-blind study focuses on non-hospitalized adults at high risk of severe disease progression due to COVID-19. The study addresses the need for alternative treatments for people who cannot take certain COVID-19 medications due to availability or potential drug interactions. Participants will receive either molnupiravir or a placebo, both given orally as two 400 mg film-coated tablets every 12 hours for 5 days, totaling 10 doses. Some participants may also receive remdesivir as part of standard care if clinically appropriate and available. The study compares the effects of molnupiravir with placebo in preventing severe illness outcomes. Throughout the study, participants will be monitored for outcomes such as hospitalization, death, or medically attended visits related to COVID-19 up to 29 days. Safety is assessed by tracking adverse events for up to about 5 months and discontinuation of study treatment due to adverse events for about 5 days. The study involves laboratory tests, symptom assessments, and safety evaluations to understand molnupiravir's impact on disease progression and participant health.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and neutralization of three broadly neutralizing monoclonal antibodies—VRC07-523LS, PGT121.414.LS, and PGDM1400LS—administered intravenously in adults without HIV. This is a randomized, double-blind, controlled phase 2 clinical trial involving approximately 200 adult participants aged 18 to 65 years. The study aims to understand how these antibody combinations behave in the body and their safety profile over an 18-month participation period. Participants will receive intravenous infusions of the antibodies at different dosages: VRC07-523LS at 400 mg or 3200 mg, PGT121.414.LS at 400 mg or 1600 mg, and PGDM1400LS at 400 mg or 1600 mg. The study includes controlled administration of these biological treatments to assess their effects at varying dose levels. During the study, participants will undergo multiple assessments including monitoring for local and systemic adverse events at specific days (1, 4, 7, 169, and 173), and monitoring for unsolicited and serious adverse events throughout 48 weeks. Laboratory tests will evaluate changes in liver enzymes (ALT, AST, alkaline phosphatase), kidney function (creatinine), and complete blood count at baseline and several points up to day 337. Researchers will also track any early discontinuations and overall tolerability throughout the study duration.

Researchers are evaluating the effectiveness of focal mass drug administration (fMDA) to reduce the incidence of Plasmodium vivax malaria in the Loreto Department of Peru. This open-label, cluster-randomized controlled trial compares standard malaria interventions—including symptomatic and asymptomatic screening, insecticide-treated bednet provision, and environmental monitoring—with fMDA targeted at high-risk villagers living near recent malaria cases. The study takes place in a low transmission region and aims to assess safety, cost-effectiveness, and the impact of fMDA on malaria transmission over three years. The trial involves two study arms: control and fMDA. Villages are randomized to receive either standard interventions or fMDA, which is administered in two rounds per cycle, with three cycles spaced apart. The first round includes three days of chloroquine combined with tafenoquine for participants aged 16 and older, or chloroquine plus primaquine for younger children or those with certain enzyme activity levels. The second round consists of single-dose chloroquine combined with either tafenoquine or primaquine depending on eligibility. High-risk individuals are those living within 200 meters of a confirmed malaria case in the prior two years. If pediatric tafenoquine becomes approved during the trial, the protocol may be updated. Participants will be monitored through baseline, interim, and endline surveys during the three-year intervention period. Blood samples will be collected, and anyone with recent fever and a positive blood smear will receive treatment per national guidelines. The study will track cumulative incidence of malaria infections, safety through adverse event monitoring, and cost-effectiveness. The trial is designed to be pragmatic and integrated into the existing health system to maximize public health relevance.

Researchers are investigating how three types of menstrual products—menstrual pads, tampons, and menstrual cups—affect the bacterial makeup of the vaginal microbiome. The study takes place in three countries: Peru, Cameroon, and Switzerland. It uses a randomized crossover design where participants use each product in a specific sequence over a total duration of six months, with each menstrual product used for two menstrual cycles before switching to the next. Participants will be randomly assigned to one of six different sequences to use the menstrual products. Each participant will adopt each product for two menstrual cycles, providing vaginal microbiome samples through self-collected swabs at three points during each menstrual cycle. Self-sampling kits with swabs and menstrual products will be supplied before each menstrual cycle. Throughout the study, participants will collect vaginal samples monthly after menstruation ends, for approximately six months. These samples will be analyzed to measure changes in the bacterial populations, focusing on the balance between Dialister and Lactobacillus crispatus. The study does not include a separate control group due to its crossover design. Researchers will monitor the vaginal microbiome composition, and participants will be closely followed during the entire study period.