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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
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.
Actively Recruiting
Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the effectiveness of focal mass drug administration fMDA in reducing the incidence of Plasmodium vivax malaria in the Loreto Department of Peru. This open-label cluster-randomized controlled trial compares standard malaria control interventions with additional targeted drug administration in high-risk village clusters. The study aims to assess the impact of fMDA on malaria transmission, safety, and cost-effectiveness over a three-year period in a low transmission setting. Participants live in villages randomized to either standard malaria control measures or fMDA. Standard interventions include insecticide-treated bednets, management of mosquito breeding sites, symptomatic case detection, and treatment. The fMDA group receives two rounds of targeted antimalarial drugs per cycle, repeated for three cycles. Drugs used include chloroquine, tafenoquine, and primaquine, with dosing based on age and G6PD status. High-risk individuals are those living within 200 meters of confirmed malaria cases in the past two years. Testing and counseling for G6PD deficiency are done before drug administration. Participants are monitored through baseline and endline surveys collecting dried blood spots and fever screening with treatment per national guidelines. Safety is evaluated by tracking severe adverse events and malaria cases. Cost-effectiveness and acceptability of the intervention are also measured. The primary outcome is the cumulative incidence of P. vivax infection over 36 months. The trial is conducted pragmatically through the existing health system with follow-up extending over four years.
Actively Recruiting
Healthy Volunteer
Researchers are studying how three different menstrual products menstrual pads, tampons, and menstrual cups affect the bacterial makeup of the vaginal microbiome. This study takes place across three countries Peru, Cameroon, and Switzerland. The goal is to understand how these products influence vaginal health by following participants over several menstrual cycles. The study uses a randomized crossover design without a dedicated control group, allowing each participant to use all three products in different orders. Participants will be randomly assigned to one of six sequences, each involving the use of tampons, cups, and pads for two menstrual cycles each. This means each participant will use each product for about two months, totaling six months of study participation. Self-sampling kits will be provided, containing swabs for collecting vaginal microbiome samples at three points during each menstrual cycle. Participants will collect vaginal swab samples themselves during their menstrual cycles and provide self-reported information on vaginal health complaints monthly. Researchers will analyze various measures such as the balance of specific bacteria, vaginal pH, bacterial diversity, and molecular biomarkers. These assessments will occur monthly throughout the six-month study. This detailed monitoring aims to reveal how menstrual products impact vaginal bacterial communities and overall vaginal health.