Santo Domingo

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 the safety, how the body absorbs, and the effect on hormone regulation of a topical lotion called IDP-122 containing halobetasol propionate in children aged 6 to 16 years with moderate to severe plaque psoriasis. The study aims to understand how this lotion affects young patients, especially regarding its impact on the hypothalamic-pituitary-adrenal HPA axis, which controls stress hormone levels. Two groups of pediatric participants, one aged 12 to 16 years 11 months and the other aged 6 to 11 years 11 months, will apply IDP-122 Lotion once daily to psoriasis lesions covering at least 10% of their body surface area. This treatment will continue daily for 8 weeks, with the lotion applied to specific sites identified by the investigator. Participants will undergo blood tests to measure the maximum concentration of the drug in their plasma at various times after dosing. Researchers will also monitor for signs of HPA axis suppression at Week 8. The study involves regular assessments to track safety and systemic exposure, with a total participation period that includes these 8 weeks of treatment and monitoring.

Researchers are evaluating the consistency of immune responses to three different batches of an investigational chickenpox vaccine called VNS vaccine in healthy children aged 12 to 15 months who have not had chickenpox or received a chickenpox vaccine before. The study also compares the safety and immune response of the VNS vaccine to an approved chickenpox vaccine known as Varivax. This Phase 3a study is sponsored by GlaxoSmithKline and aims to better understand the immune protection provided by these vaccines. Participants are randomly assigned to receive one dose of either one of the three investigational VNS vaccine lots or one of two lots of the marketed Varivax vaccine. Along with the chickenpox vaccine, they also receive one dose each of measles, mumps, and rubella MMR vaccine, hepatitis A vaccine HAV, and a pneumococcal conjugate vaccine PCV which could be PCV 13, Vaxneuvance, or PCV 20 depending on availability and country recommendations. All vaccines are given on Day 1 of the study. During the study, researchers monitor the participants immune responses by measuring antibodies against varicella zoster virus VZV and other vaccine components at Day 43. They also track safety by recording any side effects or adverse events from Day 1 to Day 181. The study includes diary reports by parents and regular clinical evaluations to assess immune response and safety outcomes. Participation involves a single vaccination visit and follow-up assessments over approximately six months.

This research aims to evaluate the immune response and safety of an investigational chickenpox vaccine VNS Vaccine compared to an already approved vaccine called Varivax VV. The study focuses on healthy children who have not previously had chickenpox or received a chickenpox vaccine, and takes place when the second dose is given three months after the first dose, which is administered between 12 and 15 months of age. Participants are randomly assigned to one of three groups one group receives two doses of the Varivax vaccine another group receives two doses of the investigational VNS vaccine and the third group receives a first dose of Varivax followed by a second dose of the VNS vaccine. Additional vaccines including measles, mumps, and rubella MMR, hepatitis A HAV, and pneumococcal conjugate vaccine PCV are given on the first day. In some countries, a second dose of MMR is also given between 15 and 18 months according to national guidelines. During the study, researchers will monitor immune responses by measuring specific antibodies against the chickenpox virus after the second dose, particularly 43 days post-vaccination. They will also track any local or systemic side effects following each vaccine dose, recording adverse events up to nearly nine months after the first dose. The total participation includes multiple visits over this time, ensuring detailed safety and immune response assessment for each child.

Researchers are evaluating Afimkibart RO7790121 for people with moderately to severely active Crohns disease. This Phase III clinical trial aims to assess the effectiveness and safety of both induction and maintenance therapy using this drug compared to a placebo. The study is designed as a double-blind, placebo-controlled trial across multiple centers. Participants will be randomly assigned to one of three groups receiving either Afimkibart via intravenous infusion followed by subcutaneous injection or matching placebo treatments. The study involves continuous treatment through induction and maintenance phases to compare outcomes at weeks 12 and 52. The trial includes a placebo group to provide a comparison for evaluating Afimkibarts effects. During the study, participants will have regular visits for assessments including clinical remission rates, endoscopic response, symptomatic remission, stool frequency, abdominal pain, and quality of life questionnaires. Researchers will monitor various outcomes over 52 weeks and track adverse events for up to 70 weeks after baseline. This long-term follow-up helps evaluate both the treatments impact and safety throughout the trial period.

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

Researchers are studying children and adolescents aged 10 to 19 with high-risk type 1 diabetes in the Dominican Republic to see if intermittent use of the Dexcom G7 continuous glucose monitor CGM, combined with pediatric endocrinology follow-up, diabetes education, and psychological support, can improve glucose control. This pilot longitudinal study involves 40 participants from two pediatric diabetes care centers. Participants will use the Dexcom G7 CGM during two short monitoring periods early in the study, using six sensors in total. Between and after these monitoring periods, they will return to their usual finger-stick glucose monitoring with a glucometer. In addition, participants and their families will attend scheduled medical visits, diabetes education sessions, and psychological support sessions throughout the study. During the study, information will be collected from medical records, lab results, Dexcom Clarity reports, participant glucose logs, study forms, and questionnaires. Researchers will assess changes in HbA1c, time spent in glucose target range, average glucose levels, glucose variability, episodes of low and high blood glucose, adverse events, diabetes-related distress, fear of hypoglycemia, and satisfaction with glucose monitoring. The study lasts for 12 months with regular follow-up and support visits.

Researchers are conducting an international, multicenter observational study to understand acute kidney injury requiring renal replacement therapy AKI-RRT in Latin American countries. The study focuses on the epidemiology, outcomes, and care processes for patients with AKI-RRT, comparing variations across different countries and examining factors such as demographics, clinical profiles, and socioeconomic status that may influence patient outcomes. The aim is to establish a comprehensive database to support clinical research and improve understanding of AKI-RRT in this region. The study observes critically ill adult patients admitted to intensive care units ICUs who are undergoing any form of renal replacement therapy. It collects detailed clinical, laboratory, treatment, and outcome data without assigning treatments, as it is observational. Patients are followed from enrollment through hospital discharge or up to 90 days, including ICU stay and 90-day post-ICU follow-up to track mortality, renal recovery, and complications related to renal replacement therapy. Participants involvement includes monitoring during ICU and hospital stays with data collected on mortality rates, length of stay, renal function recovery, dependence on renal replacement therapy, and complications such as infections or anticoagulation issues. The primary outcome measured is in-hospital mortality, with secondary outcomes covering ICU mortality, 90-day mortality, length of stay, recovery, and procedural complications. This study spans from enrollment until 90 days after ICU admission, providing extensive observational data on AKI-RRT in Latin America.

Researchers are evaluating the safety and usability of a new intraocular lens IOL called AAL-FAIOL for adults who need cataract surgery in both eyes. The study is conducted in Central America and aims to compare the AAL-FAIOL lens with another lens called BAL-FAIOL. The goal is to explore how well these lenses work and how safe they are for long-term use after cataract removal. Participants will have cataract surgery in both eyes, with one eye receiving the AAL-FAIOL lens and the other eye receiving the BAL-FAIOL lens. The surgeries in the two eyes will be scheduled 14 to 35 days apart. The AAL-FAIOL lens can be adjusted after surgery using laser treatment if needed to improve vision. Both lenses are implanted during cataract surgery using a technique called phacoemulsification. During the study, participants will attend follow-up visits for about one year to monitor their eye health and vision. Researchers will check for any eye-related adverse events or complications, including any additional surgeries needed. The study will measure the overall safety of the lenses and how well participants do over this 12-month period after their surgeries.

Researchers are tracking the natural history and clinical outcomes of patients with Gaucher disease through the ICGG Gaucher Registry, an international, multi-center observational program. This registry does not involve any experimental treatments, but collects information to better understand the variability, progression, and identification of Gaucher disease, aiming to improve patient care and therapeutic guidance. It also evaluates the long-term use of treatments like imiglucerase and eliglustat. The study includes two groups patients with Gaucher disease who receive routine clinical assessments and standard care as determined by their physicians, and a Pregnancy Sub-registry for women with Gaucher disease who are pregnant or have been pregnant. The Pregnancy Sub-registry collects information on pregnancy outcomes, complications, and infant growth up to 36 months postpartum, regardless of whether the women receive disease-specific therapy. Participants undergo clinical assessments and receive care according to their treating physicians decisions. Data collected includes medical history, pregnancy and birth details for the sub-registry, and patient outcomes over time. The primary goals are to provide recommendations for monitoring Gaucher disease patients, report outcomes to optimize care, and track pregnancy and infant growth outcomes. This ongoing registry allows long-term follow-up without experimental interventions.