Kericho

Researchers are evaluating the long-term safety and effectiveness of etavopivat, a new oral medicine being developed to treat inherited blood disorders such as sickle cell disease and thalassemia. These disorders affect hemoglobin, the protein responsible for carrying oxygen in the body. This phase 3 study aims to monitor how well etavopivat works and its safety profile over an extended period. Participants will receive one of three forms of etavopivat (A, B, or C) as oral doses. The study is open-label and multicenter, involving adults, adolescents, and children who have previously completed treatment in an etavopivat parent study and continue to benefit clinically. The treatment period can last up to 264 weeks but may end earlier if etavopivat is approved in the participant's country. During the study, researchers will track the number of treatment-emergent adverse events and adverse reactions for each participant by indication and age group from baseline through the end of the study, which can last up to 316 weeks. Participants' safety and response to long-term treatment will be closely monitored throughout this period.

Researchers are evaluating etavopivat, a once-daily oral medicine, in children and adolescents with sickle cell disease. This phase 1/2 study aims to understand the safety of etavopivat and how it behaves in the bloodstream, while also exploring potential benefits for patients. The study focuses on pediatric patients aged from 6 months to under 18 years with confirmed sickle cell disease and severe symptoms. Participants will receive etavopivat tablets by mouth once daily for a continuous 96-week treatment period. After completing treatment, there will be a final study visit four weeks later to assess any lasting effects. The study includes monitoring drug levels in the blood at various points to measure how etavopivat is processed by the body. During the study, participants will have regular assessments to monitor safety and treatment effects, including lab tests to measure drug concentration, and tracking of any side effects or adverse events. Researchers will observe the number of dose changes, interruptions, and early discontinuations throughout the 24-week primary period and beyond. The total study duration includes the 96-week treatment and a 4-week follow-up, with comprehensive monitoring of health status and medication impact.

Researchers are evaluating the safety and effectiveness of pramipexole extended release (ER) compared to escitalopram for treating major depressive disorder (MDD) and MDD with mild neurocognitive disorder (MND) in people living with HIV. This phase II, randomized, open-label trial includes an optional sub-study with 36 participants to assess treatment effects on cerebrospinal fluid (CSF) profiles. Participants will be carefully monitored to track treatment response and any side effects. Participants will take either pramipexole ER tablets or escitalopram tablets, both taken orally. The study includes scheduled visits for detailed and brief assessments throughout treatment to check for toxicity, response, and dose adjustments as needed. The sub-study for CSF evaluation is optional and involves a smaller group of participants. During the study, participants will undergo evaluations including the Beck Depression Inventory-II to measure changes in depression symptoms from the start to week 24. Researchers will also monitor for any severe or neuropsychiatric adverse events related to the study drugs throughout the 24 weeks. Participants will be assessed regularly to ensure safety and to observe treatment effects over the study period.

Prospective observational cohort study of participants vulnerable to HIV, conducted in three Steps. Step 1 will enroll participants aged 14-55 years who are vulnerable to contracting HIV. They will be evaluated every 12 weeks for HIV and other sexually transmitted infections (STIs). Participants who are diagnosed with HIV will proceed to Step 2, with evaluation of viral load and other HIV-related tests every four weeks for 12 weeks and then every 12 weeks for a total of 48 weeks. Participants who achieve and maintain viral suppression in Step 2 will proceed to Step 3 for continued HIV monitoring every 24 weeks to document maintenance of viral suppression and maintain engagement with the study site for potential future recruitment into interventional studies, including clinical trials of novel strategies to achieve HIV remission.

Researchers are evaluating the safety and how the body processes two potent, broadly neutralizing anti-HIV monoclonal antibodies called PGT121.414.LS and VRC07-523LS. The study focuses on infants exposed to HIV-1 and aims to understand the effects of these antibodies when given soon after birth. This is an open-label, phase I trial designed to explore safety and pharmacokinetics of these treatments alone and in combination. The study involves administering one or two subcutaneous doses of PGT121.414.LS alone or combined with VRC07-523LS, given as injections in the thigh. The one-dose group is followed through 12 weeks, and the two-dose group through 24 weeks. The treatments are given soon after birth, with careful timing to assess how the drugs behave in the infants’ bodies over time. Participants will be closely monitored through regular assessments including laboratory tests and physical exams to watch for any adverse effects and to measure drug levels in the blood. The main outcomes include tracking serious side effects and studying the concentration and timing of the antibodies in the infants’ system up to 48 weeks. The total study period covers safety and pharmacokinetic evaluations spanning from birth to 24 weeks or longer depending on the dosing schedule.

Researchers are evaluating the safety and tolerability of two experimental antibodies, MGD014 and MGD020, in people with HIV (PWH) who are taking antiretroviral therapy (ART). This phase 1, open-label study also examines the effects of adding a latency reversal agent, Vorinostat, or temporarily stopping ART to understand how these treatments impact dormant HIV in cells and how long the antibodies stay in the body. The study aims to compare these approaches to identify potential ways to expose hidden HIV for better treatment. Participants are randomly assigned to one of three groups. All receive four intravenous infusions of MGD014 and MGD020 at 300 mcg/kg over 60 minutes. Group A continues their ART and receives infusions every 2 weeks. Group B receives the same infusions but stops ART for up to 8 weeks under close monitoring. Group C continues ART, receives the antibody infusions on a different schedule, and takes Vorinostat orally at 400 mg every 72 hours in two cycles spanning weeks 0 to 4 and weeks 8 to 12. The total participation time is about 8 months with 13 to 18 visits depending on the group. Throughout the study, participants undergo regular clinical evaluations including safety lab tests, viral load measurements, and CD4+ cell counts. Samples are collected for detailed virologic and immunologic studies to assess viral activity and drug levels. An independent safety monitor reviews all safety and clinical data regularly. Primary outcomes measured include the percentage of participants experiencing significant adverse events related to the treatments and the proportion completing the full treatment course.

Researchers are investigating a shorter, 6-month treatment regimen using high doses of rifampicin, isoniazid, linezolid, and pyrazinamide compared to the World Health Organization's standard 9-month treatment for tuberculous meningitis (TBM), a serious brain infection with high risk of death and severe neurological problems. This Phase II, randomized, open-label trial aims to evaluate the safety, drug levels, and long-term outcomes of this intensified 6-month therapy versus the standard treatment. Participants include adults and adolescents diagnosed with TBM, with treatment groups balanced by HIV status and disease severity.

Researchers are evaluating new drug regimens for treating adults with drug-susceptible pulmonary tuberculosis (TB) in a Phase 2 adaptive, randomized, controlled, open-label trial. The study aims to determine if these novel treatments provide better early effectiveness compared to the standard combination of isoniazid, rifampicin, pyrazinamide, and ethambutol. The safety and tolerability of these regimens will also be assessed over an 8-week treatment period. Participants will receive one of several drug combinations, including standard therapy with isoniazid, rifampicin, pyrazinamide, and ethambutol, or experimental regimens containing drugs like bedaquiline, pretomanid, linezolid, TBI-223, and sutezolid. Dosing varies by drug, with most taken orally once daily, often with meals. The initial 8 weeks constitute the study treatment phase, followed by an 18-week continuation phase of standard care, making the total treatment duration 26 weeks. Throughout the study, participants will undergo regular assessments, including sputum cultures to measure bacterial growth rates during the first 6 weeks and monitoring for any serious side effects by week 8. Laboratory tests, chest x-rays, and performance scores will be used to evaluate health status. Participants will be followed for a total of 52 weeks, ensuring safety and treatment effectiveness are closely monitored.

Researchers are exploring how very early intensive antiretroviral therapy (ART), with or without a broadly neutralizing antibody (bNAb), may help infants living with HIV achieve HIV remission, defined as having HIV RNA levels below the detection limit of the test. This Phase I/II study focuses on infants born to mothers with presumed or confirmed HIV infection and aims to evaluate the impact of starting treatment within 48 hours of birth. The study includes two groups: infants born to mothers who received little or no antiretrovirals during pregnancy, and infants confirmed HIV positive shortly after birth who started ART quickly. The study tests seven different intensive therapy regimens involving combinations of nucleoside reverse transcriptase inhibitors (NRTIs), nevirapine (NVP), lopinavir/ritonavir (LPV/r), raltegravir (RAL), dolutegravir (DTG), and monoclonal antibodies VRC01 or VRC07-523LS. Treatments are given orally or by subcutaneous injection depending on the drug. The study is conducted in four steps: initial enrollment and evaluation within 48 hours of birth (Step 1), up to 192 weeks of ART treatment with monitoring and possible treatment interruption if virus suppression is achieved (Step 2), close monitoring during treatment interruption for up to five years (Step 3), and re-initiation of ART with ongoing monitoring if the virus returns or other criteria are met (Step 4). Participants will be closely monitored throughout the study with regular HIV testing, physical exams, and assessments of immune health. Safety monitoring will continue for infants who do not have confirmed infection but received initial treatment. Children who maintain viral suppression will undergo analytic treatment interruption and be followed for viral rebound. Outcome measures include the number of participants who reach HIV remission by week 48. The study may last up to five years for some participants, including long-term follow-up through re-treatment and viral monitoring.