Kericho

Researchers are evaluating the long-term safety and effects of etavopivat, a new oral medicine being developed for inherited blood disorders such as sickle cell disease and thalassaemia. These conditions affect haemoglobin, the protein responsible for carrying oxygen in the blood. This phase 3 study involves participants who have already completed treatment in a prior etavopivat study and aims to understand how etavopivat performs over an extended period of up to 264 weeks, though the study may end earlier if the drug gains approval locally. Participants will receive oral doses of etavopivat, with different forms A, B, or C given based on their age and condition. Those aged 12 years and older will receive etavopivat A or C, while children under 12 years will receive etavopivat B. The study includes several groups covering various sickle cell disease and thalassaemia categories, including transfusion-dependent and non-transfusion-dependent cases. Treatment is continuous during the study period. Throughout the study, participants will undergo regular monitoring for side effects and treatment responses, including tracking treatment emergent adverse events, hospitalizations, vaso-occlusive crises, hemoglobin concentration changes, and blood transfusion needs. These assessments will help evaluate the drugs safety and efficacy across age groups and disease types. The study is open-label and non-randomized, with follow-up lasting up to about six years.

Researchers are evaluating the pharmacokinetics and safety of etavopivat in children with sickle cell disease SCD. This phase 12 open-label study involves pediatric participants divided into four age groups, starting with the oldest and moving sequentially to younger cohorts after reviewing safety and pharmacokinetic data. The study aims to understand how the drug behaves in the body and its safety profile in this pediatric population. Participants will receive oral tablets or granules of etavopivat once daily. Each age group, ranging from 6 months to under 18 years, will be treated for a 24-week primary treatment period. Following this, participants will enter a 72-week extension treatment phase to further assess long-term safety and pharmacokinetics. The total duration for each participant is approximately 96 weeks. During the study, participants will undergo various assessments including measuring drug levels in the blood and monitoring for adverse events throughout the 24-week primary treatment and 72-week extension periods. Researchers will also evaluate hemoglobin response, changes in vaso-occlusive crisis frequency, fatigue levels, and blood flow velocity by ultrasound at multiple time points. Safety monitoring and dose adjustments will be tracked, and participants will be followed closely to understand the long-term effects of etavopivat.

Researchers are conducting an observational study called the Multinational Observational Cohort of HIV and Other Infections MOCHI to understand the number of new HIV infections among people vulnerable to acquiring HIV. This study is carried out across multiple international sites and focuses on individuals aged 14 to 55 years who engage in behaviors that increase their risk of HIV. It aims to gather information on HIV incidence as well as other sexually transmitted infections STIs. The study is divided into two steps. Step 1 enrolls participants aged 14 to 55 years who are vulnerable to HIV and evaluates them every 12 weeks for HIV and other STIs. Participants diagnosed with HIV in Step 1 move to Step 2, where they receive more frequent evaluations including viral load and other HIV-related tests every four weeks for 12 weeks, then every 12 weeks, with a total follow-up of 48 weeks in Step 2. Participants will attend regular visits for testing and evaluation throughout the study period. In Step 1, evaluations occur every 12 weeks, while in Step 2, participants have more frequent visits for detailed monitoring of their HIV status and viral load. Researchers will measure HIV incidence, STI prevalence, and willingness to participate over a 10-year period. The study includes collecting information on risk behaviors and monitoring participants health through laboratory tests and questionnaires.

Researchers are evaluating the safety and how the body processes two potent, broadly neutralizing anti-HIV monoclonal antibodies, PGT121.414.LS and VRC07-523LS, in newborn infants exposed to HIV-1. This open-label, phase I study focuses on newborns at increased risk of HIV infection and aims to understand the safety and drug levels of these antibodies when given alone or together soon after birth. Participants receive one or two subcutaneous injections of PGT121.414.LS alone or combined with VRC07-523LS. Doses are given at birth based on the infants weight, with a possible second dose at Week 12 if the infant is still breastfeeding. The study includes different groups based on feeding method and antibody combinations, with drug levels and safety assessed through Week 24. During the study, infants undergo medical evaluations including laboratory tests for blood counts and liver enzymes, physical exams, and monitoring for adverse events. Researchers measure drug concentrations and antibody levels up to Week 48 or Week 60, checking for any side effects or signs of HIV infection. Participation lasts up to about two years, allowing thorough safety and pharmacokinetic monitoring.

Researchers are evaluating the safety and tolerability of two experimental antibodies, MGD014 and MGD020, combined with antiretroviral therapy ART in people living with HIV. The study also looks at the effects of adding Vorinostat, an oral medication that helps expose hidden HIV in cells, or temporarily stopping ART to understand their impact on non-active HIV. This phase 1, pilot, open-label study aims to compare these treatment approaches and measure how long the antibodies stay in the body. Participants will be randomly assigned to one of three groups. All receive four doses of MGD014 and MGD020 by intravenous infusion over several weeks. One group continues ART with the antibodies, another stops ART temporarily while receiving the antibodies, and the third group receives the antibodies plus Vorinostat taken orally every 72 hours in two treatment cycles. The infusions and oral medication schedules vary by group, spanning about 8 months with 13 to 18 visits depending on the assigned arm. During the study, participants undergo regular clinical assessments including safety labs, viral load, and CD4 cell counts. Blood samples are collected for detailed virologic and immunologic testing. An independent safety monitor reviews safety data throughout the trial. The main outcomes measured are adverse events related to the treatments and completion of the full course. Pharmacokinetics of the antibodies and formation of anti-drug antibodies are also monitored over time.

This research aims to compare a six-month treatment plan using higher doses of rifampicin, isoniazid, linezolid, and pyrazinamide with the World Health Organizations standard nine-month treatment for tuberculous meningitis TBM in adults and adolescents. Tuberculous meningitis is a serious condition with high risk of death and severe neurological problems. This Phase II, randomized, open-label trial seeks to evaluate if the shorter high-dose regimen can improve functional outcomes compared to the standard care.

Researchers are evaluating new drug combinations for treating adults with drug-susceptible pulmonary tuberculosis TB in this Phase 2 randomized trial. The study aims to compare the early effectiveness and safety of these novel regimens against the current standard treatment, which includes isoniazid, rifampicin, pyrazinamide, and ethambutol. The main goal is to see if these new treatments improve early bacterial clearance and maintain acceptable safety over an 8-week period. Participants will be assigned to receive one of several drug regimens during the first 8 weeks. These include the standard treatment or experimental combinations containing bedaquiline, pretomanid, linezolid, TBI-223, or sutezolid at various doses. After the initial 8 weeks, all participants continue with standard therapy for an additional 18 weeks. Medication is taken orally daily, with dosing adjusted by weight and specific guidelines. During the 52-week study, which covers the full treatment and follow-up period, participants will have regular assessments including sputum tests to measure bacterial growth, blood tests to monitor safety, and clinical evaluations. The main outcomes measured are changes in bacterial growth over the first 6 weeks and the occurrence of significant side effects by week 8. Additional measurements include culture conversion rates, adverse events up to week 26, and overall cure rates at 52 weeks. Participants will be closely monitored throughout for safety and treatment response.

Researchers are exploring the effects of early intensive antiretroviral therapy ART, with or without broadly neutralizing antibodies bNAbs, on achieving HIV remission in infants living with HIV. The study includes two groups infants born to mothers with presumed or confirmed HIV infection who received little or no antiretrovirals during pregnancy, and infants diagnosed with HIV within 48 hours of birth who start ART early. This study is a Phase III proof of concept trial aiming to evaluate treatment strategies that may reduce HIV RNA to undetectable levels in infants. The trial assesses seven different intensive therapy regimens combining two nucleoside reverse transcriptase inhibitors NRTIs with other drugs such as nevirapine NVP, lopinavirritonavir LPVr, raltegravir RAL, dolutegravir DTG, and monoclonal antibodies like VRC01 and VRC07-523LS. Participants receive these regimens based on their cohort and specific treatment plan. The study is conducted in four steps initial evaluation and treatment initiation within 48 hours of birth, ongoing treatment for up to 192 weeks with assessments for viral suppression, possible analytic treatment interruption with close monitoring for viral rebound, and re-initiation of ART with monitoring until five years of age or six months after viral suppression. Participants are closely monitored throughout the study with HIV testing, safety assessments, and adherence evaluations. Researchers measure outcomes such as the number of participants achieving HIV remission by Week 48, viral suppression rates, eligibility and response to treatment interruption, and adverse events related to the study treatments. Safety monitoring continues during treatment interruption and after re-treatment. The total participation duration can extend up to five years to assess long-term effects and viral control.