Ibadan

Researchers are studying etavopivat, a new medicine, in children aged 12 to 16 years with sickle cell disease who have an increased risk of stroke. The trial focuses on patients with conditional or abnormal transcranial doppler TCD ultrasound results, assessing whether etavopivat is safe and helpful for these participants. The study is a Phase 2 open-label trial sponsored by Forma Therapeutics, Inc., aiming to understand the effect of etavopivat on blood flow velocities in brain arteries. Participants will be divided into two groups based on their TCD results and whether they are already taking the medication hydroxyurea. One group includes participants with abnormal or conditional TCD who are not on hydroxyurea, while the other group includes those with similar TCD results who are on a stable dose of hydroxyurea. All participants will take 400 mg of etavopivat orally once daily for 52 weeks, with the option to continue in a 48-week extension period to further monitor safety. Etavopivat is taken as two 200 mg tablets and may be taken with or without food. During the study, participants will visit the clinic frequently for monitoring. Assessments include measuring blood flow velocities in brain arteries using TCD at various time points, tracking changes in velocity categories, and monitoring safety. The study also includes evaluating blood counts and liver and kidney function. At the end of the treatment and extension periods, participants may be offered the chance to join another study to continue receiving etavopivat. Total participation can last up to about two years depending on extension and further studies.

Researchers are evaluating the safety, tolerability, effectiveness, and how the body processes and responds to osivelotor in people with sickle cell disease SCD. This multicenter, Phase 23 study focuses on both adults and adolescents with SCD, aiming to determine the best dose and assess the drugs effects over time. The study has three parts. Part A tests safety, tolerability, and dose-finding in adults with SCD, starting with randomization to different daily doses of osivelotor, ranging from 100 mg to potentially 200 mg, over 12 weeks. Part B compares osivelotor to placebo in adults and adolescents over 48 weeks, with adults receiving an initial 300 mg daily dose for 7 days followed by 150 mg daily, while adolescent dosing will be defined later. The Open Label Extension OLE offers long-term open-label osivelotor treatment for up to two years after Part B. Participants will be monitored throughout the study with regular visits to assess safety, blood responses, and how well they tolerate the medication. The main results will be reviewed through 12 weeks in Part A, 48 weeks in Part B, and approximately 24 months in the OLE. The study includes blood tests, monitoring of vaso-occlusive crises, and other health evaluations to understand osivelotors effects and safety over time.

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 effects of etavopivat in adolescents and adults with sickle cell disease. This study aims to confirm whether etavopivat reduces the number of painful vaso-occlusive crises caused by blood vessel blockages. It also examines if the medicine helps reduce organ damage, improve exercise tolerance, and decrease fatigue. The study is a phase 3, randomized, double-blind, placebo-controlled trial lasting about two years. Participants will be randomly assigned to receive either oral etavopivat or a placebo. The treatment is given by mouth, and neither the participants nor the researchers know which treatment is given during the study to ensure impartial results. The primary treatment period is 52 weeks, during which the number of vaso-occlusive crises with medical contact will be measured. Secondary assessments include changes in hemoglobin levels, fatigue scores, walking distance, and other blood markers related to sickle cell disease. During the trial, participants will undergo regular evaluations including blood tests, walking tests, and fatigue assessments from baseline to week 52. Researchers will monitor the safety and effectiveness of etavopivat throughout the study. The total participation time is about two years, with ongoing follow-ups to observe the treatment effects and any side effects. All procedures aim to provide detailed information on how etavopivat affects sickle cell disease symptoms and patient well-being.

This research aims to evaluate cancer treatment based on HER2 status in Nigerian women with HER2-positive breast cancer. The study focuses on assessing the safety and effectiveness of anti-HER2 therapy given before and after surgery. It specifically looks at how well the treatment works and its safety when combined with chemotherapy. Participants will receive a combination of trastuzumab and pertuzumab PHESGO along with chemotherapy. Initially, all participants get docetaxel injections for 4-6 cycles while receiving trastuzumab and pertuzumab as subcutaneous injections for 52 weeks. Depending on how their cancer responds after this phase, some will undergo surgery and continue receiving pertuzumab and trastuzumab for 36 weeks, possibly with hormone therapy such as tamoxifen, letrozole, or goserelin. Others with less favorable responses will receive trastuzumab emtansine intravenously plus standard chemotherapy. During the study, participants will have regular assessments including ultrasounds to monitor tumor response, laboratory tests, and echocardiograms to check heart function. Researchers will track outcomes like pathological complete response, adverse events, quality of life, and survival over 10 years. The study involves continuous monitoring and follow-up to evaluate treatment effects and safety throughout this period.

Tuberculosis TB is a serious infectious disease caused by Mycobacterium tuberculosis, leading to millions of cases and deaths worldwide, particularly in developing countries like Nigeria. TB mainly affects the lungs and is worsened by HIV infection, making it a top cause of death globally. The trial investigates atorvastatin, a cholesterol-lowering drug, to see if it can improve TB treatment by reducing bacteria and lung damage, building on promising earlier studies that showed atorvastatin was safe and may enhance TB therapy outcomes. The trial is a phase IIC, multicenter, randomized, open-label study comparing four treatment groups three different daily doses of atorvastatin 20mg, 40mg, 60mg given for 16 weeks along with standard 6-month anti-TB therapy, and a control group receiving standard therapy alone. Patients are randomly assigned to one of these groups and followed closely for 12 months after starting treatment. The study aims to evaluate safety, the speed at which TB bacteria clear from sputum, improvement in chest X-rays, and lung function. Participants aged 12 to 65 with active pulmonary TB will undergo screening including medical history, HIV and diabetes testing, sputum cultures, blood tests, lung function, and pregnancy tests for women. During the study, sputum samples, blood tests, chest X-rays, and lung function will be monitored regularly. Researchers will track side effects and measure outcomes like TB disease-free survival and symptom improvement at 6 and 12 months. The long follow-up period allows for detailed assessment of treatment effects and safety.

Young people living with HIV Y-PLWH often face psychological distress and depression, which negatively affect their medication adherence and disease control. This issue is especially challenging in low- and middle-income countries like Nigeria, where there are few trained mental health professionals and frequent clinic visits can cause additional costs, inconvenience, and stigma. Researchers are evaluating an interactive narrative game called Change My Story combined with Problem Solving Therapy PST compared to PST alone in a pilot randomized controlled trial among 80 Y-PLWH with depression or psychological distress. Participants will be assigned to one of two groups one group will receive PST alone delivered through a stepped-care approach with therapy sessions and follow-up based on depression scores, while the other group will receive PST plus access to the Change My Story game on their phones. The game encourages weekly play and helps address key drivers of psychological distress through interactive narratives. Participants in both groups will be monitored for depression, suicidality, and treatment response, with referrals to medical or psychiatric care if needed. During the study, participants will engage in therapy sessions, complete depression screenings, and report on their engagement, satisfaction, and feasibility of the interventions over three months. Outcomes measured include remission of depression and psychological distress, antiretroviral therapy adherence, and viral suppression at 3 and 6 months. The trial aims to assess acceptability, engagement, and barriers to implementation of the game combined with PST. The total study duration is up to 6 months with ongoing evaluation of mental health and HIV care outcomes.

This research aims to adapt and test a combined peer navigation and mobile health mHealth approach called the Intensive Combination Approach to Rollback the Epidemic in Nigeria iCARE Nigeria. It focuses on improving HIV treatment engagement, medication adherence, and viral suppression among young men who have sex with men YMSM and young transgender women YTW aged 15 to 29 years in Nigeria. The study evaluates the initial effectiveness and feasibility of this intervention in community settings tailored for these key populations. Participants will be randomly assigned to one of two groups one receiving the combination peer navigation and SMS text message medication reminders intervention, and the other receiving the standard of care. The intervention is adapted for community-based outreach and delivered over a 24-week period. The study will assess viral load suppression and other treatment-related outcomes at baseline and after 24 weeks. During the study, participants will be monitored for HIV viral load suppression, retention in HIV care, medication adherence, and the feasibility and acceptability of the intervention. Data will be collected through medical record reviews and participant feedback. The total duration of participation is 24 weeks, during which researchers will also evaluate aspects of implementation to inform future sustainability and scalability of the intervention.

This research aims to improve cervical cancer screening and follow-up care for women living with HIV WLWH in Nigeria. It focuses on adapting and implementing a home-based screening program using the MoMent peer support model to better reach and support this high-risk group. The study evaluates how well the program works, how widely it is adopted, and its long-term sustainability. The study will adapt the MoMent program, which pairs experienced WLWH called Mentor Mothers with newly diagnosed women, to include home-based HPV screening using the GeneXpert HPV test. Women who test positive for high-risk HPV types receive follow-up care, including visual inspection with acetic acid VIA and treatment such as thermal ablation or excision if needed. Those testing negative are invited for retesting after one year. The programs reach, effectiveness, adoption, and fidelity will be assessed over 18 months. Participants will self-collect vaginal samples at home, and Mentor Mothers will assist in notifying and scheduling follow-up care for those with positive results. The study includes questionnaires and process evaluations to identify barriers and facilitators. The main outcomes measured are program reach, effectiveness, adoption, and fidelity at baseline, 6 months, and 18 months. The study runs from December 2024 to June 2026 and focuses on women aged 25 to 50 living with HIV.

Researchers are studying the safety and drug levels of dolutegravir given twice daily in children aged 4 weeks to under 6 years who have both HIV and tuberculosis TB. The study focuses on how dolutegravir works when taken with standard and higher doses of rifampicin, a TB medicine, since current rifampicin doses may be too low for children. This research aims to better understand treatment effects and improve outcomes in this vulnerable group. Children in this study will receive HIV and TB treatments according to current care standards. For weeks 20 and 21, the dose of rifampicin will be increased to a higher level to observe how it affects dolutegravir levels and safety. Blood samples will be collected during weeks 20, 22, and 30 to measure drug concentrations and assess biomarkers related to drug processing in the body. Participants will be monitored through clinical and laboratory tests over a 48-week period. Blood samples will be taken multiple times to assess drug levels and a specific biomarker to understand drug effects better. Safety will be closely followed, especially during the higher rifampicin dose period. The main outcomes include measuring dolutegravir exposure during standard and high-dose rifampicin and monitoring for any serious adverse events by week 48.