[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622098":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":17,"centralContacts":17,"locations":17,"responsibleParty":27,"collaborators":29,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":42,"eligibilityCriteria":43,"healthyVolunteers":38,"sex":44,"minAge":45,"maxAge":17,"enrollmentInfo":46,"targetDuration":17,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":59,"whyStopped":17,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":17},{"fullName":5,"class":6},"Wits Health Consortium (Pty) Ltd","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Valganciclovir","EXPERIMENTAL","Valganciclovir 900mg daily for 28 days",[13],"Drug: Valganciclovir",{"label":15,"type":16,"description":17,"interventionNames":18},"Arm B","PLACEBO_COMPARATOR",null,[19],"Drug: Placebo",[21,24],{"type":22,"name":9,"description":9,"armGroupLabels":23,"otherNames":17},"DRUG",[9],{"type":22,"name":25,"description":25,"armGroupLabels":26,"otherNames":17},"Placebo",[15],{"type":28,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR",[30,32,34],{"name":31,"class":6},"Infectious Diseases Institute, Uganda",{"name":33,"class":6},"London School of Hygiene and Tropical Medicine",{"name":35,"class":6},"St George's, University of London","100622098","phase-2-valganciclovir-for-cmv-viraemia-in-advanced-hiv-disease-100622098",false,"NCT07379203","ValgaNciclovIR for CMV Viraemia in AdvaNced HIV diseAse","A Phase 2b Randomised Placebo Controlled Trial of Valganciclovir for Cytomegalovirus Viraemia in Adults and Adolescents With Advanced HIV Disease","NIRVANA","Inclusion Criteria:\n\nConfirmed HIV infection CD4 count ≤100 cells\u002Fmm³ Expected to survive at least 48 hours CMV viral load \\>500 international units (IU) \u002F mL in blood. Provision of informed consent\n\nExclusion Criteria:\n\nConfirmed or high level of clinical suspicion for CMV end organ disease as determined by the treating team CMV retinitis confirmed by retinal phography Pregnancy or breastfeeding Contraindication to valganciclovir (absolute neutrophil count \\\u003C 1.0 X109\u002FL, haemoglobin \\\u003C 8 g\u002FdL, platelets \\\u003C 100 X109\u002FL) Allergy or prior adverse reaction to valganciclovir Expected to be unable to complete follow up Moribund - treating team considers patient is likely to die within next 48 hours Estimated creatinine clearance \\\u003C 40 mL\u002Fmin ALT \\> 3X ULN Receipt of high dose acyclovir as standard of care Unable to swallow whole tablets Concurrent administration of highly myelosuppressive drug, e.g. amphotericin B deoxycolate and linezolid\n\n\\-","ALL","15 Years",{"count":47,"type":48},130,"ESTIMATED","INTERVENTIONAL",[51],"PHASE2","The goal of this clinical trial is to learn if valganciclovir works to treat cytomegalovirus (CMV) infection in people with advanced HIV disease. It will also look at the safety of valganciclovir and how the body handles the drug.\n\nThe main questions this study aims to answer are:\n\nDoes valganciclovir safely lower the amount of CMV virus in the blood of people with advanced HIV disease?\n\nWhat medical problems or side effects do participants have when taking valganciclovir?\n\nResearchers will compare valganciclovir to a placebo (a look-alike tablet that does not contain any active drug) to see if valganciclovir works better than no treatment for CMV.\n\nWho can take part\n\nAdults and adolescents (15 years and older) who:\n\nAre living with HIV\n\nHave a CD4 count of 100 or less (meaning their immune system is very weak)\n\nHave CMV detected in their blood\n\nPeople who are pregnant, breastfeeding, very unwell, or have certain blood or kidney problems cannot take part.\n\nWhat will happen in the study\n\nParticipants will:\n\nBe randomly assigned (like flipping a coin) to take either valganciclovir 900 mg or a placebo once a day for 4 weeks\n\nContinue to receive standard medical care for HIV and any other infections\n\nBe followed for 12 weeks after starting the study treatment\n\nDuring this time, participants will:\n\nHave blood tests to check CMV, HIV, and general health\n\nHave regular medical check-ups (daily in hospital, then at weeks 1, 2, 3, 4, 8, and 12)\n\nBe monitored closely for side effects, such as low blood counts or kidney problems\n\nWhy this study is important\n\nEven though HIV treatment is widely available, many people still come to hospital with advanced HIV disease. In this group, about one in five people die despite starting antiretroviral therapy (ART). Reactivation of CMV is very common in these patients and has been linked to a higher risk of death.\n\nValganciclovir is a medicine that stops CMV from multiplying. If it proves to be safe and effective in this study, it could become part of routine care to help reduce deaths in people with advanced HIV disease.\n\nStudy design\n\nType: Phase 2b, double-blind, randomised, placebo-controlled trial\n\nSites: Helen Joseph Hospital (South Africa) and Mulago National Referral Hospital (Uganda)\n\nNumber of participants: 150 (130 in the main trial, 20 in a smaller sub-study)\n\nDuration: Each participant will be followed for 12 weeks; total study duration about 2 years\n\nPossible risks and benefits\n\nRisks: Valganciclovir can cause low white blood cells, anaemia, or low platelets. These effects will be checked for regularly, and treatment will be stopped if unsafe levels are found.\n\nBenefits: The study may or may not directly benefit participants. However, it could provide important information that helps improve care for people with advanced HIV disease in the future.\n\nOversight and safety\n\nThe study is being conducted by researchers in Uganda, South Africa, the UK, and the USA, and follows international Good Clinical Practice (GCP) guidelines.\n\nAn independent Data Safety and Monitoring Committee (DSMC) will regularly review safety information to protect participants.",[54],"Cytomegalovirus (CMV) Infection",[56,57,58],"Cytomegalovirus","Advanced HIV disease","valganciclovir","NOT_YET_RECRUITING","2026-01-22",{"date":62,"type":63},"2026-01-30","ACTUAL",{"date":65,"type":48},"2026-02-01",{"date":67,"type":48},"2027-06-30",{"name":5,"class":6}]