[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Witwatersrand, South Africa\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":104},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100644708","phase-4-sleep-outcomes-and-multidimensional-assessment-with-antiretroviral-therapy-in-people-living-with-hiv-on-dolutegravir--vs-doravirine-based-regimens-100644708",false,"NCT07673965","Sleep Outcomes and Multidimensional Assessment With Antiretroviral Therapy in People Living With HIV on Dolutegravir- vs Doravirine-Based Regimens","Multidimensional Sleep Health in PLWH on DTG- vs DOR-Based ART: A Mixed-Methods Pilot Study","SOMNART","Inclusion Criteria:\n\n\\-\n\nEach participant must meet all the following criteria to be enrolled in this study:\n\n1. Male or female aged 18-40 years\n2. HIV-positive\n3. Virologically suppressed, defined as HIV RNA \\\u003C50 copies\u002FmL\n4. No known history of HIV treatment failure\n5. On a stable first-line ART regimen for ≥ 12 months and TDF\u002F3TC\u002FDTG for ≥ 6 months prior to enrolment\n6. BMI \\\u003C 35 kg\u002Fm² and weight \\>35kg\n7. Women of childbearing potential must have a negative pregnancy test at screening, must use acceptable contraception throughout the study, and must not be planning pregnancy during the study period\n8. Willing and able to undergo overnight PSG as required by the protocol\n9. Clinically stable with no uncontrolled comorbidities as assessed by the investigator\n10. Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n\\-\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Planned or recent (30 days before enrolment) changes to chronic medication, or anticipated medication changes during the study period, if applicable\n2. Known contraindication to Delstrigo (hepatic impairment, hypersensitivity, strong CYP450 inducers)\n3. Previous NNRTI use or prior documented NNRTI mutations\n4. Clinical suspicion of TB\n5. Insufficient total sleep time on screening polysomnography to permit reliable interpretation of sleep parameters or to confirm or exclude a sleep disorder.\n6. Evidence of a clinically significant sleep disorder at screening, based on history, the site-specific Sleep Disorders Screening Tool (SDST) and\u002For polysomnography, including but not limited to:\n\n   1. Suspected or confirmed OSA\n   2. Suspected or known insomnia\n   3. Suspected restless legs syndrome (RLS), or periodic limb movements on PSG\n   4. Narcolepsy\n7. Use of medications known to significantly alter sleep, including (but not limited to):\n\n   1. Benzodiazepines\n   2. Non-benzodiazepine sedative-hypnotics\n   3. Antipsychotics or mood stabilisers\n   4. Antidepressants with significant sedating effects\n   5. Isoniazid\n   6. Anticonvulsants e.g. carbamazepine, phenytoin, phenobarbital\n8. Current alcohol use disorder or substance use (including illicit substances) that may interfere with sleep or study assessments, as determined by the investigator.\n9. Pregnant, breastfeeding, or planning to become pregnant during the study period, or currently nursing or caring for an infant younger than 6 months at home\n10. Active psychiatric illness that might interfere with study procedures or overnight assessments, as assessed by the investigator\n11. Regular shift work defined as working more than three nights or rotating shifts per month at baseline or during the study, or having transitioned from night-shift to day-shift duties within the past month\n12. Known or suspected significant neurological conditions that may interfere with sleep (e.g., epilepsy, neurodegenerative disorders, or a history of moderate-to-severe traumatic brain injury).\n13. Current participation in another clinical trial, observational or interventional","ALL","18 Years","40 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","In South Africa, antiretroviral therapy (ART) has transformed HIV into a chronic, manageable condition, with high rates of viral suppression. As people living with HIV (PLWH) live longer, HIV care is increasingly focused on long-term health, quality of life, and prevention of non-communicable diseases such as obesity,cardiovascular disease, and metabolic disorders, which are increasingly common in this population. Sleep disturbance is highly prevalent among PLWH but is under-recognised in routine care. Poor sleep has been associated with adverse cardiometabolic, cognitive, and functional outcomes, yet is rarely systematically assessed in HIV programmes. Most existing evidence relies on subjective measures, with limited objective polysomnography data, particularly in African populations. In addition, the impact of different ART regimens on sleep health remains poorly understood. This study aims to evaluate and compare sleep health in virologically suppressed PLWH who switch from a dolutegravir-based regimen to a doravirine-based regimen versus thosewho remain on dolutegravir-based therapy. Sleep will be assessed using a multidimensional approach, incorporating polysomnography, actigraphy, and validated patient-reported outcome measures aligned with the RU-SATED framework. The study is particularly relevant in South Africa, where dolutegravir-based regimens are widely used and where obesity and metabolic disease are increasing. In a resource-limited setting where sleep disorders are often underdiagnosed, this study will generate locally relevant evidence on the relationship between ART and sleep health, with potential implications for more holistic HIV care.",[28,29],"HIV (Human Immunodeficiency Virus)","Sleep",[31,32,33,34,35],"Delstrigo:","Sleep Health","Sleep Architecture","Antiretroviral Therapy","HIV","NOT_YET_RECRUITING","2026-06-24",{"date":39,"type":40},"2026-06-29","ACTUAL",{"date":42,"type":22},"2026-08-20",{"date":44,"type":22},"2027-11-30",{"name":46,"class":47},"University of Witwatersrand, South Africa","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100553366","phase-4-post-injectable-cabotegravir-antiretroviral-salvage-strategy-options-trial-100553366","NCT06485154","Post-Injectable Cabotegravir Antiretroviral Salvage Strategy Options Trial","PICASSO","Inclusion Criteria:\n\n1. Male or female.\n2. Age ≥ 15 years, inclusive, at the time of signing the informed consent.\n3. Body weight ≥ 35 kg.\n4. Confirmed HIV-1 infection.\n5. Exposure to at least one dose of CAB-LA PrEP in the past 12 months.\n6. Consent to initiation of ART.\n7. Estimated glomerular filtration rate (eGFR) \\> 50 min\u002FmL\n\nExclusion Criteria:\n\n1. Any previous exposure to DTG.\n2. Concurrent or recent (within the preceding 3 months) participation in another interventional clinical trial with a compound likely to interfere with any of the investigational medicinal products.\n3. Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms or similar compounds.\n4. Is receiving or has received the following agents within 28 days prior to screening, and cannot discontinue their use for the duration of the study:\n\n   1. tuberculosis therapy (i.e., rifampicin, rifapentine, rifabutin), with the exception of isoniazid (INH) prevention therapy;\n   2. anti-convulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin);\n   3. herbal products (e.g., St John's Wort).\n5. Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study or impair their ability to comply with the dosing schedule and\u002For protocol evaluations. The Investigator should make this determination in consideration of the volunteer's medical history.\n6. Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results. This including inability or an unwillingness to be followed up for the study period.","15 Years",{"count":57,"type":22},100,[25],"This is a single-arm, open-label, effectiveness study designed to evaluate the use of Tenofovir, Lamivudine, and Dolutegravir in people with newly diagnosed HIV-1 infection initiating first-line Antiretroviral Therapy with Cabotegravir-Long-acting Pre-Exposure Prophylaxis exposure in the preceding 12 months. Participants will be followed up for a period of 12 months from enrolment.",[61],"HIV Prevention",[63,64,65],"Pre-Exposure Prophylaxis (PrEP)","Antiretroviral therapy","Tenofovir Disoproxil Fumarate\u002FLamivudine\u002FDolutegravir","RECRUITING","2026-06-04",{"date":69,"type":40},"2026-06-09",{"date":71,"type":40},"2024-06-01",{"date":73,"type":22},"2026-08-31",{"name":46,"class":47},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100589539","phase-3-a-clinical-trial-on-safety-in-pregnant-women-and-how-well-the-infant-is-protected-against-rsv-associated-lower-respiratory-tract-infection-when-the-pregnant-woman-receives-the-approved-rsv-vaccine-compared-to-a-placebo-100589539","NCT06955728","A Clinical Trial on Safety in Pregnant Women and How Well the Infant is Protected Against RSV-associated Lower Respiratory Tract Infection When the Pregnant Woman Receives the Approved RSV Vaccine Compared to a Placebo.","A Phase-IIIb Individually Randomized, Placebo-controlled Trial on Safety of RSVA\u002FB-preF Vaccine in Pregnant Women and Efficacy Against Severe RSV-associated Lower Respiratory Tract Infection in Infants","Inclusion Criteria:\n\n* Pregnant women considered to be legally competent, as per country legislation, to consent for trial participation for herself and her newborn\n* At a gestational age in keeping with in-country approval of the vaccine administration, and not in active labour. Gestational age will be based on GAIA LOC 1 to 2B criteria\n* Mother is able to understand and comply with planned trial procedures\n* Mother is attending ante-natal clinic\n* Mother has documented test for HIV and syphilis during the current pregnancy,\n* Provides written informed consent prior to initiation of trial. If the maternal participant is illiterate, a witnessed thumb-printed informed consent is acceptable\n* Intention to deliver at a hospital or birthing facility where trial procedures can be obtained (for immunogenicity cohort)\n* Expected to be available for the duration of the trial and can be contacted by telephone or by physical visit during trial participation\n* Participant is willing to give informed consent for her infant to participate in the trial\n\nExclusion Criteria:\n\n* Body mass index of \\>40 kg\u002Fm2 at the time of the first obstetric visit during the current pregnancy\n* Bleeding diathesis or condition (past or present) associated with prolonged bleeding that would, in the opinion of the investigator, contra-indicate intramuscular injection\n* History of severe adverse reaction associated with a vaccine\n* Current pregnancy complications or abnormalities at the time of consent that will increase the risk associated with the participation in and completion of the trial, including but not limited to the following:\n\n  1. More than two fetuses (i.e. twins will be allowed)\n  2. Preeclampsia, eclampsia, or uncontrolled gestational hypertension\n  3. Known placental abnormality.\n  4. Known polyhydramnios or oligohydramnios\n  5. Known endocrine disorders, including untreated hyperthyroidism or untreated hypothyroidism, or uncontrolled diabetes mellitus at the time of consent.\n  6. Any signs of premature labour with the current pregnancy or having ongoing intervention (medical\u002F surgical) in the current pregnancy to prevent preterm birth.\n* At least THREE prior pregnancy complications or abnormalities at the time of consent, based on the investigator's judgment, that will increase the risk associated with the participation in and completion of the trial, including but not limited to the following:\n\n  1. Prior preterm delivery between 18 to ≤34 weeks gestation, or birth weight \\\u003C2200 grams; (may be based on maternal history of prior preterm delivery where these details are not otherwise documented)\n  2. Prior stillbirth or neonatal death within 7 days of birth.\n  3. Previous infant with a known genetic disorder or major congenital anomaly\n* Mother who is positive for syphilis and untreated at time of enrolment\n* Mother living with HIV\u002FAIDS considered to have WHO Clinical Stage 3 or 4 AIDS, or considered to be clinically unstable\n* Major illness of the maternal participant or conditions of the foetus that, in the investigator's judgment, will substantially increase the risk associated with the maternal participant's participation in, and completion of, the trial\n* Known or history of congenital or acquired immunodeficiency disorder, or rheumatologic disorder or other illness requiring chronic treatment with known immunosuppressant medications, including monoclonal antibodies, within the year prior to enrolment\n* Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behaviour or laboratory abnormality that may increase the risk associated with trial participation and, in the judgment of the investigator, would make the participant inappropriate for entry into this trial\n* Participation in other studies involving investigational drug(s) within 28 days prior to consent and\u002For during trial participation.\n* Use of systemic corticosteroids for \\>14 days within 28 days prior to trial enrolment. Prednisone use of \\\u003C20 mg\u002Fday for ≤14 days is permitted. Inhaled\u002Fnebulized, intra-articular, intra-bursal, or topical (skin or eyes) corticosteroids are permitted\n* Current alcohol abuse or illicit drug use\n* Receipt of blood or plasma products or immunoglobulin (Ig) in past 60 days or planned receipt through delivery, with exception of Rho(D) immune globulin (eg, RhoGAM), which can be given at any time\n* Previous vaccination with any licensed or investigational RSV vaccine or planned receipt during trial participation",true,"FEMALE","14 Years","55 Years",{"count":87,"type":22},13000,[89],"PHASE3","Respiratory syncytial virus (RSV) is a virus that often affects children during childhood. Even though most cases of RSV are mild, it can cause serious disease and even death - especially in very young babies, babies born too early and those born with heart and lung problems. It is the most common cause for children under 5 years old to be hospitalised. In 2019, there were about 33 million RSV-infections in the lower respiratory tract (in the lungs and below the voice box) of which 3,6 million people were hospitalised and 26,300 passed away in hospital due to RSV. Almost half (50%) of deaths that are caused by RSV, happen in children younger than 6 months old and the majority (more than 95%) of these deaths happen to infants and children in low- and middle-income countries.\n\nA way that can help protect babies from becoming infected is through giving vaccines against the germ (RSV) that is targeted for prevention. There are currently no registered vaccines that can be given directly to babies however there is a lot of information available that shows that a vaccine can be safely giving to a mother while she is still pregnant. The mother then produces antibodies (protection cells) that is transferred to the baby before the baby is born, and the baby is protected from getting sick during the first few months of life.\n\nOne of the vaccines that has been developed (ABRYSVO) has been used in many clinical trials in pregnant moms (and older people) to test if it is safe and will protect young babies and much older people who are all at the highest risk for a severe RSV disease. The vaccine was given to more than 4,000 pregnant women. The results from the study and previous studies showed that the vaccine was safe and the babies had a lower chance of getting severe RSV disease and going to hospital. It showed that the vaccine prevented severe RSV infection in around 80% of babies younger than 90 days, and 70% of babies younger than 6 months. Therefore, the vaccine has been licensed in a few countries around the world (including the United States of America and other high-income countries) which means that pregnant women can receive this vaccine during their pregnancy if they wish to (without being on a clinical trial). It has also been licensed in South Africa but is not yet available in the country for pregnant women to receive. The licensure is also underway in other African countries.\n\nHowever, the results of the previous studies of this vaccine also showed that a slightly higher number of premature babies were born to women who received the vaccine compared to women who did not receive the vaccine. The information received from these studies was however not enough to decide if the earlier births were related to the vaccine or not, and more information is needed - which is one of the main reasons for this study. Importantly, all of the babies who were born earlier were only born a few weeks earlier than expected (around 35 weeks of pregnancy), and all the babies were well and survived. The previous studies on this vaccine happened during the COVID-19 pandemic at which time people were wearing masks and contacting other people less therefore not spreading RSV around as we would normally expect. By doing this study, it will assist the investigators to determine if the vaccine is really as good as it is perceived to be for preventing serious RSV illness in the babies.\n\nThis RSV vaccine is a very important medical intervention, and it is as important that the effect that this vaccine will have on pregnant women and on the infants born to mothers who receive the vaccine can be measured. It is especially important in African and lower-middle income countries as the vaccine was not tested as much in people living in Africa compared to others. Therefore, the main reason for doing this trial is to see how much value the vaccine can bring to these countries in terms of protecting young babies and infants where many may get a severe infection and be hospitalised. It will also measure if the vaccine does increase the chances of a baby being born earlier than expected. It will only be carried out in the countries after the vaccine has been approved for use by pregnant women (at the right time) as part of their pregnancy care.",[92,93,94],"RSV Infections","RSV Immunisation","Preterm Labour","2026-05-14",{"date":97,"type":40},"2026-05-18",{"date":99,"type":40},"2025-09-03",{"date":101,"type":22},"2028-02-29",{"name":46,"class":47},11,""]