[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":128},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,66,88,109],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100575637","phase-2-doravirinelamivudine-dor3tc-as-a-maintenance-art-in-comparison-with-dolutegravirlamivudine-dtg3tc-in-plwh-successfully-100575637",false,"NCT06774872","Doravirine\u002FLamivudine (DOR\u002F3TC) as a Maintenance ART in Comparison With Dolutegravir\u002FLamivudine (DTG\u002F3TC) in PLWH Successfully","MODULO Trial: Doravirine\u002FLamivudine (DOR\u002F3TC) as a Maintenance ART in Comparison With Dolutegravir\u002FLamivudine (DTG\u002F3TC) in PLWH Successfully Treated With Three-drug Regimens at Inclusion","MODULO","Inclusion Criteria:\n\n* Adults ≥18 years;\n* Living with HIV-1;\n* With pVL \\\u003C50 copies\u002FmL for at least 24 months;\n* Under stable three-drug regimen including 2 NRTIs + 1 NNRTI or 1 INSTI or 1 boosted PI for at least 12 months;\n* Affiliated to the French Social Insurance;\n* Who have given their written consent to participate in the study\n\nExclusion Criteria:\n\n* HIV-2 co-infection;\n* Co-infection with hepatitis B virus (positive HBsAg and\u002For positive anti-HBc antibody with negative anti-HBs antibody);\n* Documented resistance mutation or association of resistance mutations, associated with partial or full resistance to doravirine, dolutegravir or lamivudine;\n* At least one resistance genotype is mandatory to include the patient:\n\n  * If there was no virological failure under NRTI, NNRTI and INSTI in the past:\n\n    * Pretherapeutic HIV-RNA genotype,\n    * OR, in case of no available HIV-RNA genotype, genotype on proviral HIV-DNA to performed before inclusion,\n  * In case of virological failure under NRTI, NNRTI and INSTI in the past:\n\n    * HIV-RNA genotype at time of virological failure,\n    * OR, in case of no available HIV-RNA genotype at time of failure, genotype on proviral HIV-DNA to performed before inclusion to be sure that the virus is fully sensitive to the study treatments,\n  * Past virological failure is defined as: 2 consecutive pVL ≥50 copies\u002FmL or one pVL ≥200 copies\u002FmL,\n  * Resistance genotypes will be interpretated with the last available ANRS algorithm.\n* Glomerular filtration rate \\\u003C50 mL\u002Fmin (CKD-EPI formula);\n* Comedications leading to drug-drug interaction with one of the 3 study drugs (cf. detailed protocol);\n* Pregnant or breastfeeding women, and women with age to be pregnant but refusing effective contraception, whether or not a desire for pregnancy is expressed;\n* Any clinal condition limiting the participation in a clinical trial: Immunocompromised conditions including active cancer or hematological malignancy, organ transplant or with transplant rejection within the last 6 months, immunosuppressive therapy, or other condition that in the opinion of the investigator could cause impaired host immunity\n* Protected adults (persons under legal guardianship or under \"sauvegarde de justice\" (judicial protection due to temporarily and slightly diminished mental or physical faculties)","ALL","18 Years",{"count":20,"type":21},408,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The main objective of the MODULO trial is to compare (non-inferiority) the capacity of DOR\u002F3TC and DTG\u002F3TC two-drug regimens of maintain virological success at W48 in people living with HIV virus ( PLWH) with suppressed HIV plasma viral load (pVL) under three-drug regimen at inclusion.\n\nThe virological success is defined as no virological failure (2 consecutive pVL ≥50 copies\u002FmL or one pVL ≥50 copies\u002FmL followed with discontinuation of treatment or follow-up).",[27],"HIV-1-infection","RECRUITING","2025-06-06",{"date":31,"type":32},"2025-06-11","ACTUAL",{"date":34,"type":32},"2025-04-30",{"date":36,"type":21},"2028-06-15",{"name":38,"class":39},"Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":64,"locationsCount":65},"100592708","evaluation-of-the-acceptability-and-impact-of-a-sexual-health-screening-and-prevention-program-for-vulnerable-women-100592708","NCT06996938","Evaluation of the Acceptability and Impact of a Sexual Health Screening and Prevention Program for Vulnerable Women","PrEVE: Evaluation of the Acceptability and Impact of a Sexual Health Screening and Prevention Program for Vulnerable Women in the Greater Paris Region","PrEVE","Inclusion Criteria:\n\n* Female, 18 years of age or older\n* Living in Ile de France\n* In a vulnerable situation with at least one of the following two situations:\n\n  * Social\u002Feconomic vulnerability (without personal residence or residence permit of less than 2 years or expiring in less than 1 year or without social security\u002FAME\u002FPUMA (ex CMU)\n  * Sexual vulnerability: occasional paid sex worker\n* Able to understand the objectives of the study\n* Having been informed of the study objectives and not opposed to participating in the study.\n* Having signed the consent form prior to any examination being performed in the study.\n\nExclusion Criteria:\n\n• Person protected by law, or not in a position to express their consent or subject to a measure of guardianship or safeguard of justice",true,"FEMALE",{"count":52,"type":21},200,[54],"NA","Globally, women accounted for more than half of people living with HIV (53%) in 2022. In France, 54% of new infections were heterosexual in 2022, 71% of whom were born abroad, mainly in sub-Saharan Africa (74%). Among women, 80% of new cases were born abroad, of which at least 30% contracted HIV after arriving in France, often in connection with social vulnerability as shown by the French study Parcours. In the Paris region, 1,243 new cases among women were registered between 2018 and 2021 (about 300 per year).\n\nUnstable housing, experiences of violence, lack of residence permits and sex trade increase the risk of HIV among women. Positive test migrants often report a higher frequency of forced sex. These women also face high risks of other STIs, unwanted pregnancies, violence and mental health problems.\n\nPrEP is a means of preventing HIV infection by taking an antiretroviral drug, which has been fully proven to be effective in the form of tablets or injections. Pre-Exposure Prophylaxis (PrEP) is part of a comprehensive prevention service pathway.\n\nDespite the free availability of PrEP in France from 2027 and essential monitoring tools for men and women at high risk, women at risk remain largely uncovered by prevention initiatives, making them a \"hidden population\" under-studied. In France, recent data show that only 5% of PrEP users are women, compared to 95% of men, mainly men who have sex with men (MSM).\n\nSeveral factors hinder access to PrEP, including limited knowledge of available services, misperceptions of risk (because women rarely initiate sexual intercourse), fear of stigma and lack of resources. In addition, France lacks comprehensive programs that integrate health care, sexual health, mental health and social and legal support for these women.\n\nThe PrEVE study aims to demonstrate that the involvement of community-based organizations can play an important role in engaging and retaining women in vulnerable situations in a sexual health program. This program provides information, screening and prophylaxis to meet the specific sexual health needs of vulnerable women.",[57],"Vulnerable Population","2025-05-21",{"date":60,"type":32},"2025-05-30",{"date":62,"type":32},"2025-03-21",{"date":36,"type":21},{"name":38,"class":39},2,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":74,"targetDuration":76,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":40},"100577518","real-world-use-of-lenacapavir-as-an-add-on-to-an-optimized-background-regimen-in-france-100577518","NCT06799338","Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France","Real World Use of Lenacapavir, as an add-on to an Optimized Background Regimen in France: a Retrospective Observational Study (LENAddOn)","LENAddON","Inclusion Criteria:\n\n* Adults (≥18 years);\n* With HIV-1 infection;\n* Who received a first dose of LEN (oral or injectable) with and OBR from the ending of the French national early access program (20 June 2023) to 30 June 2024;\n* Who did not refuse the collection and use of their data.\n\nExclusion Criteria:\n\n\\- HIV-2 infection.",{"count":75,"type":21},80,"52 Weeks","OBSERVATIONAL","For most people with HIV (PWH), an effective antiretroviral regimen can be devised. However, some PWH have multiple treatment failures due to viral resistance or unacceptable side effects to medication and no longer have durable viral suppression. People with multidrug-resistant HIV-1 are at increased risk for hospitalization, progression to acquired immunodeficiency syndrome, and death.\n\nLenacapavir (LEN) is a first-in-class capsid inhibitor and has been evaluated through the CAPELLA phase 3 trial in PWH with replicative multidrug-resistant HIV-1. In this trial, LEN combined with an optimized background regimen (OBR) led to high levels of viral suppression, as more than 80% of participants achieved undetectable plasma HIV-RNA, associated with increasing in CD4 T cell counts.\n\nLEN has become publicly available in France from June 20, 2023, and prescriptions are discussed and validated by multidisciplinary committees in the hospitals, including HIV physicians, virologists and pharmacologists.\n\nFrom the time LEN was made publicly available in France, no real-world data have been generated to describe the real-world use of LEN, in association with an OBR, in various patient's profiles who may differ from the subjects included the CAPELLA trial.\n\nThus, investigators plan to conduct a national, multicenter, retrospective observational study to describe baseline socio-demographic, clinical and biological profiles of PWH receiving LEN + OBR in French real-world settings, to determine the continuation of LEN injections at weeks 26 and 52, and to determine the reasons for stopping LEN in case of no continuation of LEN injections.\n\nIn its current indication, LEN is reserved for a minority of PWH. However, France is the second-largest prescribing country for this drug, and one year after it was first marketed, it seems essential to review its use. Whether LEN injections are continued 6 and 12 months after starting treatment is a crucial question for understanding its use in treatment centers.\n\nLenacapavir has become publicly available in France in June 20, 2023. LEN prescriptions in France are discussed and validated by multidisciplinary committees, including HIV physicians, virologists and pharmacologists in the hospitals.",[80],"HIV I Infection",{"date":82,"type":32},"2025-05-22",{"date":84,"type":32},"2025-03-03",{"date":86,"type":21},"2025-12-31",{"name":38,"class":39},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":49,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":40},"100535922","evolution-of-the-clinical-immuno-virological-and-aging-trajectory-of-patients-living-with-hiv-100535922","NCT06258122","Evolution of the Clinical, Immuno-virological and Aging Trajectory of Patients Living With HIV","Evolution Over 15 Years (2008-2023) of the Clinical, Immuno-virological and Aging Trajectory of Patients Living With HIV","TEMPO2","Inclusion Criteria:\n\n* Previous participation to the TEMPO-1 study\n* 18 years of age or older\n* HIV-infected individuals and non-HIV infected control group\n* Be affiliated or beneficiary of a social security scheme\n* Have signed the consent form.\n\nExclusion Criteria:\n\n* Subject under \" sauvegarde de justice \" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship",{"count":97,"type":21},120,"Main objective is:\n\n* To characterize the evolution of the immuno-virological profile of circulating blood cells and immune aging in patients who had participated to TEMPO-1 in 2007-2008\n* To evaluate the role of immune aging and inflammatory profile in the occurrence of comorbidities in HIV-infected individuals over a 15-year period\n\nThe alterations that affect the innate and adaptive immune cell compartments in HIV-infected patients are reminiscent of the process of immune aging, characteristic of old age. These alterations, the presumed cause of which is the chronic systemic immune activation established in patients, contribute to the depletion of lymphoid resources which probably leads to the decline of immune competence with the progression of HIV disease.\n\nThe comparison between HIV-1-infected patients and uninfected older adults goes beyond the mere appearance of immunosenescence and extends to the deterioration of a number of physiological functions linked to inflammation and to systemic aging.\n\nBy inducing persistent and lasting immune activation, HIV-1 infection is now considered a model of accelerated immunosenescence and systemic aging. During this process, the immune system quickly becomes exhausted, because the source of its exhaustion (i.e. HIV) cannot be eliminated.\n\nTo determine which factors may contribute to immunosenescence in HIV-1 infection, we propose an extensive immune and virological evaluation in patients who participated in a cross-sectional assessment of immune functions and TEMPO-1 viral reservoirs after 15 years of evolution in order to determine their immune and viral trajectories, to compare these trajectories with the major clinical events and the comorbidities occurring in them.",[100],"HIV Infections","2025-01-09",{"date":103,"type":32},"2025-01-10",{"date":105,"type":32},"2024-04-23",{"date":107,"type":21},"2025-12-15",{"name":38,"class":39},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":40},"100401928","phase-2-hiv-1-infected-patients-phase-ii-trial-dual-combination-doravirineraltegravir-open-label-100401928","NCT04513626","HIV-1 Infected Patients, Phase II Trial, Dual Combination Doravirine\u002FRaltegravir Open Label","A Randomized Comparative Phase II Trial Evaluating the Capacity of the Dual Combination Doravirine\u002FRaltegravir to Maintain Virological Success in HIV-1 Infected Patients With an HIV-RNA Plasma Viremia Below 50 Copies\u002FmL Under a Current Antiretroviral Regimen","DORAL","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients with HIV-1 documented infection\n* CD4 ≥ 200\u002Fmm3\n* On stable combined ART regimen with at least 2 drugs for at least 6 months\n* HIV-RNA plasma VL ≤ 50 copies\u002FmL during the last 12 months prior to screening visit (W-6\u002FW-4), documented by at least 2 time-points with no more than one blip (defined as one HIV-RNA plasma VL between 51 and 200 copies\u002FmL followed by one HIV-RNA plasma VL ≤ 50 copies\u002FmL)\n* Naive to doravirine\n* Absence of resistance to doravirine\\* and\u002For raltegravir\\*\\*(see list mutations below)\n\n  * on all HIV-genotypes with available RT and integrase gene sequences allowing resistance interpretation in case of previous virological failure\n  * or on DNA genotype performed at screening if HIV genotype is not available in case of prior virological failure.\n* Signed informed consent form.\n* Patient affiliated to a social insurance regimen. For French patients only: subject enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme).\n\n  * Mutations associated to doravirine resistance are: V106A\u002FM, Y188L, G190E\u002FS, M230L, F227C, at least 2 among: A98G, L100I, K101E, V106I, E138K, Y181C\u002FV, G190A or H221Y\n\n    * Mutations associated to raltegravir resistance are: T66A\u002FK, E92Q, G118R, F121Y, G140A\u002FS Y143A\u002FC\u002FG\u002FH\u002FR\u002FS, Q148E\u002FG\u002FH\u002FK\u002FR, V151L, N155H\u002FS\u002FT, E157Q, S230R, R263K, L74 F\u002FI + V75I.\n\nExclusion Criteria:\n\n* Absence of RT and INI HIV sequence available (past genotypes or failure of amplification of DNA at screening)\n* HBV co-infection\n* Hemoglobin \\\u003C9 g\u002FdL\n* Platelets \\\u003C80,000\u002Fmm3\n* Creatinine clearance \\\u003C60 mL\u002Fmin (MDRD)\n* AST or ALT ≥5N\n* Concomitant DAA for anti-HCV therapy\n* Any severe concomitant illness\n* Any drug with potential drug-drug interaction with doravirine\n* Concomitant treatment using interferon, interleukins or any other immune-therapy or chemotherapy\n* Concomitant prophylactic or curative treatment for an opportunistic infection\n* All conditions (use of alcohol, drugs, etc.) judged by the investigator to possibly interfere with trial protocol compliance, adherence and\u002For trial treatment tolerance\n* Subjects under \"sauvegarde de justice\" (judicial protection due to temporarily and slightly diminished mental or physical faculties), or under legal guardianship\n* Subjects participating in another clinical trial evaluating different therapies and including an exclusion period that is still in force during the screening phase\n* Pregnant women or breastfeeding women",{"count":118,"type":21},150,[24],"The objective of antiretroviral therapy (ART) is the maintenance of HIV viral suppression, the optimal condition to prevent disease progression, to optimize immune restoration, to prevent the development of viral resistance and to reduce viral transmission. Antiretroviral therapy has to be maintained long life over decades in the absence of strategies for HIV cure. This is why the long-term cumulative toxicity of ARV drugs is a major issue. Indeed as a consequence of potent ART strategies, in 2011 over 88% of patients on ART in the French Hospital database (ANRS CO4 FHDH) achieved viral suppression with HIV-RNA plasma viral load \\\u003C 50 copies\u002FmL and nearly 60% had CD4 \\> 500\u002Fmm3. As a consequence of massive reduction of mortality and morbidity related to HIV, infected patients are aging with 40% of patients over 50 years of age in the ANRS CO4 FHDH.\n\nThe current standard-of-care for antiretroviral therapy consists in a triple drug combination with two nucleoside reverse transcriptase inhibitors (NRTIs) plus either a non-nucleoside reverse transcriptase inhibitor (NNRTI), a protease inhibitor (PI), or an integrase inhibitor (INSTI). NRTIs and PIs have been associated to cumulative long-term toxicity such as bone and renal disorders related to tenofovir and increased cardio-vascular risk with PIs. In general population, aging is associated with well-known comorbidities such as bone demineralization, increased incidence of cardio or cerebrovascular disease, diabetes, renal dysfunction. HIV infected patients are at a greater risk for such abnormalities. Another crucial concern is the high probability of drug-drug interactions in HIV-infected patients, between ART and comedications.\n\nAlternative strategies are needed, which must address the following questions: how to maintain the control of HIV viral replication while minimizing the occurrence of long-term clinical and metabolic complications, and minimizing the risk of drug-drug interactions?\n\nThis study is an open label, randomized, switch study over 96 weeks in which virally suppressed patients on a stable combined ART regimen will be randomized (2:1) to an immediate switch to doravirine\u002Fraltegravir (immediate switch group) or to the maintaining of their current ART followed by a switch to doravirine\u002Fraltegravir at W48 (delayed switch group). Patients will be followed during 96 weeks.",[100],{"date":103,"type":32},{"date":124,"type":32},"2020-09-15",{"date":126,"type":21},"2025-10-30",{"name":38,"class":39},""]