Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-04-16 @ 1:04 AM
Study NCT ID:
NCT02976259
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C562325', 'term': 'dolutegravir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-28', 'studyFirstSubmitDate': '2016-11-22', 'studyFirstSubmitQcDate': '2016-11-24', 'lastUpdatePostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal fluid', 'timeFrame': '2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks', 'description': 'Measure of HIV-RNA level in blood plasma and seminal fluid at each point and comparaison about the decay between both'}], 'secondaryOutcomes': [{'measure': 'The evolution of HIV proviral DNA in the peripheral blood mononuclear cells (PBMC) and in seminal fluid', 'timeFrame': 'Day 0 and 48 weeks'}, {'measure': 'Comparison of dolutegravir concentration in blood plasma and seminal fluid', 'timeFrame': '2 weeks, 4 weeks, 8 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks', 'description': 'Measure of doltegravir concentration in blood and seminal fluid at each points and comparaison of the value between the 2 compartments'}, {'measure': 'Analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved', 'timeFrame': 'Day 0 and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['HIV Infection Primary']}, 'descriptionModule': {'briefSummary': 'Sponsor: IMEA - Fondation Internationale Léon Mba C.H.U. Bichat - Claude Bernard 46, Rue Henri Huchard - 75018 PARIS Tél. : 01.40. 25. 63. 65 - Fax : 01.40.25.63.56\n\nCoordinating investigator:\n\nDr Caroline Lascoux Combe Hôpital Saint Louis Service Maladies Infectieuses\n\n1 avenue Claude Vellefaux - 75010 PARIS Tél. : 01 42 49 49 73 - Fax : 01 42 49 47 43 E-mail : caroline.lascoux-combe@aphp.fr\n\nParticipating country : FRANCE\n\nPrimary objective : Comparing the kinetic of HIV-RNA decay in blood plasma and in seminal plasma in patients starting a triple combination regimen with dolutegravir + tenofovir DF (TDF) + emtricitabine (FTC) at the time of PHI.\n\nSecondary objectives :\n\n* Comparison of HIV-1 RNA level in plasma (threshold 20 and 1 copies/ml) and in seminal plasma (threshold 60 copies/ml) at each visit D0, W2, W4, W8, W12, W24, W36, W48\n* To assess the frequency of intermittent shedding in seminal plasma once virological suppression has been achieved and until W48\n* Evolution of cellular HIV-1 DNA level in PBMC and in non-sperm cells between D0 and W48\n* Comparison of dolutegravir concentration in blood plasma and seminal plasma\n* Study of risk factors associated with viral persistence of HIV-RNA in the seminal plasma\n* Analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved (i.e. at D0 and W12)\n\nInclusion criteria :\n\n* Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii) a western blot profile compatible with ongoing seroconversion (incomplete western blot with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative test for HIV antibodies followed within 3 months by a positive HIV serology\n* Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245 mg/200 mg) initiated by the referee physician within a maximum of 15 days after diagnosis of PHI\n* Genotypic sensitivity to TDF, FTC and DTG\n* Patient with medical care insurance\n\nExclusion criteria :\n\n* Chronic infection\n* Infection or co-infection with HIV-2\n\nStudy treatment : Dolutegravir and tenofovir/emtricitabine Number of subjets : 20 patients (exploratory study)', 'detailedDescription': 'Secondary objectives :\n\n* Comparison of HIV-1 RNA level in plasma (threshold 20 and 1 copies/ml) and in seminal plasma (threshold 60 copies/ml) at each visit D0, W2, W4, W8, W12, W24, W36, W48\n* To assess the frequency of intermittent shedding in seminal plasma once virological suppression has been achieved and until W48\n* Evolution of cellular HIV-1 DNA level in PBMC and in non-sperm cells between D0 and W48\n* Comparison of dolutegravir concentration in blood plasma and seminal plasma\n* Study of risk factors associated with viral persistence of HIV-RNA in the seminal plasma\n* Analysis by deep sequencing of the viral population (quasi-species) in both compartments (blood plasma and seminal plasma) before virological suppression has been achieved (i.e. at D0 and W12)\n\nInclusion criteria :\n\n* Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii) a western blot profile compatible with ongoing seroconversion (incomplete western blot with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative test for HIV antibodies followed within 3 months by a positive HIV serology\n* Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245 mg/200 mg) initiated by the referee physician within a maximum of 15 days after diagnosis of PHI\n* Genotypic sensitivity to TDF, FTC and DTG\n* Patient with medical care insurance\n\nExclusion criteria :\n\n* Chronic infection\n* Infection or co-infection with HIV-2\n\nStudy treatment : Dolutegravir and tenofovir/emtricitabine Number of subjets : 20 patients (exploratory study)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed at the time of primary HIV infection (PHI) (i) a negative or indeterminate HIV ELISA associated with a positive antigenemia or plasma HIV RNA, (ii) a western blot profile compatible with ongoing seroconversion (incomplete western blot with absence of antibodies to pol proteins (p34, p68)) or (iii) an initially negative test for HIV antibodies followed within 3 months by a positive HIV serology\n* Treatment including dolutegravir (DTG 50mg) + tenofovir/emtricitabine (TDF/FTC 245 mg/200 mg) initiated by the referee physician within a maximum of 15 days after diagnosis of PHI\n* Genotypic sensitivity to TDF, FTC and DTG\n* Patient with medical care insurance\n\nExclusion Criteria:\n\n* Chronic infection\n* Infection or co-infection with HIV-2'}, 'identificationModule': {'nctId': 'NCT02976259', 'acronym': 'DOLUPRIM', 'briefTitle': 'Kinetics of HIV-RNA Decay in Seminal Plasma of Men Treated by Dolutegravir at the Time of Primary HIV Infection', 'organization': {'class': 'OTHER', 'fullName': "Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba"}, 'officialTitle': 'Kinetics of HIV-RNA Decay in Seminal Plasma of Men Receiving a Dolutegravir-based Regimen at the Time of Primary HIV Infection (IMEA 051-DOLUPRIM Study)', 'orgStudyIdInfo': {'id': 'IMEA 051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient HIV primary infection', 'description': 'HIV primary infection Patient male receiving Dolutegravir', 'interventionNames': ['Drug: Dolutegravir']}], 'interventions': [{'name': 'Dolutegravir', 'type': 'DRUG', 'description': 'All patients included must have treated by dolutegravir. They will have some exams (plasma samples, sperm samples)', 'armGroupLabels': ['Patient HIV primary infection']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}