Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-25 @ 5:00 PM
Study NCT ID:
NCT02069834
Status:
WITHDRAWN
Last Update Posted:
2015-08-28
First Post:
2014-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dolutegravir + Rilpivirine Switch Study (DORISS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'One of the both Funder partners decided to stop the study before the initiation : thus no product provided and no funding to realize the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-27', 'studyFirstSubmitDate': '2014-02-18', 'studyFirstSubmitQcDate': '2014-02-20', 'lastUpdatePostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pilot phase: Percentage of patients with plasma viral load ≤ 50 copies HIV-RNA/ml from D0 (Day 0) to W16 (Week 16)', 'timeFrame': 'Week 16'}, {'measure': 'Non-inferiority phase: Percentage of patients with plasma HIV RNA maintained ≤ 50 copies/mL throughout 24 weeks', 'timeFrame': 'Week 24'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients with plasma viral load ≤50 HIV RNA copies/mL at Week 24 and Week 48', 'timeFrame': 'Week 48'}, {'measure': 'Percentage of patients with plasma viral load ≤50 HIV RNA copies/mL from Day 0 to Week 48', 'timeFrame': 'Week 48'}, {'measure': 'Percentage of virologic failure, defined as 2 consecutive plasma HIV RNA > 50 copies/mL', 'timeFrame': 'Week 48'}, {'measure': 'Measure of the profile of genotypic resistance in plasma in case of virologic failure', 'timeFrame': 'Week 48'}, {'measure': 'Percentage of patients who discontinued or changed the strategy of the study', 'timeFrame': 'Week 48'}, {'measure': 'Measure of the HIV-DNA between day 0 and week 48', 'timeFrame': 'W48', 'description': 'Evolution of the HIV-DNA between Day 0 and week 48'}, {'measure': 'Measure of CD4 lymphocytes at week 24 compared to day 0', 'timeFrame': 'Week 24', 'description': 'Evolution of CD4 lymphocytes (average) at Week 24 compared to Day 0'}, {'measure': 'Measure of CD4 lymphocytes at Week 48 compared to Day 0', 'timeFrame': 'Week 48', 'description': 'Evolution of CD4 lymphocytes (average) at Week 48 compared to Day0'}, {'measure': 'Number of patients with adverse events of grade 2 to 4', 'timeFrame': 'Week 48', 'description': 'Adverse events : incidence, grade and relation to study medication of all adverse events, of grade 2 to 4 events'}, {'measure': 'Measure of changes in serum plasma lipid parameters at week 24 compared to Day 0', 'timeFrame': 'Week 24', 'description': 'Mean changes in serum plasma lipid parameters at Week 24 compared to Day 0'}, {'measure': 'Measure of changes in serum lipid parameters at week 48 to Day 0', 'timeFrame': 'Week 48', 'description': 'Mean changes in serum plasma lipid parameters at Week 48 compared to Day 0'}, {'measure': 'Measure of changes in fat mass distribution at week 24 compared to Day 0', 'timeFrame': 'Week 24', 'description': 'Changes in fat mass distribution at Week 24 compared to Day 0'}, {'measure': 'Measure of changes in fat mass distribution at Week 48 compared to Day 0', 'timeFrame': 'Week 48', 'description': 'Changes in fat mass distribution at Week 48 compared to Day 0'}, {'measure': 'Measure of adherence to treatment at Week 24 compared to Day 0', 'timeFrame': 'Week 24', 'description': 'Evolution of adherence to treatment at Week 24 compared to Day 0 assessed by a validated questionnaire'}, {'measure': 'Measure of adherence to treatment at Week 48 compared to Day 0', 'timeFrame': 'Week 48', 'description': 'Evolution of adherence to treatment at Week 48 compared to Day 0 assessed by a validated questionnaire'}, {'measure': 'Measure of patient satisfaction for their treatment at Day 0', 'timeFrame': 'Day 0', 'description': 'Assessment of patient satisfaction for their treatment at D0 by questionnaire'}, {'measure': 'Measure of patient satisfaction for their treatment at Week 24', 'timeFrame': 'Week 24', 'description': 'Assessment of patient satisfaction for their treatment at Week 24 by questionnaire'}, {'measure': 'Measure of patient satisfaction for their treatment at Week 48', 'timeFrame': 'Week 48', 'description': 'Assessment of patient satisfaction for their treatment at Week 48 by questionnaire'}, {'measure': 'Measure of changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 24 compared to Day 0 .', 'timeFrame': 'Week 24', 'description': 'Changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 24 compared to Day 0 .'}, {'measure': 'Measure of changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 48 compared to Day 0 .', 'timeFrame': 'Week 48', 'description': 'Changes in plasma biomarkers of inflammation (hs-CRP and IL-6) and immune activation (sCD14 , MCP -1, IP10 ) at Week 48 compared to Day 0 .'}, {'measure': 'Measure of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 4', 'timeFrame': 'Week 4', 'description': 'Analysis PK (PharmacoKinetic) / PD (Pharmaodynamic) of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 4'}, {'measure': 'Measure of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 24', 'timeFrame': 'Week 24', 'description': 'Analysis PK / PD of plasma concentrations of Dolutegravir and Rilpivirine measured at Week 24'}, {'measure': 'Measure of the profile of genotypic resistance in plasma in case of virologic failure', 'timeFrame': 'Week 24'}, {'measure': 'Percentage of virologic failure, defined as 2 consecutive plasma HIV RNA > 50 copies/mL', 'timeFrame': 'Week 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Dolutegravir', 'Rilpivirine', 'PI- and NRTI- sparing ART regimen', 'switch study'], 'conditions': ['HIV Infection', 'HAART-treated', 'Virologically Controlled']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to evaluate the capacity of Dolutegravir + Rilpivirine vs. continued triple combination HAART to maintain plasma HIV RNA ≤ 50 copies/ml throughout 24 weeks in patients with plasma HIV RNA ≤ 50 copies/mL for at least 2 years under conventional HAART (2 NNRTI + 3rd agent).\n\nThe main secondary objectives are the following:\n\n* % of virologic success (plasma viral load ≤ 50 copies/mL) at W24 and W48\n* % of patients who maintain a plasma viral load ≤ 50 copies / ml from D0 to W48\n* % of virological failure defined by two consecutive plasma viral load \\> 50 copies/mL\n* Profile of genotypic resistance in case of virological failure.\n\nThe trial will be conducted according to the design below, in 3 steps:\n\n* Step 1: enrollment of 80 patients (40 in each arm)\n* Step 2: enrollment on hold until W16 data from the 40 patients enrolled in the intervention arm have been analyzed.\n* Step 3: resumption and completion of enrollment if conditions for resuming enrollment at the end of step 2 are fulfilled, i.e. if the percentage of patients randomized to the intervention arm who have a plasma viral load ≤ 50 copies/mL from D0 to W16 is significantly \\> 70%, which translates in a maximum of 6 virologic failures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* HIV-1 infection\n* Treatment with suppressive triple HAART (2 NRTI + either 1 PI/r, or 1 NNRTI, or INI), unchanged for \\> 6 months, Intra-class substitution within past 6 months is not considered as a treatment change.\n* Plasma HIV-RNA ≤ 50 copies/mL for \\> 2 years\n* CD4 cell count \\> 350/mm3 for \\> 6 months\n* No prior virologic failure under an NNRTI-containing or an INSTI-containing ART regimen\n* No NNRTI mutation on pre-ART genotype (if no pre-ART genotype available: no NNRTI mutation on DNA genotype at screening) among the following: K101E/P, E138A/G/K/Q/R/S, V179L, Y181C/I/V, Y188L, H221Y, M230I/L/V, L100I + K103N/S, L100I +K103R +V179D.\n* No mutation (either on pre-ART genotype or on DNA genotype at screening) among the following: T66K, G118R, V151L, S153F/Y, R263K, T66K + L74M, E92Q + N155H, Q148R +N155H, Q148H/K/R with at least one mutation of L74I or E138A/K/T or G140A/C/S\n* Negative HBs Ag\n* Informed consent form signed by patient and investigator\n* A specific consent for the pharmacokinetic substudy will be signed by the 10 patients of the pilot phase of the trial who will be randomized to the Dolutegravir + Rilpivirine arm and will volunteer for this PK study\n* Patient covered with health insurance\n* Effective contraception\n\nExclusion Criteria:\n\n* HIV-2 infection\n* Dialysis or severe renal failure (creatinine clearance \\< 30 ml/min)\n* History of decompensated liver disease\n* History of HIV-associated neurocognitive disorders\n* AST or ALT \\> 5 x ULN\n* Positive HBc Ac and negative HBs Ac\n* Patient receiving a proton pump inhibitor that cannot be switched to another anti-secretory drug\n* Current pregnancy or breastfeeding\n* Patient involved in another research that precludes enrolment in another trial\n* Patient under guardianship, or deprived of liberty by a court or administrative decision.'}, 'identificationModule': {'nctId': 'NCT02069834', 'acronym': 'DORISS', 'briefTitle': 'Dolutegravir + Rilpivirine Switch Study (DORISS)', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Dolutegravir + Rilpivirine Switch Study (DORISS): Pilot and Noninferiority Trial Comparing Dolutegravir + Rilpivirine vs. Continued HAART (Highly Active Antiretroviral Therapy) in Patients With Plasma HIV RNA ≤ 50 Copies/mL for at Least 2 Years', 'orgStudyIdInfo': {'id': 'RC13_0322'}, 'secondaryIdInfos': [{'id': '2013-003344-23', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 (intervention)', 'description': 'Dolutegravir 50 mg/d + Rilpivirine 25 mg/d qd orally (intake during a meal)', 'interventionNames': ['Drug: Arm 1 (intervention)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2 (control)', 'description': 'Continuation of existing HAART at the time of randomization', 'interventionNames': ['Drug: Arm 2 (control)']}], 'interventions': [{'name': 'Arm 1 (intervention)', 'type': 'DRUG', 'description': 'Dolutegravir 50 mg/j + Rilpivirine 25 mg/j qd orally (intake during meal)', 'armGroupLabels': ['Arm 1 (intervention)']}, {'name': 'Arm 2 (control)', 'type': 'DRUG', 'description': 'Continuation of existing HAART at the time of randomization', 'armGroupLabels': ['Arm 2 (control)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97159', 'city': 'Point-a-pitre', 'state': 'Guadeloupe', 'country': 'France', 'facility': 'CHU Guadeloupe'}, {'zip': '87261', 'city': 'Fort de France', 'state': 'Martinique', 'country': 'France', 'facility': 'CHU de Fort de France'}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Chu Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '93000', 'city': 'Bobigny', 'country': 'France', 'facility': 'Hôpital Avicenne', 'geoPoint': {'lat': 48.90982, 'lon': 2.45012}}, {'zip': '93140', 'city': 'Bondy', 'country': 'France', 'facility': 'Hôpital Jean Verdier', 'geoPoint': {'lat': 48.9018, 'lon': 2.48931}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de DIJON', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '85925', 'city': 'La Roche-sur-Yon', 'country': 'France', 'facility': 'CHD La Roche sur Yon', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'zip': '94275', 'city': 'Le Kremlin-Bicêtre', 'country': 'France', 'facility': 'CHU Kremlin Bicêtre', 'geoPoint': {'lat': 48.81471, 'lon': 2.36073}}, {'zip': '92300', 'city': 'Levallois-Perret', 'country': 'France', 'facility': 'Hôpital Perpetuel Secours', 'geoPoint': {'lat': 48.89389, 'lon': 2.28864}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75004', 'city': 'Paris', 'country': 'France', 'facility': 'CHU Hôtel Dieu Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75013', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital La Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker - enfants Malades', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75877', 'city': 'Paris', 'country': 'France', 'facility': 'CHU BICHAT - Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75908', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'CHU de Rennes - Hôpital Pontchaillou', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '93200', 'city': 'Saint-Denis', 'country': 'France', 'facility': 'CH Delafontaine', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}, {'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hôpital FOCH', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHRU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU de Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}