Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-03-01 @ 6:28 AM
Study NCT ID:
NCT03836833
Status:
UNKNOWN
Last Update Posted:
2019-06-07
First Post:
2018-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2022-03-23', 'releaseDate': '2022-01-21'}], 'estimatedResultsFirstSubmitDate': '2022-01-21'}}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-06-05', 'studyFirstSubmitDate': '2018-12-13', 'studyFirstSubmitQcDate': '2019-02-08', 'lastUpdatePostDateStruct': {'date': '2019-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation', 'timeFrame': '0-12 hours', 'description': '0 -12 hours Area under the curve plasma concentration versus time for LPV, ABC and 3TC in the 4-in- formulation'}], 'secondaryOutcomes': [{'measure': 'Plasma concentration at 12 hours for LPV in the 4in1 formulation', 'timeFrame': '12 hours', 'description': 'Plasma concentration at 12 hours for LPV in the 4in1 formulation'}, {'measure': 'Peak plasma concentration (Cmax) of LPV, ABC and 3TC with the 4-in-1 formulation.', 'timeFrame': '3-5 weeks', 'description': 'Plasma concentration maximum of LPV, ABC and 3TC with the 4-in-1 formulation.'}, {'measure': 'Concentration time maximum for LPV, ABC and 3TC with the 4-in-1 formulation.', 'timeFrame': '3-5 weeks', 'description': 'Concentration time maximum for LPV, ABC and 3TC with the 4-in-1 formulation.'}, {'measure': 'Clearance function for LPV, ABC and 3TC with the 4-in-1 formulation.', 'timeFrame': '3-5 weeks', 'description': 'Clearance function for LPV, ABC and 3TC with the 4-in-1 formulation.'}, {'measure': 'Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen', 'timeFrame': '0 - 12 hours', 'description': 'Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.'}, {'measure': 'Area under curve plasma concentration versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.', 'timeFrame': '0 - 12 hours', 'description': 'Area under curve plasma concentration versus time (0-12) in the 4-in-1 formulation versus the reference treatment regimen.'}, {'measure': 'Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC in the 4-in-1 formulation versus the reference treatment regimen.', 'timeFrame': '0 - 12 hours', 'description': 'Geometric mean ratio (GMR) of steady state LPV, ABC and 3TC in the 4-in-1 formulation versus the reference treatment regimen.'}, {'measure': 'Peak plasma concentration in the 4-in-1 formulation versus the reference treatment regimen.', 'timeFrame': '3-5 weeks', 'description': 'Peak plasma concentration in the 4-in-1 formulation versus the reference treatment regimen.'}, {'measure': 'Safety: A description of the proportion of children experiencing an Adverse event or Serious Adverse event binomial distribution compared between the two formulations.', 'timeFrame': '6-8 weeks', 'description': 'Safety: A description of the proportion of children experiencing an Adverse event or Serious Adverse event binomial distribution compared between the two formulations.'}, {'measure': 'Safety: Summary of the number and percent of subjects with documented Grade 3 or higher adverse events; each summary will be conducted overall and by formulation', 'timeFrame': '6-8 weeks', 'description': 'Safety: Summary of the number and percent of subjects with documented Grade 3 or higher adverse events; each summary will be conducted overall and by formulation'}, {'measure': 'Proportion of children with viral load <1000 copies/ml', 'timeFrame': '6-8 weeks', 'description': 'Comparison of proportion of children with viral load less than 1000 copies/ml at baseline and at end of the study.'}, {'measure': 'Changes in CD4 counts compared to baseline', 'timeFrame': '6-8 week', 'description': 'Changes in CD4 counts compared to baseline'}, {'measure': 'Changes in CD4 percentage compared to baseline', 'timeFrame': '6-8 weeks', 'description': 'Changes in CD4 percentage compared to baseline'}, {'measure': 'Acceptability: Description of factors that affect acceptability of the 4 in1 formulation', 'timeFrame': '6-8 weeks', 'description': 'Description of factors that affect acceptability of the 4in1 formulation as reported by the caregivers'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV']}, 'referencesModule': {'references': [{'pmid': '36968554', 'type': 'DERIVED', 'citation': "Rotsaert A, Ogara C, Mwanga-Amumpaire J, Kekitiinwa AR, Musiime V, Najjingo E, Kisitu GP, Nazzinda R, Nambi E, Lee J, Diallo M, Kyomuhendo F, Waweru M, Andrieux-Meyer I, Nostlinger C. Acceptability of a new 4-in-1 Abacavir/Lamivudine/Lopinavir/Ritonavir paediatric fixed-dose combination: the caregiver-child dyads' perspective. Ther Adv Infect Dis. 2023 Mar 21;10:20499361231159993. doi: 10.1177/20499361231159993. eCollection 2023 Jan-Dec."}]}, 'descriptionModule': {'briefSummary': 'A phase I/II, open label, randomized crossover pharmacokinetic, safety and acceptability study of the Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination vs. Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg tablets) in HIV infected Children.\n\nThe study is intended to support the adoption of the 4-in-1 by healthcare providers and will provide data that may support its registration in certain countries. The study will be carried out in HIV-infected children in Uganda weighing 3 to 25 kg (inclusive) and unable to swallow tablets and will provide supportive clinical data on the pharmacokinetics, safety, tolerability and acceptability of the 4-in-1.', 'detailedDescription': 'The primary objective is to estimate the population average exposure to LPV, ABC and 3TC provided by the 4-in-1 formulation in HIV-infected children dosed per WHO weight bands.\n\nThe secondary objectives:\n\n* To determine the proportion of children overall, and within each weight band, with a lopinavir C12 \\<1.0 mg/L while receiving the 4-in-1 formulation\n* To evaluate and compare the safety and tolerability of the 4-in-1 formulation versus a reference treatment regimen.\n* To compare the bioavailability of LPV, ABC and 3TC in the 4-in-1 formulation versus a reference treatment regimen.\n* To assess post exposure CD4 and viral load\n* To assess the factors that contribute to acceptability of the new 4-in-1 formulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Children \\> 4 weeks old and weighing ≥3 and \\<25 kg at the time of enrolment\n* Past or current documentation of a confirmed diagnosis of HIV infection defined as two positive assays from two different samples. The two results may be in any combination of the following:\n* At any age: HIV-1 DNA PCR positive\n* Documented past HIV-1 RNA viral load \\> 1,000 copies/mL plasma\n* At any age \\>18 months of age: HIV-1 antibody reactive on two different rapid tests based on national testing algorithm\n* ARV treatment eligible children with LPV-based treatment indication\\* as defined by country-specific guidelines or the WHO paediatric treatment guidelines and confirmed by the investigator\n* HIV RNA viral load \\<1000 copies/mL (suppressed) at the screening visit\\*\n* Inability to swallow LPV/r tablets\n* Parent or guardian able and willing to provide written informed consent.\n* For lowest weight band (≥3 and ≤ 5.9kgs) ONLY: under treatment for at least 3 weeks but not more than 12 weeks.\n\n * Does not apply to the youngest children (≥3 and ≤ 5.9kgs)\n\nExclusion Criteria:\n\n* Planned or concurrent use of NNRTIs, integrase inhibitors, entry inhibitors, or Protease Inhibitors (PIs) other than LPV/r.\n* Treatment failure with proven resistances to PIs.\n* Contraindication to use of PIs\n* Clinical condition requiring the use of a prohibited medication (see section 7.6) in association with LPV/r, ABC/3TC (Refer to section 7.2- 7.3 of the IB)\n* Pulmonary Tuberculosis and any clinically significant disease or finding during screening that, in the investigator's opinion, would compromise participation in this study.\n* Treatment with experimental drugs (except for LPV/r Pellets) for any indication within 30 days prior to study entry\n* Anticipated transfer of care to a non-participating health facility during the study period"}, 'identificationModule': {'nctId': 'NCT03836833', 'acronym': 'LOLIPOP', 'briefTitle': 'Lopinavir/r/ Lamivudine/ Abacavir as an Easy to Use Paediatric Formulation', 'organization': {'class': 'OTHER', 'fullName': 'Drugs for Neglected Diseases'}, 'officialTitle': 'Pharmacokinetic, Safety and Acceptability Study of the Abacavir/Lamivudine/Lopinavir/Ritonavir/-30/15/ 40/10mg vs. Lopinavir/Ritonavir 40/10mg Pellets Plus Dual Abacavir/Lamivudine-60/30mg Tablets in HIV Infected Children', 'orgStudyIdInfo': {'id': 'DNDi-4in1-01-PHIV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '4in1 granules', 'description': 'Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination in granules formulation administered twice daily for at least 3 weeks, Followed by Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) administered twice daily for at least 3 weeks.', 'interventionNames': ['Drug: ABC/3TC/LPV/r granules (30/15/40/10 mgs)', 'Drug: LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)']}, {'type': 'EXPERIMENTAL', 'label': 'LPV/r Pellets Plus ABC/3TC', 'description': 'Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets) administered twice daily for at least 3 weeks.\n\nFollowed by Abacavir/Lamivudine/ Lopinavir/Ritonavir (30/15/ 40/10mg ;4-in-1) Fixed-Dose Combination in granules formulation administered twice daily for at least 3 weeks', 'interventionNames': ['Drug: ABC/3TC/LPV/r granules (30/15/40/10 mgs)', 'Drug: LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)']}], 'interventions': [{'name': 'ABC/3TC/LPV/r granules (30/15/40/10 mgs)', 'type': 'DRUG', 'otherNames': ['4in1 Granules'], 'description': "This is a fixed dose combination. Each capsule contains Lopinavir (40mg), Ritonavir (10mg), Abacavir (30mg) and Lamivudine (15mg) in granules formulation.\n\nDosage according to patient's weight:\n\nBetween 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day", 'armGroupLabels': ['4in1 granules', 'LPV/r Pellets Plus ABC/3TC']}, {'name': 'LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)', 'type': 'DRUG', 'otherNames': ['L PV/r Pellets Plus ABC/3TC tablets'], 'description': "Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets)\n\nDosage according to patient's weight:\n\nLPV/r Pellets:\n\nBetween 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day\n\nABC/3TC:\n\nBetween 3 and 5.9kg: 1 tablet twice a day Between 6 and 9.9kg: 1.5 tablets twice a day Between 10 and 13.9kg: 2 tablets twice a day Between 14 and 19.9kg: 2.5 tablets twice a day Between 20 and 24.9kg: 3 tablets twice a day", 'armGroupLabels': ['4in1 granules', 'LPV/r Pellets Plus ABC/3TC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Prof. Adeodata Kekitiinwa, MBChM, MMeD', 'role': 'CONTACT', 'email': 'akekitiinwa@baylor-uganda.org', 'phone': '+256772462686'}], 'facility': "Baylor College of Medicine Children's Foundation Uganda", 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Kampala', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Victor Musiime, MBChB,PhD', 'role': 'CONTACT', 'email': 'vmusiime@jcrc.org.ug', 'phone': '+256 417 723000'}], 'facility': 'Joint Clinical research Centre', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Mbarara', 'status': 'RECRUITING', 'country': 'Uganda', 'contacts': [{'name': 'Prof. Juliet Mwanga, MBChB, MMED', 'role': 'CONTACT', 'email': 'juliet.mwanga@epicentre.msf.org', 'phone': '+256 793328748'}], 'facility': 'Epicentre Mbarara Research Centre', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}], 'centralContacts': [{'name': 'Isabelle Andrieux-Meyer, MD', 'role': 'CONTACT', 'email': 'iandrieux-meyer@dndi.org', 'phone': '+41 22 906 92 68'}], 'overallOfficials': [{'name': 'Isabelle Andrieux-Meyer, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Drugs for Neglected Diseases initiative'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Drugs for Neglected Diseases', 'class': 'OTHER'}, 'collaborators': [{'name': 'UNITAID', 'class': 'OTHER'}, {'name': 'AMS-PHPT Research Platform (Program for HIV Prevention and Treatment)', 'class': 'UNKNOWN'}, {'name': 'Joint Clinical Research Centre- Kampala', 'class': 'UNKNOWN'}, {'name': 'Baylor College of Medicine Childrens Foundation, Uganda', 'class': 'UNKNOWN'}, {'name': 'Epcentre Centre Mbarara Research Centre', 'class': 'UNKNOWN'}, {'name': 'Institute of Tropical Medicine, Belgium', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-01-21', 'type': 'RELEASE'}, {'date': '2022-03-23', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Drugs for Neglected Diseases'}}}}