Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-04-16 @ 6:22 PM
Study NCT ID:
NCT01784302
Status:
COMPLETED
Last Update Posted:
2016-02-25
First Post:
2013-01-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Antacids and Multivitamins on Raltegravir
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-10-19', 'releaseDate': '2018-03-26'}, {'resetDate': '2019-03-01', 'releaseDate': '2018-10-30'}, {'resetDate': '2019-06-17', 'releaseDate': '2019-03-14'}], 'estimatedResultsFirstSubmitDate': '2018-03-26'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C067316', 'term': 'Geritol'}, {'id': 'D017693', 'term': 'Sodium Bicarbonate'}, {'id': 'C013591', 'term': 'aluminum hydroxide, magnesium hydroxide, drug combination'}, {'id': 'D000068898', 'term': 'Raltegravir Potassium'}], 'ancestors': [{'id': 'D001639', 'term': 'Bicarbonates'}, {'id': 'D002254', 'term': 'Carbonates'}, {'id': 'D002255', 'term': 'Carbonic Acid'}, {'id': 'D017554', 'term': 'Carbon Compounds, Inorganic'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-24', 'studyFirstSubmitDate': '2013-01-28', 'studyFirstSubmitQcDate': '2013-02-01', 'lastUpdatePostDateStruct': {'date': '2016-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in raltegravir Area under the curve (AUC)0-12h', 'timeFrame': 'Day 1, 6, 11, 16 and 21', 'description': 'The primary endpoint will be a change in raltegravir AUC0-12 h, following dosing of antacid or multivitamin'}], 'secondaryOutcomes': [{'measure': 'Measurement of gastrointestinal pH', 'timeFrame': 'Day 1, 6, 11, 16 and 21', 'description': 'Correlation between gastric pH and raltegravir pharmacokinetics'}, {'measure': 'Number of adverse events', 'timeFrame': 'Day 1 up to end of study Day 27'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'This study seeks to address the question of whether antacids or multivitamins influence the pharmacokinetics of raltegravir when co-administered. The aim of this study is to optimise the dosing of raltegravir when co-administered with antacids or multivitamins.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.\n* ≥ 18 years\n* Male or female subjects\n* A female may be eligible to enter and participate in the study if she:\n* Is of non-child-bearing potential defined as ether post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age)or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or\n* Is of child-bearing potential with a negative pregnancy test at screening and agrees to use one of the following methods of contraception to avoid pregnancy\n* Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study and for at least 4 weeks after discontinuation of all study medication\n* Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide)\n* Any intrauterine device (IUD) with published data showing that the expected failure rate is \\< 1 % per year\n* Any other method with published data showing that the expected failure rate is \\< 1 % per year\n* Hormonal contraception plus a barrier method. Hormonal contraception alone will not be considered adequate for inclusion into or participation in this study\n* Male subjects with a female partner of childbearing potential must agree to use effective contraception as above unless vasectomized\n* All subjects participating in the study will be counseled on safer sexual practices including the use of effective barrier methods (e.g. male condom)\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical condition\n* Pregnant or lactating women\n* Women of childbearing age unless using non hormonal contraception\n* Evidence of organ dysfunction or any clinically significant deviation from normal during screening including laboratory determinations\n* Abnormal LFTs (ALT \\> 2.5 x ULN, bilirubin \\> 1.5 x ULN)\n* Positive blood screen for HIV-1 and 2 antibodies\n* Positive blood screen for hepatitis B or C antibodies\n* Current or recent (within 3 months) gastrointestinal disease\n* Clinically relevant alcohol or drug use or history of alcohol or drug use that will hinder compliance with treatment, follow up procedures or evaluation of adverse effects\n* Use of proton pump inhibitors\n* Exposure to any investigational drug or placebo within 4 weeks of first dose of study drug\n* Consumption of grapefruit and oranges or products containing grapefruit or oranges within 1 week of first study drug and for the duration of the study\n* Use of any other drugs including over-the-counter medications and herbal preparations, within 2 weeks prior to first dose of study drug\n* Previous allergy to any of the constituents of the pharmaceuticals in this trial'}, 'identificationModule': {'nctId': 'NCT01784302', 'briefTitle': 'The Effect of Antacids and Multivitamins on Raltegravir', 'organization': {'class': 'OTHER', 'fullName': 'University of Liverpool'}, 'officialTitle': 'A 3 Arm, 5 Phase Study to Determine the Effect of Divalent and Monovalent Metal Containing Antacids and Multivitamins on the Pharmacokinetics of Raltegravir in Healthy Volunteers', 'orgStudyIdInfo': {'id': '4347'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Maalox Plus extra', 'description': 'Subjects will receive doses of raltegravir 400 mg and maalox plus extra', 'interventionNames': ['Drug: Maalox Plus extra', 'Drug: Raltegravir 400 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multivitamin', 'description': 'Subjects will receive doses of raltegravir 400 mg along with a multivitamin tablet', 'interventionNames': ['Dietary Supplement: Multivitamins', 'Drug: Raltegravir 400 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium bicarbonate', 'description': 'Subjects will receive doses of raltegravir 400 mg along with sodium bicarbonate', 'interventionNames': ['Dietary Supplement: Sodium bicarbonate', 'Drug: Raltegravir 400 mg']}], 'interventions': [{'name': 'Multivitamins', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Multivitamin']}, {'name': 'Sodium bicarbonate', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Sodium bicarbonate']}, {'name': 'Maalox Plus extra', 'type': 'DRUG', 'armGroupLabels': ['Maalox Plus extra']}, {'name': 'Raltegravir 400 mg', 'type': 'DRUG', 'armGroupLabels': ['Maalox Plus extra', 'Multivitamin', 'Sodium bicarbonate']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L7 8XP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Royal Liverpool University Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Saye Khoo, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Liverpool'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helen Reynolds', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research nurse', 'investigatorFullName': 'Helen Reynolds', 'investigatorAffiliation': 'University of Liverpool'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-03-26', 'type': 'RELEASE'}, {'date': '2018-10-19', 'type': 'RESET'}, {'date': '2018-10-30', 'type': 'RELEASE'}, {'date': '2019-03-01', 'type': 'RESET'}, {'date': '2019-03-14', 'type': 'RELEASE'}, {'date': '2019-06-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Helen Reynolds, Research nurse, University of Liverpool'}}}}