Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-28 @ 12:13 AM
Study NCT ID:
NCT01394133
Status:
WITHDRAWN
Last Update Posted:
2013-04-30
First Post:
2011-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': '5 mL of plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-29', 'studyFirstSubmitDate': '2011-07-12', 'studyFirstSubmitQcDate': '2011-07-12', 'lastUpdatePostDateStruct': {'date': '2013-04-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK parameters', 'timeFrame': '28 days', 'description': 'The area under the concentration time curve and minimum concentration for tenofovir, emtricitabine, atazanavir and ritonavir'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV Infected Women'], 'conditions': ['HIV Infected']}, 'descriptionModule': {'briefSummary': 'Data suggests that women taking drugs to treat human immunodeficiency virus (HIV) have higher amounts of drugs in their body compared with men taking the same dose of anti-HIV drugs. The reason for this higher drug exposure has not yet been determined. The primary purpose of this study is to examine whether a pharmacokinetics (factors that determine the amount of drug in the body) of anti-HIV drugs change during different phases of the menstrual cycle in women and ultimately result in higher amounts of drug in the body compared with men. In other words, we plan to examine whether changes in sex hormones throughout the menstrual cycle affect the amount of anti-HIV drugs in HIV infected women. The antiretroviral drugs atazanavir, ritonavir, tenofovir and emtricitabine will be studied.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-infected women will be selected from the primary care office', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV positive females between 21-40 years of age.\n* Subjects must be receiving anti-HIV regimen consisting of tenofovir, emtricitabine, atazanavir, and ritonavir for a minimum of 4 weeks prior to the study.\n* Subjects must have regular menstrual cycle (period), define at least 10 cycles a year, occurring approximately every 28 days+/- 4 days and cycle length varying by not more than 7 days.\n\nExclusion Criteria:\n\n* Subjects can not be breast feeding, pregnant, or taking oral contraceptives (birth control pills) for at least 3 months prior to the study.\n* Subjects may not have the intrauterine device (IUD), Mirena, in place to prevent pregnancy.'}, 'identificationModule': {'nctId': 'NCT01394133', 'briefTitle': 'Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Impact of Menstrual Cycle on Antiretroviral Pharmacokinetics in HIV-Infected Women', 'orgStudyIdInfo': {'id': 'F10102815'}, 'secondaryIdInfos': [{'id': '1K23AI074390-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1K23AI074390-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV+ Female', 'description': 'HIV infected women between 21-40 years of age, not receiving oral contraceptives.', 'interventionNames': ['Drug: Tenofovir, Emtricitabine, Atazanavir, Ritonavir']}], 'interventions': [{'name': 'Tenofovir, Emtricitabine, Atazanavir, Ritonavir', 'type': 'DRUG', 'description': 'Women will be receiving Tenofovir 300mg, Emtricitabine 200mg, Atazanavir 300mg, Ritonavir 100mg, one dose on 2 separate visits. These medications will not be prescribed from the physician and not provided by the study.', 'armGroupLabels': ['HIV+ Female']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jennifer King', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}