Ignite Creation Date:
2025-12-24 @ 1:14 PM
Ignite Modification Date:
2025-12-30 @ 5:13 AM
Study NCT ID:
NCT04552795
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2020-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019259', 'term': 'Lamivudine'}], 'ancestors': [{'id': 'D016047', 'term': 'Zalcitabine'}, {'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': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D015224', 'term': 'Dideoxynucleosides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bfrost@uthscsa.edu', 'phone': '210-562-5037', 'title': 'Bess Frost, PhD', 'organization': 'UT Health San Antonio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '28 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Open-Label 3TC', 'description': '12 subjects administered once daily 300 mg 3TC for 24 weeks', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'SARS-CoV-2 Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mild muscle pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Gastrointestinal bleeding', 'notes': 'Gastrointestinal bleeding due to a peptic ulcer; subject was on daily aspirin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 12, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Reverse Transcriptase Activity From Baseline to 24 Weeks in Plasma of Study Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label 3TC', 'description': '12 subjects administered once daily 300 mg 3TC for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0074', 'spread': '0.03', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 24 weeks', 'description': 'The extent of 3TC target engagement was measured by calculating the change in reverse transcriptase activity in plasma of participants at baseline compared to week 24 using a modified version of the EnzCheck Reverse Transcriptase (RT) Assay.', 'unitOfMeasure': 'Enzyme units', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': '3TC CNS Penetration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label 3TC', 'description': '12 subjects administered once daily 300 mg 3TC for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0.502', 'groupId': 'OG000', 'lowerLimit': '0.0215', 'upperLimit': '0.850'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 weeks', 'description': 'CNS penetration was calculated based on the ratio of CSF to plasma levels of 3TC after 24 weeks of 3TC using High Performance Liquid Chromatography with tandem Mass Spectrometry (HPLC/MS/MS).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Three subjects removed due to missed blood or CSF draw; one subject removed based on the ROUT method of outlier analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Dementia Severity From Baseline to Week 24 of Treatment Based on the PACC-5 Z-score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Values prior to 3TC administration'}, {'id': 'OG001', 'title': 'POST-Treatment', 'description': 'Values after 24 weeks of 3TC administration'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.59', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '-0.59'}, {'value': '-1.59', 'groupId': 'OG001', 'lowerLimit': '-2', 'upperLimit': '-1.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 24 weeks', 'description': "The Preclinical Alzheimer Cognitive Composite (PACC-5) score is calculated as a mean normative Z-score across five measures, including MMSE (0-30), Logical Memory Delayed Recall (0-25), Digit-Symbol Coding Test (0-93), Category Fluency, and Free and Cued Selective Reminding Test (0-96). Although typically relegated to individuals with prodromal and asymptomatic disease, the PACC-5 was included given its sensitivity to Alzheimer's disease-specific cognitive change.To calculate the Z score for each patient; the formula is Z = (x - M)/SD, where x is the patient's verbal memory raw score and M and SD are the estimates from the previous step. Positive Z values indicate scores that are greater than the mean of the pooled sample, and negative values indicate scores that are less than the pooled mean.A Z-score of zero represents the mean for this study population. Negative values mean a worse outcome than the standard population.", 'unitOfMeasure': 'Z-score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label 3TC', 'description': '12 subjects administered 300 mg once daily 3TC for 24 weeks.'}], 'classes': [{'categories': [{'title': 'Gastrointestinal bleeding due to peptic ulcer', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No adverse events', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 24', 'description': 'Incidence of adverse and serious adverse events potentially due to study drug', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Treatment-Emergent Abnormal Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Open-Label 3TC', 'description': '12 subjects administered once daily 300 mg 3TC for 24 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 24', 'description': 'Blood pressure, heart rate, temperature, and respiration, are measured and any significant change of any of these vital signs that show a significant change from the baseline value are reported as an event.', 'unitOfMeasure': 'Events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Open-Label 3TC', 'description': '12 subjects will be administered a 300mg once daily oral tablet of 3TC for 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from University of Texas Health San Antonio outpatient clinics and through local flier/newspaper advertisements.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Open-Label 3TC', 'description': '12 subjects will receive 3TC, 300-mg, daily for 24 weeks.\n\n3TC: 12 subjects will be administered 3TC, 300mg once daily, via an oral tablet for 24 weeks.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Average age (min, max)', 'categories': [{'measurements': [{'value': '69.4', 'groupId': 'BG000', 'lowerLimit': '52', 'upperLimit': '83'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age group', 'categories': [{'title': '<= 65 years of age', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '65 - 74 years of age', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '75 - 84 years of age', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White, non-Hispanic', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'White, Hispanic', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Education Level', 'classes': [{'categories': [{'measurements': [{'value': '15.3', 'spread': '2.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Past Medical History', 'classes': [{'categories': [{'title': '<= 1 Comorbidities', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '2+ Comorbidities', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of Symptoms Prior to Trial', 'classes': [{'categories': [{'title': '<= 1 year', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': '1-2 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '3+ years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Average BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.2', 'spread': '4.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Concurrent Treatment with Donepezil', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-08', 'size': 2809646, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-13T12:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label, one arm study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2020-08-11', 'resultsFirstSubmitDate': '2024-05-03', 'studyFirstSubmitQcDate': '2020-09-10', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-07', 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Reverse Transcriptase Activity From Baseline to 24 Weeks in Plasma of Study Participants', 'timeFrame': 'Baseline to 24 weeks', 'description': 'The extent of 3TC target engagement was measured by calculating the change in reverse transcriptase activity in plasma of participants at baseline compared to week 24 using a modified version of the EnzCheck Reverse Transcriptase (RT) Assay.'}, {'measure': '3TC CNS Penetration', 'timeFrame': '24 weeks', 'description': 'CNS penetration was calculated based on the ratio of CSF to plasma levels of 3TC after 24 weeks of 3TC using High Performance Liquid Chromatography with tandem Mass Spectrometry (HPLC/MS/MS).'}], 'secondaryOutcomes': [{'measure': 'Change in Dementia Severity From Baseline to Week 24 of Treatment Based on the PACC-5 Z-score', 'timeFrame': 'Baseline to 24 weeks', 'description': "The Preclinical Alzheimer Cognitive Composite (PACC-5) score is calculated as a mean normative Z-score across five measures, including MMSE (0-30), Logical Memory Delayed Recall (0-25), Digit-Symbol Coding Test (0-93), Category Fluency, and Free and Cued Selective Reminding Test (0-96). Although typically relegated to individuals with prodromal and asymptomatic disease, the PACC-5 was included given its sensitivity to Alzheimer's disease-specific cognitive change.To calculate the Z score for each patient; the formula is Z = (x - M)/SD, where x is the patient's verbal memory raw score and M and SD are the estimates from the previous step. Positive Z values indicate scores that are greater than the mean of the pooled sample, and negative values indicate scores that are less than the pooled mean.A Z-score of zero represents the mean for this study population. Negative values mean a worse outcome than the standard population."}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Baseline to Week 24', 'description': 'Incidence of adverse and serious adverse events potentially due to study drug'}, {'measure': 'Incidence of Treatment-Emergent Abnormal Vital Signs', 'timeFrame': 'Baseline to Week 24', 'description': 'Blood pressure, heart rate, temperature, and respiration, are measured and any significant change of any of these vital signs that show a significant change from the baseline value are reported as an event.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease, Early Onset']}, 'descriptionModule': {'briefSummary': "The objective of the study is to evaluate the ability of (-)-L-2',3'-dideoxy-3'-thiacytidine (3TC) to engage its intended target, penetrate the central nervous system (CNS), suppress neurodegeneration, and assess safety and tolerability in patients with early stage Alzheimer's disease. This study will provide the initial data on target engagement and Alzheimer's disease-relevant outcomes for future trials.", 'detailedDescription': "This open label study of 3TC will collect initial proof-of-concept data on 3TC target engagement, CNS penetration, efficacy and safety in older adults with early stage Alzheimer's disease. If successful, data will be used to design a larger phase 2 clinical trial. The investigators aim to I) Quantify 3TC target engagement and CNS penetration, II) Determine if 3TC suppresses Alzheimer's disease-relevant outcomes, and III) Assess the safety and tolerability of 3TC in older individuals with early Alzheimer's disease. The study will consist of a screening/baseline period of 30 days pre-treatment, a 24-week open label treatment period, and a follow up visit one month following treatment. Visits to the clinic include a pre-treatment screening visit that includes a comprehensive neuropsychological exam, a tablet-based neuropsychological exam, and a blood draw. For eligible participants, a lumbar puncture will be performed on day one of treatment. Participants will visit the clinic on day one of treatment and at weeks 8, 16, and 24 of treatment to complete medication checks, physical examinations, tablet-based cognitive screening, and blood draw. At week 24 of treatment, patients will undergo a post-treatment comprehensive neuropsychological exam, a lumbar puncture to collect cerebrospinal fluid, and a blood draw. One month after the final dose of medication, participants will return to the clinic for a final safety assessment and disenrollment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged 50-99 years\n2. Clinical diagnosis of early Alzheimer's disease (Clinical Dementia Rating (CDR) = 0.5, Mini-Mental State Exam (MMSE) = 24-30)\n3. If using drugs to treat symptoms related to Alzheimer's disease, doses must be stable for at least eight weeks prior to screening visit 1\n4. Labs: Adequate blood cell counts (white blood cells: 4,000-111,000 cells per microliter (cells/mcL); absolute neutrophil count: 1,800-8,700 cells/mcL; platelets: 120-500 K/µL; hemoglobin 12.0-17.5 grams/dL); LFT's within 2x normal value; creatinine clearance test (CrCl) ≥ 50 mL/min; cholesterol (≤260 mg/dl), triglycerides≤ 400 mg/dl), and glucose control (HbA1c ≤ 8%). Prothrombin time/partial thromboplastin time/international normalized ratio (PT/PTT/INR) within normal limits\n5. Body mass index (BMI) within range of 19 - 35 kg/m2\n6. Must have a reliable informant or caregiver\n7. Participants must have no plans to travel that interfere with study visits\n\nExclusion Criteria:\n\n1. Any medical or neurologic condition (other than Alzheimer's Disease) that might be a contributing cause of the subject's cognitive impairment\n2. Clinically significant unstable psychiatric illness in the past six months\n3. Significant hearing, vision, or motor deficits that interfere with participation\n4. Alcohol or drug abuse/dependence in the past six months\n5. Stroke, transient ischemic attack, or unexplained loss of consciousness in the past six months\n6. Unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within the past six months\n7. Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities\n8. Diagnosis of HIV infection or AIDS (CD4 count \\< 200), HIV/Hepatitis B Virus (HBV) co-infection, HBV or human T-cell leukemia virus infection\n9. History of impaired renal or liver function\n10. Current use of memantine or sorbitol-containing products\n11. Individuals with HIV, HBV, or who have current/previous use of Nucleoside Reverse Transcriptase Inhibitors (NRTIs) or non-NRTIs.\n12. Poorly controlled blood pressure (BP) (systolic BP \\> 160, diastolic BP \\> 90 mmHg)\n13. Uncontrolled diabetes (HbA1c \\> 8%, or the current use of insulin)\n14. Significant systematic illness or infection in the past 30 days\n15. Pregnant women"}, 'identificationModule': {'nctId': 'NCT04552795', 'acronym': 'ART-AD', 'briefTitle': "Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center at San Antonio'}, 'officialTitle': "Pilot Study to Investigate the Safety and Feasibility of AntiRetroviral Therapy for Alzheimer's Disease (ART-AD)", 'orgStudyIdInfo': {'id': 'HSC20200396H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open-Label 3TC', 'description': '12 subjects will receive 3TC, 300-mg, daily for 24 weeks.', 'interventionNames': ['Drug: 3TC']}], 'interventions': [{'name': '3TC', 'type': 'DRUG', 'otherNames': ['Epivir', 'lamivudine'], 'description': '12 subjects will be administered 3TC, 300mg once daily, via an oral tablet for 24 weeks.', 'armGroupLabels': ['Open-Label 3TC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': "Glenn Biggs Institute for Alzheimer's & Neurodegenerative Diseases", 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Sam and Ann Barshop Institute for Longevity & Aging Studies', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Bess Frost, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univ of Texas Health Science Center at San Antonio'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After study completion, upon publication of data and on ClinicalTrials.gov 1 year after primary completion date of study.', 'ipdSharing': 'YES', 'description': 'Protocol, Published Data', 'accessCriteria': 'Data will be analyzed by the study investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center at San Antonio', 'class': 'OTHER'}, 'collaborators': [{'name': 'Owens Medical Research Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Associate Professor, Sam and Ann Barshop Instititute for Aging and Longevity Studies, Glenn Biggs Institute for Alzheimer's and Neurodegenerative Disorders, Department of Cell Systems and Anatomy", 'investigatorFullName': 'Bess Frost, PhD', 'investigatorAffiliation': 'The University of Texas Health Science Center at San Antonio'}}}}