Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-01 @ 11:41 PM
Study NCT ID:
NCT05526118
Status:
UNKNOWN
Last Update Posted:
2022-09-02
First Post:
2022-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Advanced HIV: Outcomes for Rapid ART
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'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': 'D012897', 'term': 'Slow 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': 'C000654125', 'term': 'bictegravir, emtricitabine, tenofovir alafenamide, drug combination'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-08-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2025-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-30', 'studyFirstSubmitDate': '2022-07-25', 'studyFirstSubmitQcDate': '2022-08-30', 'lastUpdatePostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression', 'timeFrame': '48-72 weeks', 'description': 'Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: sex at birth'}, {'measure': 'post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression', 'timeFrame': '48-72 weeks', 'description': 'Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: age at HIV diagnosis'}, {'measure': 'post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression', 'timeFrame': '48-72 weeks', 'description': 'Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: CD4 nadir'}, {'measure': 'Post-hoc analyses to evaluate potential associations of baseline characteristics on viral suppression', 'timeFrame': '48-72 weeks', 'description': 'Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: initial HIV viral load'}, {'measure': 'Post-hoc analyses to evaluate potential associations of baseline characteristics on viral', 'timeFrame': '48-72 weeks', 'description': 'Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: patient reported treatment adherence'}, {'measure': 'Post-hoc analyses to evaluate potential associations of baseline characteristics on viral', 'timeFrame': '48-72 weeks', 'description': 'Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: medical insurance status'}, {'measure': 'Post-hoc analyses to evaluate potential associations of baseline characteristics on viral', 'timeFrame': '48-72 weeks', 'description': 'Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: housing status'}, {'measure': 'Post-hoc analyses to evaluate potential associations of baseline characteristics on viral', 'timeFrame': '48-72 weeks', 'description': 'Descriptive analysis will evaluate potential associations of baseline characteristics on primary endpoint outcomes/ HIV viral suppression: federal poverty level'}], 'primaryOutcomes': [{'measure': 'Viral Suppression', 'timeFrame': '24 weeks', 'description': 'To evaluate efficacy and time to HIV viral suppression of Biktarvy in Rapid Start setting for persons with Advanced HIV'}], 'secondaryOutcomes': [{'measure': 'Viral Suppression', 'timeFrame': '48 weeks', 'description': 'To evaluate efficacy, continued viral suppression of Biktarvy through 48 weeks.'}, {'measure': 'CD4 cell recovery', 'timeFrame': '48 weeks', 'description': 'Secondary objectives would be to evaluate immune function recovery via absolute CD4 cell count'}, {'measure': 'CD4 cell recovery', 'timeFrame': '48 weeks', 'description': 'Secondary objectives would be to evaluate immune function recovery via percent CD4 cell count'}, {'measure': 'CD4 cell recovery', 'timeFrame': '48 weeks', 'description': 'Secondary objectives would be to evaluate immune function recovery via CD4/CD8 ratio'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rapid start', 'rapid art initiation', 'bictegravir', 'hispanic', 'latinx', 'latinos', 'advanced HIV', 'AIDS'], 'conditions': ['HIV-1-infection']}, 'descriptionModule': {'briefSummary': 'AHORA is designed as a single-arm, open label, non-comparative, real-world prospective, observational study evaluating the outcomes for viral control and CD4 recovery/immune reconstitution in predominantly Hispanic/Latinx patients of the Rio Grande Valley (RGV) with advanced HIV who are rapidly initiated on bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy) at Valley AIDS Council (VAC) dba Westbrook Clinic (WBC). This research will help to fill data gaps still present for Biktarvy in a rapid start setting among an Hispanic/Latinx population, including those with advanced HIV.', 'detailedDescription': "VAC is the primary provider of HIV prevention, education and testing services and the only Ryan White funded agency providing medical care and supportive services for people with HIV in the RGV. VAC provides services to over 1700 patients with HIV, 52% of patients at VAC are diagnosed with advanced HIV disease. Generally speaking, HIV clinical trials have often lacked representation and enrollment of patients of Hispanic/Latinx ethnicity, and those with advanced HIV and this study has the potential to fill in those data gaps.\n\nFor AHORA, data from ART-naive, newly diagnosed HIV-1+ adults (18 years of age and older) with late presentation (CD4\\<200 or diagnosed Opportunistic infection/AIDS-defining illness) initiated on Biktarvy within 7 days from diagnosis will be collected and analyzed. Patients will be enrolled through VAC's linkage to care and RAPIDO (Rapid Start) programs. Patients appropriate for Rapid ART initiation with Biktarvy will be recruited, with a goal of 50 enrollees. Patients who agree to participate will have data collected at weeks 1,4,12, 24, 36, and 48 weeks for evaluation of time to viral suppression and efficacy, as well as evaluation of CD4 cell recovery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced HIV in the Rio Grande Valley (RGV) of Texas who are receiving treatment services with Valley AIDS Council (VAC) dba Westbrook Clinic (WBC). 92% of patients receiving services at VAC/WBC identify as Hispanic/Latinx.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ART-naive adults,18 years of age and older\n* diagnosed with HIV within 7 days of study entry\n* diagnosis of Advanced HIV: clinical (diagnosed Opportunistic Infection/AIDS-defining illness) or laboratory (CD4\\<200) diagnosis of advanced HIV.\n\nExclusion Criteria:\n\n* Known severe renal impairment (CrCl \\<30 mL/min/1.73 m2);\n* Known or suspected severe hepatic impairment or unstable liver disease (Child Pugh Class C);\n* Use of rifamycins for treatment of OIs\n* use of concomitant medications that would be contraindicated for coadministration with Biktarvy;\n* OI diagnosis requiring initiation of OI treatment for \\>7 days prior to initiation of ART.\n* pregnant at time of diagnosis'}, 'identificationModule': {'nctId': 'NCT05526118', 'acronym': 'AHORA', 'briefTitle': 'Advanced HIV: Outcomes for Rapid ART', 'organization': {'class': 'OTHER', 'fullName': 'Valley AIDS Council'}, 'officialTitle': 'Advanced HIV: Outcomes for Rapid ART', 'orgStudyIdInfo': {'id': 'VAC-AHORA-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AHORA group', 'description': 'All 50 prospective subjects are enrolled into a single cohort, all subjects must meet inclusion/exclusion criteria', 'interventionNames': ['Drug: Bictegravir/emtricitabine/tenofovir alafenamide']}], 'interventions': [{'name': 'Bictegravir/emtricitabine/tenofovir alafenamide', 'type': 'DRUG', 'otherNames': ['Biktarvy'], 'description': 'Patients who are ART-naive adults,18 years of age and older, diagnosed with HIV within 7 days of study entry who have a clinical (diagnosed Opportunistic Infection/AIDS-defining illness) or laboratory (CD4\\<200) diagnosis of advanced HIV, who are clinically appropriate for Rapid ART initiation, and are initiated on bic/f/taf per DHHS guidelines at their initial clinic visit will be monitored for time to viral suppression, efficacy and CD4 cell recovery over the course of 48 weeks.', 'armGroupLabels': ['AHORA group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dora A Martinez, MD', 'role': 'CONTACT', 'email': 'dmartinez@westbrookclinic.org', 'phone': '956-428-2653'}, {'name': 'Jaime Rebeles, LVN', 'role': 'CONTACT', 'email': 'jrebeles@westbrookclinic.org', 'phone': '956-367-3031'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Coded data will be kept by sponsor for potential future use if patient subject consents to their data being used for future research. Presently there is no plan to share IPD. However, data obtained through this study may be provided to qualified researchers with academic interest in HIV. Data shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Valley AIDS Council', 'class': 'OTHER'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}