Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-28 @ 1:24 PM
Study NCT ID:
NCT06830668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-02-17
First Post:
2025-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Same-Day Restart of B/F/TAF in HIV Patients After NNRTI Discontinuation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'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': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-12', 'studyFirstSubmitDate': '2025-01-26', 'studyFirstSubmitQcDate': '2025-02-12', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of re-initiation of B/F/TAF', 'timeFrame': 'From enrollment to the end of treatment at 24 weeks', 'description': 'Evaluate the efficacy following the re-initiation of B/F/TAF as determined by the achievement of HIV-RNA undetectable (\\< 50 copies/ml).'}], 'secondaryOutcomes': [{'measure': 'Drug resistance status', 'timeFrame': 'From enrollment to the end of treatment at 48 weeks', 'description': 'Describe drug resistance status'}, {'measure': 'The reasons for discontinuation of prior therapy', 'timeFrame': 'From enrollment to the end of treatment at 1 week', 'description': 'Describe the reasons for discontinuation of prior therapy'}, {'measure': 'The efficacy of B/F/TAF', 'timeFrame': 'From enrollment to the end of treatment at Week 12, Week24 and Week 48', 'description': 'Evaluate the efficacy of B/F/TAF (achievement of HIV-1 RNA\\< 50 copies/ml and HIV-1 RNA \\< 200 copies/ml) among those participants rapidly restarting B/F/TAF'}, {'measure': 'The persistence on B/F/TAF .', 'timeFrame': 'From enrollment to the end of treatment at 48 weeks', 'description': 'Evaluate the persistence on B/F/TAF during the study period and describe the reasons for discontinuation of B/F/TAF if it happens.'}, {'measure': 'The changes in parameters of quality of life and treatment satisfaction', 'timeFrame': 'From enrollment to the end of treatment at Week24 and Week 48', 'description': 'Describe changes in parameters of quality of life and treatment satisfaction'}, {'measure': 'The safety and tolerability on B/F/TAF', 'timeFrame': 'From enrollment to the end of treatment at 48 weeks', 'description': 'Evaluate the safety and tolerability on B/F/TAF during the study period.'}, {'measure': 'The emergence of drug resistance', 'timeFrame': 'From enrollment to the end of treatment at 48 weeks', 'description': 'Describe the emergence of drug resistance developed during the study period.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HIV', 'HIV Infection'], 'conditions': ['HIV Infection', 'HIV']}, 'descriptionModule': {'briefSummary': 'In China, free first-line ART regimens typically consist of two nucleoside reverse transcriptase inhibitors (NRTIs) and a non-nucleoside reverse transcriptase inhibitor (NNRTI). As of the end of 2022, approximately 1.135 million individuals were receiving ART, achieving a coverage rate of 92.8%, largely due to participation in free treatment programs. However, around 36,000 patients have discontinued treatment, primarily due to side effects associated with Efavirenz (EFV), a common NNRTI. The challenges posed by side effects and resistance profiles of existing NNRTIs highlight the need for effective re-initiation of ART to improve overall treatment coverage. INSTIs, particularly B/F/TAF (Bictegravir/emtricitabine/tenofovir alafenamide), demonstrates effective viral suppression and a higher barrier to resistance than NNRTIs. B/F/TAF has shown efficacy in patients with resistance mutations, making it a strong candidate for same-day ART re-initiation, especially in resource-limited areas where genotypic resistance testing may be unavailable. This study aims to evaluate the feasibility and effectiveness of rapidly restarting B/F/TAF in patients with treatment interruptions from previous NNRTI regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with 18 years old or above.\n* Discontinuation of previous NNRTI based regimen for more than 90 days.\n* No known CrCl\\< 30mL/min or severe hepatic impairment.\n* No known or suspected resistance to BIC.\n* No known pregnancy\n\nExclusion Criteria:\n\n••Patients who are pregnant.\n\n* Patients who have abnormal liver and kidney function indicators(Child-pugh class C, CrCl\\< 30).Hepatitis virus co-infection does not serve as an exclusion criterion.\n* Patients who have historic resistance test indicating drug resistant to BIC or baseline resistance test indicating resistance to BIC.\n* Patients who are psychiatric illness or active tuberculosis co-infection.'}, 'identificationModule': {'nctId': 'NCT06830668', 'briefTitle': 'Same-Day Restart of B/F/TAF in HIV Patients After NNRTI Discontinuation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Center for AIDS/STD Control and Prevention, China CDC'}, 'officialTitle': 'Effectiveness and Persistence of Same-day Re-start with B/F/TAF Among Patients with HIV Who Experienced Discontinuation from Previous NNRTI Based Regimens in China', 'orgStudyIdInfo': {'id': 'CO-US-380-7381'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AIDS patients who discontinued NNRTI for more than 90 days', 'description': 'HIV patients of any gender, older than 18 years of age, who have been off their prior NNRTI regimen for more than 90 days and who have an HIV-1 viral load greater than 50 copies/uL.In this study, eligible patients will restart treatment on the same day and receive B/F/TAF for one year.We will conduct follow-ups on the patients and carry out routine clinical tests.', 'interventionNames': ['Drug: Regimen：BIC+FTC+TAF']}], 'interventions': [{'name': 'Regimen：BIC+FTC+TAF', 'type': 'DRUG', 'description': 'Same-day restart of "BIC+FTC+TAF" among HIV patients who experienced discontinuation from previous NNRTI-based regimens', 'armGroupLabels': ['AIDS patients who discontinued NNRTI for more than 90 days']}]}, 'contactsLocationsModule': {'locations': [{'zip': '102206', 'city': 'Chian', 'state': 'Beijing Municipality', 'country': 'China', 'contacts': [{'name': 'Yan Zhao, PhD', 'role': 'CONTACT', 'email': 'zhaoyan@chinaaids.cn', 'phone': '86-010-58900930'}], 'facility': 'National Center for AlDS/STD Control and Prevention,China CDC,NO.155, Changbai Road,Changping District,Beijing'}], 'centralContacts': [{'name': 'Yan Zhao, PhD', 'role': 'CONTACT', 'email': 'zhaoyan@chinaaids.cn', 'phone': '010-58900930'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for AIDS/STD Control and Prevention, China CDC', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}