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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AIDS patients who discontinued NNRTI for more than 90 days | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regimen:BIC+FTC+TAF | Drug | Same-day restart of "BIC+FTC+TAF" among HIV patients who experienced discontinuation from previous NNRTI-based regimens |
|
| Measure | Description | Time Frame |
|---|---|---|
| The efficacy of re-initiation of B/F/TAF | Evaluate the efficacy following the re-initiation of B/F/TAF as determined by the achievement of HIV-RNA undetectable (< 50 copies/ml). | From enrollment to the end of treatment at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Drug resistance status | Describe drug resistance status | From enrollment to the end of treatment at 48 weeks |
| The reasons for discontinuation of prior therapy | Describe the reasons for discontinuation of prior therapy |
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Inclusion Criteria:
Exclusion Criteria:
••Patients who are pregnant.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Zhao, PhD | Contact | 010-58900930 | zhaoyan@chinaaids.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center for AlDS/STD Control and Prevention,China CDC,NO.155, Changbai Road,Changping District,Beijing | Chian | Beijing Municipality | 102206 | China |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| From enrollment to the end of treatment at 1 week |
| The efficacy of B/F/TAF | 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 | From enrollment to the end of treatment at Week 12, Week24 and Week 48 |
| The persistence on B/F/TAF . | Evaluate the persistence on B/F/TAF during the study period and describe the reasons for discontinuation of B/F/TAF if it happens. | From enrollment to the end of treatment at 48 weeks |
| The changes in parameters of quality of life and treatment satisfaction | Describe changes in parameters of quality of life and treatment satisfaction | From enrollment to the end of treatment at Week24 and Week 48 |
| The safety and tolerability on B/F/TAF | Evaluate the safety and tolerability on B/F/TAF during the study period. | From enrollment to the end of treatment at 48 weeks |
| The emergence of drug resistance | Describe the emergence of drug resistance developed during the study period. | From enrollment to the end of treatment at 48 weeks |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |