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The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with less of 100 days post HIV infection
After providing informed consent, patients will undergo to a screening visit. If they meet the inclusion criteria and none of the exclusion will be included in this trial. Patients will take one tablet of Biktarvy at day for 48 weeks. Then the results will be compared with a cohort of 66 patients treated with 2 nucleoside analogues and one integrase chain transfer inhibitor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biktarvy | Experimental | Patients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide | Drug | Patients will be administered one pill of 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide daily for 48 weeks with regular check-ups at weeks 4,8,12,24 and 48 including:
The total of blood required for each visit is 30ml except the visit of week 48 (90ml) The total of urine required is 6 mL |
| Measure | Description | Time Frame |
|---|---|---|
| Portion of patients with a VL (viral load)< 50 Copies at week 48 | Portion of patients with rapid ART (Antiretroviral therapy) initiation who reached a VL< 50 copies at 48 week in the intention to treat population determined by PCR | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Load at 4,8,12,24 y 48 weeks | Determination by PCR (Polymerase Chain Reaction) of viral load at differents weeks of treatment | weeks 4,8,12,24,48 |
| Portion of patients with > 900 cells CD4+ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Cruceta, MD | Contact | 9322754000 | 4380 | acruceta@clinic.cat |
| Jose María Miró, MD | Contact | jmmiro@clinic.cat |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Recruiting | Barcelona | 08036 | Spain |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000620396 | bictegravir |
| C000654125 | bictegravir, emtricitabine, tenofovir alafenamide, drug combination |
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|
Proportion of patients with >900 cells CD4+
| weeks 24 and 48 |
| Days elapsed between diagnosis and bictegravir/FTC/TAF initiation | Days elapsed between diagnosis and bictegravir/FTC/TAF initiation, day elapsed between first clinical visit and Bictegravir/FTC/TAF initiation | week 48 |
| Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population | Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population in comparison with other InSTI-, based ART regimens | week 48 |
| AE (adverse event) leading to discontinuation rate | AE leading to discontinuation rate in comparison with other InSTI- based ATR regimens | week 48 |
| CD4, CD4/CD8 ratio | CD4, CD4/CD8 ratio at weeks 4,8,12,24 and 48 | weeks 4,8,12,24,48 |
| AE rate | AE rate (overall and AE leading to discontinuation) | week 48 |
| Number of required regimen changes | Number of required regimen changes stratified by: adverse events/toxicity, virological failure, simplification, transmitted drug resistance (including polymorphisms for InSTIs). | week 48 |
| Quality of life and satisfaction: questionnaire | Quality of life and satisfaction evaluated through a CESTA questionnaire (Spanish Questionnaire of Satisfaction whit Antiretroviral Treatment) at 4 and 48 weeks (or at the end of study in case of early termination) of the study period, and Pittsburgh Sleep Quality Index (PSQI) at day 0, 4 week and 48 weeks (or at the end of study in case of early termination) of the study period | day 0, week 4 and 48 |
| Viral reservoir, inflammatory and immunological markers and fecal microbiome composition | Viral reservoir, inflammatory and immunological markers and fecal microbiome composition | weeks 0,48 |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |