Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection

Conditions
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HIV Primary Infection

Intervention / Treatment
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* Drug: 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged 18-65 years ART naïve HIV infection of less than 100 days post-infection (documented 3 month previous negative serology or incomplete WB test with negative p31 band) Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner. Exclusion Criteria: Known hypersensitivity to any drug included in Bictegravir/FTC/TAF regimen AST >5 times UNL Creatinine Clearance <30 mL/min/1.73m2 Any end-stage organ disease Acute or chronic HCV co-infection Use of PrEP with Truvada® until 4 weeks before the onset of symptoms of PHI (risk of acquired-drug resistance to FCT or TDF).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biktarvy<br>Patients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks | Drug: 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide<br>* 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: complete physical examination register concomitant medication blood test concomitant medications assessment od adverse events assessement of compliance PSQI and CESTA questionnaire (week 4 and 48) Recommendation in contraception methods Stool sample and pregnancy test urine (week 0 and 48) 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<br>* Other names: Biktarvy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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+ | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human Immunodeficiency Virus, HIV Primary Infection, Biktarvy