Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Portion of patients with a VL (viral load)< 50 Copies at week 48
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Biktarvy
Patients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks
Intervention: 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide (Drug)
Outcomes
Primary Outcomes
Portion of patients with a VL (viral load)< 50 Copies at week 48
Time Frame: 48 weeks
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
Secondary Outcomes
- Portion of patients with > 900 cells CD4+(weeks 24 and 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(week 48)
- AE rate(week 48)
- CD4, CD4/CD8 ratio(weeks 4,8,12,24,48)
- Number of required regimen changes(week 48)
- Viral Load at 4,8,12,24 y 48 weeks(weeks 4,8,12,24,48)
- Viral reservoir, inflammatory and immunological markers and fecal microbiome composition(weeks 0,48)
- Days elapsed between diagnosis and bictegravir/FTC/TAF initiation(week 48)
- AE (adverse event) leading to discontinuation rate(week 48)
- Quality of life and satisfaction: questionnaire(day 0, week 4 and 48)
Investigators
Anna Cruceta
Project Manager
Fundacion Clinic per a la Recerca Biomédica