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

HIV Primary Infection Clinical Trial

— BIC-PHI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04483674
• Other study ID #: 2020-000601-89
• Status: Recruiting
• Phase: Phase 2
• Start date: December 4, 2020
• Est. completion date: June 2023

Study information

• Verified date: July 2021
• Source: Fundacion Clinic per a la Recerca Biomédica
• Contact: Anna Cruceta, MD
• Phone: 9322754000
• Email: acruceta[@]clinic.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• HIV Primary Infection
• Infection

Intervention

Drug:
• 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide
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

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Anna Cruceta

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Portion of patients with > 900 cells CD4+	Proportion of patients with >900 cells CD4+	weeks 24 and 48
Secondary	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
Secondary	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
Secondary	AE (adverse event) leading to discontinuation rate	AE leading to discontinuation rate in comparison with other InSTI- based ATR regimens	week 48
Secondary	CD4, CD4/CD8 ratio	CD4, CD4/CD8 ratio at weeks 4,8,12,24 and 48	weeks 4,8,12,24,48
Secondary	AE rate	AE rate (overall and AE leading to discontinuation)	week 48
Secondary	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
Secondary	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
Secondary	Viral reservoir, inflammatory and immunological markers and fecal microbiome composition	Viral reservoir, inflammatory and immunological markers and fecal microbiome composition	weeks 0,48