Bictegravir/FTC/TAF for the Treatment of Primary HIV Infection (BIC-PHI)

The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with less of 100 days post HIV infection

Study Overview

• Status: Recruiting
• Conditions: HIV Primary Infection
• Intervention / Treatment: Drug: 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide

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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Anna Cruceta, MD; Phone Number: 4380 9322754000; Email: acruceta@clinic.cat
• Study Contact Backup: Name: Jose María Miró, MD; Email: jmmiro@clinic.cat

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Recruiting
    • Hospital Clínic
    • Principal Investigator: Juan Ambrosioni, MD
    • Principal Investigator: Jose M Miró, MD
    • Sub-Investigator: Josep Mallolas, MD
    • Sub-Investigator: Sonsoles Sanchez
    • Sub-Investigator: Montserrat Plana
    • Sub-Investigator: Cristina Rovira
    • Sub-Investigator: Carmen Hurtado
    • Sub-Investigator: José Alcamí

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Biktarvy; 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; 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; Other Names: Biktarvy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Anna Cruceta

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2020
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: July 20, 2020
• First Submitted That Met QC Criteria: July 22, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2021
• Last Update Submitted That Met QC Criteria: July 16, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Human Immunodeficiency Virus; Biktarvy; HIV Primary Infection
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; HIV Infections; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Tenofovir; Emtricitabine
• Other Study ID Numbers: 2020-000601-89

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No