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

NCT ID: NCT04483674

Last Updated: 2021-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-04
• Study Completion Date: 2023-06-30

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.

Conditions

HIV Primary Infection

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Biktarvy

Patients will receive one pill with 50mg bictegravir/200mg emtricitabine /25mg tenofovir alafenamide orally once a day, for 48 weeks

Group Type: EXPERIMENTAL

50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide

Intervention Type: 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:

• 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Biktarvy

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anna Cruceta

OTHER

Sponsor Role: lead

Responsible Party

Anna Cruceta

Project Manager

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Hospital Clinic

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Anna Cruceta, MD

Role: CONTACT

acruceta@clinic.cat

9322754000 ext. 4380

Jose María Miró, MD

Role: CONTACT

jmmiro@clinic.cat

Other Identifiers

2020-000601-89

Identifier Type: -

Identifier Source: org_study_id