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

NCT04483674 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2021-07-19

No results posted yet for this study

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

Conditions

  • HIV Primary Infection

Interventions

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

Sponsors & Collaborators

  • Anna Cruceta

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-04
Primary Completion
2022-11-30
Completion
2023-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04483674 on ClinicalTrials.gov