Status:
COMPLETED
A Test and Treat Strategy in New HIV Diagnosis.
Lead Sponsor:
Judit Pich Martínez
Collaborating Sponsors:
Gilead Sciences
Conditions:
HIV-1-infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is an open-label, single arm, single-centre prospective study to evaluate the feasibility, efficacy and safety of a once daily fixed dose combination regimen, Biktarvy, as a rapid treatment strat...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old.
- Having confirmed HIV-1 positive test.
- Patients not previously treated with antiretroviral treatment (post-exposure prophylaxis will be allowed if not done in the previous 6 months).
- Clinically stable patients, in the opinion of the investigator, at the time of inclusion.
- Women of child-bearing potential\* must have a negative pregnancy test in urine before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: hormonal contraceptive methods intrauterine device, bilateral tubal occlusion, vasectomized partner or sexual abstinence.
- Written informed consent.
Exclusion
- Pregnant or breastfeeding women at the time of the study inclusion or anticipating pregnancy during the follow-up period.
- Suspicion of an active opportunistic infection that defers initiating antiretroviral treatment \> 7 days since HIV confirmation.
- Known hypersensitivity or intolerance of any of the components of Biktarvy®.
- Patients on treatment with any prohibited medication (see section 5.2: Concomitant, nonpermitted and permitted medication).
- Any condition which, in the opinion of the principal investigator, may interfere with adequate understanding, cooperation or compliance with the study.
Key Trial Info
Start Date :
October 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04416906
Start Date
October 5 2020
End Date
May 11 2023
Last Update
September 18 2023
Active Locations (1)
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1
Hospital Clínic de Barcelona
Barcelona, Spain, 08036