A Test and Treat Strategy in New HIV Diagnosis. (Test&Treat)

Judit Pich Martínez

Status and phase: Completed; Phase 3

Conditions: HIV-1-infection

Treatments: Drug: Biktarvy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04416906

Biktarvy Test&Treat

2019-004837-17 (EudraCT Number)

Details and patient eligibility

About

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 strategy in newly HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit Patients with confirmed HIV-1 diagnosis who wish to start ARV treatment immediately will receive bictegravir 50 mg + emtricitabine 200 mg + tenofovir alafenamide 25 mg within the first week since the HIV-1 confirmation during 48 weeks.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥ 18 years old.
2. Having confirmed HIV-1 positive test.
3. Patients not previously treated with antiretroviral treatment (post-exposure prophylaxis will be allowed if not done in the previous 6 months).
4. Clinically stable patients, in the opinion of the investigator, at the time of inclusion.
5. 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.
6. Written informed consent.

Exclusion criteria

1. Pregnant or breastfeeding women at the time of the study inclusion or anticipating pregnancy during the follow-up period.
2. Suspicion of an active opportunistic infection that defers initiating antiretroviral treatment > 7 days since HIV confirmation.
3. Known hypersensitivity or intolerance of any of the components of Biktarvy®.
4. Patients on treatment with any prohibited medication (see section 5.2: Concomitant, nonpermitted and permitted medication).
5. Any condition which, in the opinion of the principal investigator, may interfere with adequate understanding, cooperation or compliance with the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Biktarvy

Experimental group

Description:

This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide.

Treatment:

Drug: Biktarvy