A Test and Treat Strategy in New HIV Diagnosis.

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Judit Pich Martínez
• Collaborator: Gilead Sciences

Criteria

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.