A Test and Treat Strategy in New HIV Diagnosis.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2023-05-11

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV-1-infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

This is an open-label, single arm, single-centre prospective study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biktarvy

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

Group Type EXPERIMENTAL

Biktarvy

Intervention Type DRUG

Once daily fixed dose combination regimen of Biktarvy will be evaluated as a rapid treatment strategy in newly HIV diagnosed patients HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit

Interventions

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Biktarvy

Once daily fixed dose combination regimen of Biktarvy will be evaluated as a rapid treatment strategy in newly HIV diagnosed patients HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No