Clinical trial NCT04416906: A Test and Treat Strategy in New HIV Diagnosis.
Official title: A Test and Treat Strategy in Barcelona: A Prospective Study in New HIV Diagnosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV-1-infection
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2020-06-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label, single arm, single-centre prospective study
Primary purpose: TREATMENT

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 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.


Eligibility 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.

Primary outcomes:
measure: Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) at week 4
timeFrame: week 4
Secondary outcomes:
measure: Proportion of patients who start Biktarvy within the first week since HIV confirmation at the first visit at the HIV unit.
timeFrame: week 4
measure: Days since first HIV test was performed until Biktarvy is initiated.
timeFrame: week 4
measure: Days since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated.
timeFrame: week 4
measure: Proportion of patients with plasma viral load (VIH-1 RNA) < 50 copies/mL at 4, 12, 24 and 48 weeks.
timeFrame: week 4, week 12, week 24 and week 48
measure: Changes from week 0 in CD4 and CD8 count and CD4/CD8 ratio at 24 and 48 weeks.
timeFrame: week 24 and week 48
measure: Changes from baseline in systemic inflammatory and coagulation response evaluated by measurement of soluble markers including, but not limited to IL-6, ultrasensitive PCR, Dimer-D at 48 weeks.
timeFrame: week 48
measure: Changes from baseline in senescence response evaluated by measurement of soluble markers of senescence including, but not limited to, bcl-2 apoptosis marker at 24 and 48 weeks.
timeFrame: week 24 and week 48
measure: Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks.
timeFrame: week 24 and week 48
measure: Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks.
timeFrame: week 48
measure: Proportion of patients with treatment-related adverse events during the study period.
timeFrame: week 48
measure: Proportion of patients who discontinue study treatment due to adverse events at 48 weeks.
timeFrame: week 48
measure: Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period.
timeFrame: week 48
measure: Patient perception of rapid start of Biktarvy therapy using a specific questionnaire (CESTA) at 48 weeks.
timeFrame: week 48
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Torres Berta, MD
role: PRINCIPAL_INVESTIGATOR
References: