HIV-1-infection Clinical Trial
— Test&TreatOfficial title:
A Test and Treat Strategy in Barcelona: A Prospective Study in New HIV Diagnosis.
Verified date | September 2023 |
Source | Fundacion Clinic per a la Recerca Biomédica |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | May 11, 2023 |
Est. primary completion date | May 11, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínic de Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Judit Pich Martínez | Gilead Sciences |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients non-eligible to receive any of the antiretroviral regimens within the first week since the HIV confirmation) at week 4 | Patients will be considered non-eligible if they meet one or more of the following creiteria at week 4:
Presence of HLA-B* 5701 or lack of HLA test Presence of HIV genotypic resistance mutations to at least one class of ARV drug that decrease efficacy of antiretroviral treatment CD4 count < 200 cells/mm3 Viral load > 100.000 copies/mL Comorbidities such as: Osteopenia measured by DXA (T score less than 1), medical history of cardiovascular risk measured by Framingham risk score > 10% at 10 years, Kidney function (eGFR <50mL/min), Concomitant medication that can cause potential interactions with ARV (evaluating the risk of drug-drug interactions for drugs no totally safe (green colour) using the Liverpool website for DDI) Hepatitis B (HBV) coinfection or lack of serology |
week 4 | |
Secondary | Proportion of patients who start Biktarvy within the first week since HIV confirmation at the first visit at the HIV unit. | week 4 | ||
Secondary | Days since first HIV test was performed until Biktarvy is initiated. | week 4 | ||
Secondary | Days since HIV confirmation (first visit at the HIV unit) until Biktarvy is initiated. | week 4 | ||
Secondary | Proportion of patients with plasma viral load (VIH-1 RNA) < 50 copies/mL at 4, 12, 24 and 48 weeks. | week 4, week 12, week 24 and week 48 | ||
Secondary | Changes from week 0 in CD4 and CD8 count and CD4/CD8 ratio at 24 and 48 weeks. | week 24 and week 48 | ||
Secondary | 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. | week 48 | ||
Secondary | 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. | week 24 and week 48 | ||
Secondary | Proportion of patients who attend all the study visits (including blood collection) at 24 and 48 weeks. | week 24 and week 48 | ||
Secondary | Changes from week 0 in subclinical obesity using dual x-ray absorptiometry at 48 weeks. | week 48 | ||
Secondary | Proportion of patients with treatment-related adverse events during the study period. | week 48 | ||
Secondary | Proportion of patients who discontinue study treatment due to adverse events at 48 weeks. | week 48 | ||
Secondary | Changes in treatment adherence using the Simplified Medication Adherence Questionnaire at each visit during all the study period. | week 48 | ||
Secondary | Patient perception of rapid start of Biktarvy therapy using a specific questionnaire (CESTA) at 48 weeks. | week 48 |
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