HIV Primary Infection
Conditions
Keywords
Human Immunodeficiency Virus, HIV Primary Infection, Biktarvy
Brief summary
The purpose of this study is to assess the efficacy of Bictegravir/FTC/TAF in patients with less of 100 days post HIV infection
Detailed description
After providing informed consent, patients will undergo to a screening visit. If they meet the inclusion criteria and none of the exclusion will be included in this trial. Patients will take one tablet of Biktarvy at day for 48 weeks. Then the results will be compared with a cohort of 66 patients treated with 2 nucleoside analogues and one integrase chain transfer inhibitor.
Interventions
DRUG50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide
Patients will be administered one pill of 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide daily for 48 weeks with regular check-ups at weeks 4,8,12,24 and 48 including: * complete physical examination * register concomitant medication * blood test * concomitant medications * assessment od adverse events * assessement of compliance * PSQI and CESTA questionnaire (week 4 and 48) * Recommendation in contraception methods * Stool sample and pregnancy test urine (week 0 and 48) The total of blood required for each visit is 30ml except the visit of week 48 (90ml) The total of urine required is 6 mL
Sponsors
Anna Cruceta
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female patients aged 18-65 years * ART naïve * HIV infection of less than 100 days post-infection (documented 3 month previous negative serology or incomplete WB test with negative p31 band) * Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner.
Exclusion criteria
* Known hypersensitivity to any drug included in Bictegravir/FTC/TAF regimen * AST \>5 times UNL * Creatinine Clearance \<30 mL/min/1.73m2 * Any end-stage organ disease * Acute or chronic HCV co-infection * Use of PrEP with Truvada® until 4 weeks before the onset of symptoms of PHI (risk of acquired-drug resistance to FCT or TDF).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Portion of patients with a VL (viral load)< 50 Copies at week 48 | 48 weeks | Portion of patients with rapid ART (Antiretroviral therapy) initiation who reached a VL\< 50 copies at 48 week in the intention to treat population determined by PCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Portion of patients with > 900 cells CD4+ | weeks 24 and 48 | Proportion of patients with \>900 cells CD4+ |
| Days elapsed between diagnosis and bictegravir/FTC/TAF initiation | week 48 | Days elapsed between diagnosis and bictegravir/FTC/TAF initiation, day elapsed between first clinical visit and Bictegravir/FTC/TAF initiation |
| Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL<50 copies at 48 weeks in the intention-to-treat (ITT) population | week 48 | Proportion of patients treated with Bictegravir/FTC/TAF who reached a VL\<50 copies at 48 weeks in the intention-to-treat (ITT) population in comparison with other InSTI-, based ART regimens |
| AE (adverse event) leading to discontinuation rate | week 48 | AE leading to discontinuation rate in comparison with other InSTI- based ATR regimens |
| Viral Load at 4,8,12,24 y 48 weeks | weeks 4,8,12,24,48 | Determination by PCR (Polymerase Chain Reaction) of viral load at differents weeks of treatment |
| AE rate | week 48 | AE rate (overall and AE leading to discontinuation) |
| Number of required regimen changes | week 48 | Number of required regimen changes stratified by: adverse events/toxicity, virological failure, simplification, transmitted drug resistance (including polymorphisms for InSTIs). |
| Quality of life and satisfaction: questionnaire | day 0, week 4 and 48 | Quality of life and satisfaction evaluated through a CESTA questionnaire (Spanish Questionnaire of Satisfaction whit Antiretroviral Treatment) at 4 and 48 weeks (or at the end of study in case of early termination) of the study period, and Pittsburgh Sleep Quality Index (PSQI) at day 0, 4 week and 48 weeks (or at the end of study in case of early termination) of the study period |
| Viral reservoir, inflammatory and immunological markers and fecal microbiome composition | weeks 0,48 | Viral reservoir, inflammatory and immunological markers and fecal microbiome composition |
| CD4, CD4/CD8 ratio | weeks 4,8,12,24,48 | CD4, CD4/CD8 ratio at weeks 4,8,12,24 and 48 |
Countries
Spain
Contacts
Primary ContactAnna Cruceta, MD
Backup ContactJose María Miró, MD
Outcome results
None listed