Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04416906 | A Test and Treat Strategy in New HIV Diagnosis. | PHASE3 | COMPLETED | 100 | — | — | Oct 5, 2020 | May 11, 2023 | Sep 18, 2023 | 1 | Spain |
| NCT06333808 | Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy | PHASE3 | ACTIVE NOT_RECRUITING | 577 | — | — | Mar 25, 2024 | Dec 1, 2029 | Nov 5, 2025 | 104 | United States, Argentina +12 |
| NCT05502341 | Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen | PHASE2 | ACTIVE NOT_RECRUITING | 689 | — | — | Aug 16, 2022 | Jul 1, 2028 | Oct 14, 2025 | 94 | United States, Argentina +13 |
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
| Arm | Type | Description |
|---|---|---|
| Biktarvy | EXPERIMENTAL | This is a fixed dose combination regimen containing 50 mg of Bictegravir + 200 mg of Emtricitabine + 25 mg of Tenofovir alafenamide. |
| Treatment Group 1: Bictegravir (BIC)/ Lenacapavir (LEN) (75/50 mg) + PTM B/F/TAF | EXPERIMENTAL | Blinded Phase: Participants will switch from bictegravir/emtricitabine/tenofovir (B/F/TAF) FDC tablets to BIC/LEN (75/50 mg) FDC tablets and placebo-to-match (PTM) B/F/TAF. Participants will receive a 2-day oral loading dose of LEN 600 mg on Day 1 and on Day 2, in addition to the daily doses of BIC/LEN FDC tablet starting on Day 1 up to end of blinded treatment (EBT) visit. Open-label (OL) Phase: Following treatment in the Blinded Phase, participants from Treatment Group 1 will receive BIC/LEN FDC tablets through Week 48 in the Open-label Phase. At the OL Week 48 visit, participants from Treatment Group 1 will be given the option to continue to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. |
| Treatment Group 2: B/F/TAF (50/200/25 mg) + PTM BIC/LEN | EXPERIMENTAL | Blinded Phase: Participants will continue with their B/F/TAF (50/200/25 mg) FDC tablets and start PTM BIC/LEN tablets on Day 1. Participants will receive PTM LEN tablets for 2 days (2 PTM LEN tablets on Day 1 and on Day 2. The blinded phase will continue until the EBT visit. Open Label Phase: Participants in Treatment Group 2 who complete the EBT visit will be given the option to enter the OL phase to receive BIC/LEN FDC tablets until the conclusion of the OL Phase. |
| Phase 2: Bictegravir (BIC) 75 mg + Lenacapavir (LEN) 25 mg | EXPERIMENTAL | Participants will switch from their stable baseline regimen (SBR) to a regimen of BIC 75 mg + LEN 25 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 25 mg starting on Day 1 up to the end of randomized treatment (ERT) visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg fixed dose combination (FDC). |
| Phase 2: BIC 75 mg + LEN 50 mg | EXPERIMENTAL | Participants will switch from their SBR to a regimen of BIC 75 mg + LEN 50 mg. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC 75 mg + LEN 50 mg starting on Day 1 up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC. |
| Phase 2: Stable Baseline Regimen (SBR) | ACTIVE_COMPARATOR | Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 24 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC. |
| Phase 3: BIC/LEN 75 mg/50 mg Fixed-dose Combination (FDC) | EXPERIMENTAL | Participants will switch from their SBR to a regimen of BIC/LEN 75 mg/50 mg FDC. Participants will receive a 2-day loading dose regimen of LEN 600 mg, in addition to the daily doses of BIC/LEN 75 mg/50 mg FDC starting on Day 1 up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC. |
| Phase 3: Stable Baseline Regimen | ACTIVE_COMPARATOR | Participants will continue with their SBR per prescription for up to the ERT visit, participants will be treated for at least 48 weeks during the Randomized Period. Following Randomized Period, the participants will have an option to participate in an Extension Period to receive BIC/LEN 75 mg/50 mg FDC. |
| Name | Type | Description |
|---|---|---|
| Biktarvy | 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 |
| Bictegravir | DRUG | Tablets administered orally without regard to food |
| Lenacapavir | DRUG | Tablets administered orally without regard to food |
| B/F/TAF | DRUG | Tablets administered orally without regard to food |
| Placebo to match B/F/TAF | DRUG | Tablets administered orally without regard to food |
| Placebo to match BIC/LEN | DRUG | Tablets administered orally without regard to food |
| BIC/LEN FDC | DRUG | Tablets administered orally without regard to food |
| Stable Baseline Regimen | DRUG | SBR will include a combination of antiretroviral (ARV) regimen. ARV regimen may include the following, except for participants taking a single tablet regimen or taking a complete parenteral regimen (Cabenuva). * Nucleos(t)ide Reverse Transcriptase Inhibitors: * Abacavir * Emtricitabine * Lamivudine * Tenofovir alafenamide * Tenofovir disoproxil fumarate * Zidovudine * Non-Nucleosite Reverse Transcriptase Inhibitors: * Delavirdine * Efavirenz * Nevirapine * Rilpivirine * Doravirine * Integrase Inhibitors: * Bictegravir * Cabotegravir * Dolutegravir * Elvitegravir * Raltegravir * Protease Inhibitors: * Atazanavir * Darunavir * Fosamprenavir * Indinavir * Lopinavir * Nelfinavir * Saquinavir * Tipranavir * Chemokine Co-receptor 5 (CCR5) Antagonist: * Maraviroc * Fusion Inhibitors: * Enfuvirtide * gp120 Attachment Inhibitor: * Fostemsavir * Anti-CD4 Monoclonal Antibodies: * Ibalizumab-uiyk |
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, a...