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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05917509 | A Study to Evaluate the Efficacy, Safety, Participant Choice and Preference of an Oral Once-daily Regimen or a Long-acting Injectable Regimen Every Two Months for Treatment of Human Immunodeficiency Virus (HIV-1) in Adults Who Have Not Previously Taken Antiretroviral Therapy | PHASE3 | COMPLETED | 171 | — | — | Jul 6, 2023 | Apr 20, 2026 | May 27, 2026 | 47 | United States, Argentina +7 |
| NCT04021290 | Regimen Switch to Dolutegravir/Lamivudine Fixed Dose Combination From Current Antiretroviral Regimen in HIV-1 Infected and Virologically Suppressed Adults (SALSA) | PHASE3 | COMPLETED | 493 | — | — | Nov 11, 2019 | Sep 9, 2022 | Oct 19, 2023 | 119 | United States, Argentina +15 |
| NCT03682848 | Safety and Efficacy of Dolutegravir/Lamivudine (DTG/3TC) in Therapy-naive Human Immunodeficiency Virus-1 (HIV-1) Infected Adolescents | PHASE3 | COMPLETED | 32 | — | — | May 6, 2019 | May 22, 2025 | Dec 9, 2025 | 8 | Kenya, South Africa +1 |
| NCT03446573 | Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO) | PHASE3 | COMPLETED | 743 | — | — | Jan 18, 2018 | May 3, 2022 | Jul 19, 2023 | 133 | United States, Australia +8 |
| NCT02422797 | Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-2) | PHASE3 | COMPLETED | 518 | — | — | Apr 21, 2015 | May 25, 2023 | Sep 3, 2024 | 61 | United States, Argentina +9 |
| NCT02429791 | Regimen Switch to Dolutegravir + Rilpivirine From Current Antiretroviral Regimen in Human Immunodeficiency Virus Type 1 Infected and Virologically Suppressed Adults (SWORD-1) | PHASE3 | COMPLETED | 510 | — | — | Apr 14, 2015 | May 30, 2023 | Sep 3, 2024 | 65 | United States, Argentina +11 |
| NCT02227238 | Comparative Efficacy and Safety Study of Dolutegravir and Lopinavir/Ritonavir in Second-line Treatment | PHASE3 | COMPLETED | 627 | — | — | Dec 11, 2014 | Feb 14, 2022 | Mar 13, 2023 | 59 | Argentina, Brazil +11 |
Number of participants with plasma HIV 1 RNA \>=50 c/mL were evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG/3TC FDC once daily compared to continuation of CAR over 48 weeks. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL ), along with study drug discontinuation status. Participants with plasma HIV 1 RNA \>=50 c/mL were termed as subjects with virologic failure. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.
Percentage of participants with plasma HIV-1 RNA \<50 c/mL was assessed at Week 48 according to the Food and Drug Administration (FDA) snapshot algorithm.
Percentage of participants with virologic failure (plasma HIV-1 RNA \>=50 c/mL) was evaluated using FDA snapshot algorithm at Week 48. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. Intent-to-treat exposed (ITT-E) Population comprises of all randomized participants who received at least one dose of study treatment either DTG + 3TC or TBR. Participants were assessed according to the treatment to which the participant was randomized. Any participant receiving a treatment randomization number was considered to be randomized.
Percentage of participants with plasma HIV 1 RNA \< 50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior antiviral activity of switching to DTG+RPV once daily compared to continuation of CAR over 48 weeks in HIV-1 infected antiretroviral therapy (ART)-experienced participants. Virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment within the window of the visit of interest. Plasma samples were collected for quantitative analysis of HIV-1 RNA.
Percentage of participants with plasma HIV 1 RNA \<50 c/mL at Week 48 using the Food and Drug Administration (FDA) snapshot algorithm was assessed to demonstrate the non-inferior activity of DTG plus 2 NRTI's compared to LPV/RTV plus 2 NRTI's. Analysis was performed on Intent-to-treat exposed (ITT-E) Population, which comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.
| Arm | Type | Description |
|---|---|---|
| Participants Receiving DTG/3TC Fixed Dose Combination (FDC) | EXPERIMENTAL | - |
| Participants Receiving CAB + RPV LA | EXPERIMENTAL | - |
| Participants receiving DTG/3TC FDC | EXPERIMENTAL | Eligible participants will be randomized to receive 50 milligrams (mg)/300 mg DTG/3TC FDC therapy from Day 1 up to 52 weeks. Participants who complete 52 weeks of treatment will have the opportunity to continue receiving DTG/3TC FDC once daily in the continuation phase. |
| Participants receiving CAR | ACTIVE_COMPARATOR | Eligible participants will continue to receive CAR from Day 1 up to 52 weeks. |
| DTG/3TC FDC | EXPERIMENTAL | Participants received dolutegravir/lamivudine (DTG/3TC) (50/300 mg) Fixed Dose Combination (FDC) tablets orally once daily. |
| DTG + 3TC 50 mg/300 mg | EXPERIMENTAL | Participants will receive a single tablet of a two-drug regimen of DTG 50 mg + 3TC 300 mg once daily from Day 1 through Week 200 (Early and Late Switch Phase). |
| TAF based regimen (TBR) | ACTIVE_COMPARATOR | Participants will continue their TBR from Day 1 to Week 148 (Early Switch Phase), and eligible participants will switch to DTG + 3TC once daily from Week 148 to 200 (Late Switch Phase). |
| Current antiretroviral regimen (CAR) | ACTIVE_COMPARATOR | Participants continued to receive their current antiretroviral regimen (two nucleoside reverse transcriptase inhibitor \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG 50 mg + RPV 25 mg once daily and were followed-up through the Late Switch Phase, at Week 148 and through the Continuation Phase, after Week 148. |
| DTG + RPV | EXPERIMENTAL | Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148). |
| DTG arm | EXPERIMENTAL | Subjects will receive one oral tablet of 50 mg DTG once daily plus two NRTIs selected by the investigator |
| LPV/RTV arm | ACTIVE_COMPARATOR | Subjects will receive four oral tablets of200/50 mg LPV/RTV once daily or two oral tablets of 200/50 mg LPV/RTV twice daily plus two NRTIs selected by the investigator |
| Name | Type | Description |
|---|---|---|
| DTG/3TC | DRUG | DTG/3TC FDC will be administered as an oral once daily tablet. |
| Cabotegravir (CAB) LA | DRUG | CAB LA will be administered as a gluteal intramuscular injection once every 2 months in combination with RPV LA. |
| Rilpivirine (RPV) LA | DRUG | RPV LA will be administered as a gluteal intramuscular injection once every 2 months in combination with CAB LA. |
| DTG/3TC FDC | DRUG | DTG/3TC FDC will be available as white, oval, film-coated tablets at a unit dose strength of 50 mg/300 mg. Participants will take DTG/3TC once daily via oral route. |
| CAR | DRUG | Participants who are randomized to the CAR arm will continue to take the current treatment until Week 52. CAR will include 2 NTRIs plus either an INI, NNRTI, or boosted PI or atazanavir unboosted. |
| DTG + 3TC FDC | DRUG | DTG + 3TC FDC was available as a 50/300 mg tablet to be given orally once daily. |
| DTG + 3TC | DRUG | DTG+3TC is supplied as white, oval, film-coated, fixed dose combination tablet. The tablets will be available in packed high density polyethylene (HDPE) bottles with induction seals and child-resistant closures. |
| TAF based regimen (TBR) | DRUG | Participants will continue to receive their TBR. |
| DTG 50 mg | DRUG | Participants received one oral tablet of 50 mg DTG daily administered concomitantly with RPV. Each DTG tablet contained 52.62 mg dolutegravir sodium salt, which was equivalent to 50 mg dolutegravir free acid. |
| RPV 25 mg | DRUG | Participants received DTG 50 milligrams (mg) + RPV 25 mg together once daily at approximately the same time, with a meal, in an open-label fashion up to Week 52 during early switch phase. Participants continued to receive DTG 50 mg + RPV 25 mg up to Week 148 during the Late Switch Phase. Participants who successfully completed 148 weeks of treatment were given the opportunity to continue to receive DTG + RPV once daily in the Continuation Phase (after Week 148), one oral tablet of 25 mg RPV daily administered concomitantly with DTG along with a meal. Each RPV tablet contained 27.5 mg of rilpivirine hydrochloride, which was equivalent to 25 mg of RPV. |
| DTG | DRUG | DTG is supplied as 50 mg tablets |
| LPV/RTV | DRUG | LPV/RTV is supplied as the LPV/RTV oral tablet, which contains 200 mg of LPV and 50 mg of RTV |
| Two NRTIs | DRUG | Investigators will choose a dual NRTI background regimen for each subject . In consultation with the medical monitor, 3TC may be added as a third NRTI to a dual-NRTI background regimen in subjects with chronic HBV infection and evidence of HIV resistance to 3TC |
Inclusion Criteria: 1. Participants with plasma HIV-1 RNA ≥1,000 c/mL at Screening. 2. Antiretroviral-naïve participants (defined as no prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) prior to enrolment. 3. Participant is capable of giving written informed cons...