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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02345226 | Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults | PHASE3 | COMPLETED | 881 | — | — | Jan 26, 2015 | Jan 2, 2019 | Jan 2, 2020 | 117 | United States, Belgium +7 |
| NCT02345252 | Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Adults Who Are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF) | PHASE3 | COMPLETED | 632 | — | — | Jan 26, 2015 | Jan 9, 2019 | Jan 2, 2020 | 117 | United States, Belgium +10 |
| NCT02121795 | Switch Study to Evaluate F/TAF in HIV-1 Positive Participants Who Are Virologically Suppressed on Regimens Containing FTC/TDF | PHASE3 | COMPLETED | 668 | — | — | May 6, 2014 | Mar 1, 2019 | Mar 12, 2020 | 78 | United States, Belgium +5 |
| NCT01309243 | Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults | PHASE3 | COMPLETED | 799 | — | — | Feb 1, 2011 | Feb 1, 2014 | Feb 25, 2015 | 151 | United States, Australia +12 |
| NCT01252940 | Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF | PHASE3 | COMPLETED | 482 | — | — | Nov 1, 2010 | Oct 1, 2014 | Dec 4, 2015 | 111 | United States, Austria +8 |
| NCT01286740 | Study to Evaluate Switching From a Regimen Consisting of the Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen (STR) to the Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate STR | PHASE2 | COMPLETED | 50 | — | — | Jan 1, 2011 | Mar 1, 2012 | Apr 26, 2013 | 18 | United States |
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the snapshot algorithm, which defines a participant's virologic response using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 was analyzed using the US FDA snapshot algorithm. The snapshot algorithm defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.
| Arm | Type | Description |
|---|---|---|
| FTC/RPV/TAF | EXPERIMENTAL | FTC/RPV/TAF plus EFV/FTC/TDF placebo for at least 96 weeks. |
| EFV/FTC/TDF | ACTIVE_COMPARATOR | EFV/FTC/TDF plus FTC/RPV/TAF placebo for at least 96 weeks. |
| Open Label Extension Phase | EXPERIMENTAL | After the Week 96 visit, participants will be given the option to receive open label FTC/RPV/TAF for up to an additional 48 weeks. In countries where FTC/RPV/TAF is not yet commercially available, participants will be given the option to receive open-label FTC/RPV/TAF and attend visits every 12 weeks until FTC/RPV/TAF becomes commercially available, or until Gilead elects to discontinue the study, whichever occurs first. |
| FTC/RPV/TDF | ACTIVE_COMPARATOR | FTC/RPV/TDF plus FTC/RPV/TAF placebo for at least 96 weeks. |
| F/TAF + 3rd Agent | EXPERIMENTAL | Participants will receive F/TAF (200/25 mg or 200/10 mg) plus FTC/TDF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks. Dosing of F/TAF will be dependent on the third agent of the participants' pre-existing treatment regimen. |
| FTC/TDF + 3rd Agent | ACTIVE_COMPARATOR | Participants will receive FTC/TDF plus F/TAF placebo while remaining on an allowed third antiretroviral agent of the participant's pre-existing treatment regimen, for 96 weeks. |
| SBR/Delayed Switch | EXPERIMENTAL | Participants will stay on baseline regimen (SBR; their existing treatment regimen of PI+RTV plus 2 NRTIs) at the beginning of the study through Week 24, and may switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit. |
| Name | Type | Description |
|---|---|---|
| FTC/RPV/TAF | DRUG | 200/25/25 mg FDC tablets administered orally once daily |
| EFV/FTC/TDF Placebo | DRUG | Tablets administered orally once daily |
| EFV/FTC/TDF | DRUG | 600/200/300 mg FDC tablets administered orally once daily |
| FTC/RPV/TAF Placebo | DRUG | Tablets administered orally once daily |
| FTC/RPV/TDF Placebo | DRUG | Tablets administered orally once daily |
| FTC/RPV/TDF | DRUG | 200/25/300 mg FDC tablets administered orally once daily |
| FTC/TDF | DRUG | 200/300 mg FDC tablets administered orally once daily |
| F/TAF | DRUG | Tablets administered orally once daily |
| Allowed third antiretroviral agent | DRUG | An allowed third antiretroviral agent of the participant's pre-existing regimen may include one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®). |
| FTC/TDF Placebo | DRUG | Tablets administered orally once daily |
| F/TAF Placebo | DRUG | Tablets administered orally once daily |
| PI | DRUG | Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir. PIs were administered according to prescribing information. |
| RTV | DRUG | Ritonavir (RTV) was administered according to prescribing information. |
| NRTIs | DRUG | NRTIs included abacavir, emtricitabine, Combivir (lamivudine/zidovudine, coformulated), Epzicom (abacavir/lamivudine, coformulated), lamivudine, stavudine, tenofovir DF, Truvada® (emtricitabine/tenofovir DF, coformulated), and zidovudine. NRTIs were administered according to prescribing information. |
Key Inclusion Criteria: * The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures * Currently receiving EFV/FTC/TDF FDC for ≥ 6 consecutive months preceding the screening visit * Documented plasma HIV-1 RNA levels \< 50 copi...