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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01705574 | Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women | PHASE3 | COMPLETED | 583 | — | — | Oct 24, 2012 | Sep 6, 2018 | Sep 20, 2019 | 99 | United States, Belgium +10 |
| NCT01363011 | Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment | PHASE3 | COMPLETED | 106 | — | — | May 1, 2011 | Feb 1, 2015 | May 2, 2016 | 51 | United States, Australia +7 |
| NCT01497899 | Safety and Efficacy of E/C/F/TAF (Genvoya®) Versus E/C/F/TDF (Stribild®) in HIV-1 Infected, Antiretroviral Treatment-Naive Adults | PHASE2 | COMPLETED | 279 | — | — | Dec 28, 2011 | Aug 22, 2016 | Nov 19, 2018 | 41 | United States, Puerto Rico |
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 48 of the double-blind phase was analyzed using the snapshot algorithm, which defines a participant'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.
Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 1 (treatment-naive).
Change from baseline in eGFR-CG equation at Week 24 was analyzed in Cohort 2 (treatment-experienced).
Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m\^2 body surface area.
Change from baseline in eGFR-MDRD equation at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m\^2 body surface area.
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m\^2 body surface area.
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (not adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m\^2 body surface area.
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 1 (treatment-naive). The calculation was normalized to 1.73 m\^2 body surface area.
Change from baseline in eGFR-CKD-EPI based on cystatin C equation (adjusted for age, sex, and race) at Week 24 was analyzed in Cohort 2 (treatment-experienced). The calculation was normalized to 1.73 m\^2 body surface area.
Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 1 (treatment-naive). aGFR was calculated using iohexol plasma clearance.
Change from baseline in aGFR at Weeks 2, 4, and 24 was analyzed in Cohort 2 (treatment-experienced). aGFR was calculated using iohexol plasma clearance.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed in Cohort 1 (treatment-naive) using the FDA snapshot analysis algorithm.
The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 24 was analyzed in Cohort 2 (treatment-experienced) using the FDA snapshot analysis algorithm.
The percentage of participants achieving HIV-1 RNA \< 50 copies/mL at Week 24 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.
| Arm | Type | Description |
|---|---|---|
| E/C/F/TDF | EXPERIMENTAL | E/C/F/TDF + ATV placebo + RTV placebo + FTC/TDF placebo |
| ATV + RTV+ FTC/TDF | ACTIVE_COMPARATOR | ATV + RTV + FTC/TDF + E/C/F/TDF placebo |
| Open-Label Extension Phase | EXPERIMENTAL | After 48 weeks of blinded treatment, participants will continue to take blinded study drug for 12 weeks and return for an unblinding visit at Week 60. Participants who are virologically suppressed at Week 48 during the double-blinded treatment phase will have the option to enter the open-label extension phase. Participants randomized to the E/C/F/TDF arm will continue to receive open-label E/C/F/TDF and participants randomized to the ATV+ RTV + FTC/TDF arm will be re-randomized to receive either open-label elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or open-label ATV + RTV+ FTC/TDF. |
| E/C/F/TDF (Cohort 1) | EXPERIMENTAL | Participants who have not received prior antiretroviral (ARV) treatment and who are virologically unsuppressed at baseline will initiate treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) single-tablet regimen (STR) for up to 96 weeks. Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country. |
| COBI+PI+2 NRTI (Cohort 2) | EXPERIMENTAL | Participants who have received prior ARV treatment and who are virologically suppressed at baseline will continue their treatment regimen, switching the regimen's pharmacoenhancer component from ritonavir to cobicistat (COBI), and continuing their existing protease inhibitor (PI; either atazanavir (ATV) or darunavir (DRV)) plus 2 nucleoside reverse transcriptase inhibitor (NRTI) regimen for up to 96 weeks. Following Week 96, participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country. |
| E/C/F/TAF | EXPERIMENTAL | E/C/F/TAF plus E/C/F/TDF placebo for at least 48 weeks |
| E/C/F/TAF Open-Label | EXPERIMENTAL | Following study unblinding, participants from the E/C/F/TAF and E/C/F/TDF arms may have the option to receive E/C/F/TAF during an open-label extension phase. Also, participants who are actively participating in a Gilead-sponsored study of cobicistat-boosted darunavir plus nucleoside/nucleotide reverse transcriptase inhibitors (NRTI) who have reached the protocol-defined secondary endpoint (Week 48) and remain virologically suppressed are eligible to participate and receive E/C/F/TAF in this open-label extension phase. |
| Name | Type | Description |
|---|---|---|
| E/C/F/TDF | DRUG | 150/150/200/300 mg FDC tablet administered orally with food once daily |
| ATV | DRUG | 300 mg capsule administered orally with food once daily |
| RTV | DRUG | 100 mg tablet administered orally with food once daily |
| FTC/TDF | DRUG | 200/300 mg tablet administered orally with food once daily |
| E/C/F/TDF Placebo | DRUG | Tablet administered orally with food once daily |
| ATV Placebo | DRUG | Tablet administered orally with food once daily |
| RTV Placebo | DRUG | Capsule administered orally with food once daily |
| FTC/TDF Placebo | DRUG | Tablet administered orally with food once daily |
| E/C/F/TAF | DRUG | 150/150/200/10 mg FDC tablet administered orally with food once daily |
| COBI | DRUG | COBI 150 mg tablet administered with food orally once daily |
| DRV | DRUG | DRV 800 mg tablet administered orally once daily |
| NRTI | DRUG | Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or FTC/TDF, administered according to prescribing information. |
| E/C/F/TAF Placebo | DRUG | Tablet administered orally once daily |
Key Inclusion Criteria: * Female (at birth), age ≥ 18 years * Ability to understand and sign a written informed consent form * Plasma HIV-1 RNA levels ≥ 500 copies/mL * No prior use of any approved or investigational antiretroviral drug for any length of time * Screening genotype report must show s...