Trial Outcomes & Findings for Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients (NCT NCT01495702)

Last Updated: 2016-01-07

Results Overview

The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

439 participants

Primary outcome timeframe

Week 48

Results posted on

2016-01-07

Participant Flow

Participants were enrolled at study sites in North America, Europe, and Australia. The first participant was screened on 13 December 2011. The last study visit occurred on 01 December 2014.

571 participants were screened.

Participant milestones

Participant milestones
Measure	Stribild Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	NNRTI+FTC/TDF Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
Randomized Phase STARTED	292	147
Randomized Phase COMPLETED	266	119
Randomized Phase NOT COMPLETED	26	28
Extension Phase STARTED	26	2
Extension Phase COMPLETED	26	2
Extension Phase NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Stribild Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	NNRTI+FTC/TDF Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
Randomized Phase Randomized But Not Treated	1	4
Randomized Phase Adverse Event	2	2
Randomized Phase Death	1	0
Randomized Phase Lack of Efficacy	2	0
Randomized Phase Investigators Discretion	2	0
Randomized Phase Withdrew Consent	10	18
Randomized Phase Lost to Follow-up	4	3
Randomized Phase Participant Noncompliance	1	0
Randomized Phase Protocol Violation	3	1

Baseline Characteristics

Study to Evaluate Switching From Regimens Consisting of a Nonnucleoside Reverse Transcriptase Inhibitor Plus Emtricitabine and Tenofovir DF to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stribild n=291 Participants Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	NNRTI+FTC/TDF n=143 Participants Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.	Total n=434 Participants Total of all reporting groups
Region of Enrollment United States	152 participants n=5 Participants	75 participants n=7 Participants	227 participants n=5 Participants
Region of Enrollment Puerto Rico	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Region of Enrollment Canada	13 participants n=5 Participants	6 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment Spain	27 participants n=5 Participants	13 participants n=7 Participants	40 participants n=5 Participants
Region of Enrollment Belgium	14 participants n=5 Participants	7 participants n=7 Participants	21 participants n=5 Participants
Region of Enrollment Austria	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants
Region of Enrollment Australia	8 participants n=5 Participants	4 participants n=7 Participants	12 participants n=5 Participants
Region of Enrollment Germany	24 participants n=5 Participants	10 participants n=7 Participants	34 participants n=5 Participants
Region of Enrollment United Kingdom	13 participants n=5 Participants	5 participants n=7 Participants	18 participants n=5 Participants
Region of Enrollment Italy	24 participants n=5 Participants	13 participants n=7 Participants	37 participants n=5 Participants
HIV-1 RNA Category < 50 copies/mL	285 participants n=5 Participants	141 participants n=7 Participants	426 participants n=5 Participants
HIV-1 RNA Category 50 to < 200 copies/mL	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
HIV-1 RNA Category 200 to < 400 copies/mL	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
HIV-1 RNA Category ≥ 400 copies/mL	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
CD4+ Cell Count	586 cells/µL STANDARD_DEVIATION 210.3 • n=5 Participants	593 cells/µL STANDARD_DEVIATION 224.6 • n=7 Participants	588 cells/µL STANDARD_DEVIATION 214.9 • n=5 Participants
CD4+ Cell Count Category ≤ 50 cells/µL	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
CD4+ Cell Count Category 51 to ≤ 200 cells/µL	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
CD4+ Cell Count Category 201 to ≤ 350 cells/µL	26 participants n=5 Participants	20 participants n=7 Participants	46 participants n=5 Participants
CD4+ Cell Count Category 351 to ≤ 500 cells/µL	75 participants n=5 Participants	33 participants n=7 Participants	108 participants n=5 Participants
CD4+ Cell Count Category > 500 cells/µL	186 participants n=5 Participants	89 participants n=7 Participants	275 participants n=5 Participants
HIV Disease Status Asymptomatic	225 participants n=5 Participants	115 participants n=7 Participants	340 participants n=5 Participants
HIV Disease Status Symptomatic HIV Infections	36 participants n=5 Participants	14 participants n=7 Participants	50 participants n=5 Participants
HIV Disease Status AIDS	30 participants n=5 Participants	14 participants n=7 Participants	44 participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Pacific Islander	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Race/Ethnicity, Customized White	231 participants n=5 Participants	109 participants n=7 Participants	340 participants n=5 Participants
Race/Ethnicity, Customized Other	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	30 participants n=5 Participants	16 participants n=7 Participants	46 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic/Latino	261 participants n=5 Participants	127 participants n=7 Participants	388 participants n=5 Participants
Race/Ethnicity, Customized Not Permitted	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Region of Enrollment France	4 participants n=5 Participants	1 participants n=7 Participants	5 participants n=5 Participants
Age, Continuous	42 years STANDARD_DEVIATION 9.6 • n=5 Participants	40 years STANDARD_DEVIATION 9.7 • n=7 Participants	41 years STANDARD_DEVIATION 9.7 • n=5 Participants
Age, Customized < 40 years	114 participants n=5 Participants	74 participants n=7 Participants	188 participants n=5 Participants
Age, Customized ≥ 40 to < 50 years	106 participants n=5 Participants	44 participants n=7 Participants	150 participants n=5 Participants
Age, Customized ≥ 50 years	71 participants n=5 Participants	25 participants n=7 Participants	96 participants n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	9 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	268 Participants n=5 Participants	134 Participants n=7 Participants	402 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Asian	4 participants n=5 Participants	9 participants n=7 Participants	13 participants n=5 Participants
Race/Ethnicity, Customized Black or African Heritage	49 participants n=5 Participants	23 participants n=7 Participants	72 participants n=5 Participants
Region of Enrollment Portugal	2 participants n=5 Participants	4 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Full Analysis Set: participants were randomized, received at least 1 dose of study drug, had no documented resistance, and were on an NNRTI at screening

The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.

Outcome measures

Outcome measures
Measure	Stribild n=290 Participants Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	NNRTI+FTC/TDF n=143 Participants Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48	93.4 percentage of participants	88.1 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Full Analysis Set

The FDA-defined Snapshot algorithm was used, which defines a patient's virologic response status using only the viral load at the predefined time point within an allowed window of time.

Outcome measures

Outcome measures
Measure	Stribild n=290 Participants Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	NNRTI+FTC/TDF n=143 Participants Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96	86.6 percentage of participants	80.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline; Week 48

Population: Participants in the Full Analysis Set with available data were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.

Outcome measures

Outcome measures
Measure	Stribild n=270 Participants Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	NNRTI+FTC/TDF n=126 Participants Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
Change From Baseline in CD4+ Cell Count at Week 48	56 cells/µL Standard Deviation 147.3	58 cells/µL Standard Deviation 179.3

SECONDARY outcome

Timeframe: Baseline; Week 96

Population: Participants in the Full Analysis Set with available data while on study drug were analyzed; the missing-equals-excluded approach where participants with missing data were excluded from the analysis.

Outcome measures

Outcome measures
Measure	Stribild n=256 Participants Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	NNRTI+FTC/TDF n=116 Participants Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
Change From Baseline in CD4+ Cell Count at Week 96	83 cells/µL Standard Deviation 166.7	101 cells/µL Standard Deviation 156.5

Adverse Events

Stribild (Randomized Phase)

Serious events: 24 serious events

Other events: 154 other events

Deaths: 0 deaths

NNRTI+FTC/TDF (Randomized Phase)

Serious events: 7 serious events

Other events: 66 other events

Deaths: 0 deaths

All Stribild

Serious events: 26 serious events

Other events: 154 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Stribild (Randomized Phase) n=291 participants at risk Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase. Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.	NNRTI+FTC/TDF (Randomized Phase) n=143 participants at risk Adverse events for this reporting group include those occurring in participants receiving NNRTI+FTC/TDF in the randomized phase. Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.	All Stribild n=293 participants at risk Adverse events for this reporting group include those occurring in all participants while receiving Stribild in the randomized and extension phases.
Gastrointestinal disorders Diarrhoea	10.3% 30/291 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	7.7% 11/143 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	10.2% 30/293 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug
Gastrointestinal disorders Nausea	8.2% 24/291 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	2.8% 4/143 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	8.2% 24/293 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug
General disorders Fatigue	6.5% 19/291 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	1.4% 2/143 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	6.5% 19/293 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug
Infections and infestations Nasopharyngitis	10.3% 30/291 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	11.9% 17/143 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	10.2% 30/293 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug
Infections and infestations Sinusitis	7.2% 21/291 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	3.5% 5/143 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	7.2% 21/293 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug
Infections and infestations Syphilis	5.8% 17/291 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	7.0% 10/143 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	5.8% 17/293 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug
Infections and infestations Upper respiratory tract infection	11.3% 33/291 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	10.5% 15/143 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	11.3% 33/293 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 19/291 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	3.5% 5/143 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	6.5% 19/293 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Back pain	7.9% 23/291 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	5.6% 8/143 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	7.8% 23/293 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug
Nervous system disorders Headache	10.0% 29/291 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	5.6% 8/143 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	9.9% 29/293 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug
Psychiatric disorders Insomnia	7.6% 22/291 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	7.7% 11/143 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	7.5% 22/293 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug
Respiratory, thoracic and mediastinal disorders Cough	8.2% 24/291 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	3.5% 5/143 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug	8.2% 24/293 • Baseline through end of study (average 90 weeks) Safety Analysis Set participants were randomized and received at least 1 dose of study drug

Additional Information

Clinical Trial Disclosures

Gilead Sciences, Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
Publication restrictions are in place

Restriction type: OTHER