Trial Outcomes & Findings for Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients (NCT NCT01475838)

Last Updated: 2016-06-08

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

438 participants

Primary outcome timeframe

Week 48

Results posted on

2016-06-08

Participant Flow

Participants were enrolled at study sites in North America and Europe. The first participant was screened on 18 November 2011. The last study visit occurred on 09 December 2014

632 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.	PI+RTV+FTC/TDF Participants stayed on their baseline treatment regimen consisting of a protease inhibitor (PI) (atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)) boosted with ritonavir (RTV) 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	293	145
Randomized Phase COMPLETED	263	109
Randomized Phase NOT COMPLETED	30	36
Extension Phase STARTED	42	20
Extension Phase COMPLETED	41	20
Extension Phase NOT COMPLETED	1	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.	PI+RTV+FTC/TDF Participants stayed on their baseline treatment regimen consisting of a protease inhibitor (PI) (atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)) boosted with ritonavir (RTV) 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	0	5
Randomized Phase Adverse Event	6	1
Randomized Phase Pregnancy	0	1
Randomized Phase Investigators Discretion	1	2
Randomized Phase Withdrew Consent	10	14
Randomized Phase Lost to Follow-up	3	4
Randomized Phase Participant Noncompliance	1	5
Randomized Phase Protocol Violation	9	4
Extension Phase Participant Noncompliance	1	0

Baseline Characteristics

Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination 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=293 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.	PI+RTV+FTC/TDF n=140 Participants Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV 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=433 Participants Total of all reporting groups
Age, Continuous	41 years STANDARD_DEVIATION 9.7 • n=5 Participants	41 years STANDARD_DEVIATION 8.9 • n=7 Participants	41 years STANDARD_DEVIATION 9.4 • n=5 Participants
Age, Customized < 40 years	130 participants n=5 Participants	68 participants n=7 Participants	198 participants n=5 Participants
Age, Customized ≥ 40 to < 50 years	109 participants n=5 Participants	49 participants n=7 Participants	158 participants n=5 Participants
Age, Customized ≥ 50 years	54 participants n=5 Participants	23 participants n=7 Participants	77 participants n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	19 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	250 Participants n=5 Participants	121 Participants n=7 Participants	371 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Race/Ethnicity, Customized Asian	7 participants n=5 Participants	2 participants n=7 Participants	9 participants n=5 Participants
Race/Ethnicity, Customized Black or African Heritage	43 participants n=5 Participants	20 participants n=7 Participants	63 participants n=5 Participants
Race/Ethnicity, Customized White	234 participants n=5 Participants	113 participants n=7 Participants	347 participants n=5 Participants
Race/Ethnicity, Customized Other	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Race/Ethnicity, Customized Not Permitted	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	42 participants n=5 Participants	17 participants n=7 Participants	59 participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic/Latino	249 participants n=5 Participants	123 participants n=7 Participants	372 participants n=5 Participants
Region of Enrollment Portugal	12 participants n=5 Participants	7 participants n=7 Participants	19 participants n=5 Participants
Region of Enrollment France	39 participants n=5 Participants	15 participants n=7 Participants	54 participants n=5 Participants
Region of Enrollment United States	84 participants n=5 Participants	40 participants n=7 Participants	124 participants n=5 Participants
Region of Enrollment Puerto Rico	3 participants n=5 Participants	2 participants n=7 Participants	5 participants n=5 Participants
Region of Enrollment Canada	5 participants n=5 Participants	3 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Spain	28 participants n=5 Participants	21 participants n=7 Participants	49 participants n=5 Participants
Region of Enrollment Belgium	6 participants n=5 Participants	2 participants n=7 Participants	8 participants n=5 Participants
Region of Enrollment Austria	11 participants n=5 Participants	4 participants n=7 Participants	15 participants n=5 Participants
Region of Enrollment Germany	36 participants n=5 Participants	21 participants n=7 Participants	57 participants n=5 Participants
Region of Enrollment United Kingdom	13 participants n=5 Participants	1 participants n=7 Participants	14 participants n=5 Participants
Region of Enrollment Switzerland	12 participants n=5 Participants	8 participants n=7 Participants	20 participants n=5 Participants
Region of Enrollment Italy	44 participants n=5 Participants	16 participants n=7 Participants	60 participants n=5 Participants
HIV-1 RNA Category < 50 copies/mL	291 participants n=5 Participants	137 participants n=7 Participants	428 participants n=5 Participants
HIV-1 RNA Category 50 to < 200 copies/mL	2 participants n=5 Participants	2 participants n=7 Participants	4 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	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
CD4+ Cell Count	604 cells/µL STANDARD_DEVIATION 274.6 • n=5 Participants	624 cells/µL STANDARD_DEVIATION 269.9 • n=7 Participants	610 cells/µL STANDARD_DEVIATION 272.9 • 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	9 participants n=5 Participants	6 participants n=7 Participants	15 participants n=5 Participants
CD4+ Cell Count Category 201 to ≤ 350 cells/µL	37 participants n=5 Participants	14 participants n=7 Participants	51 participants n=5 Participants
CD4+ Cell Count Category 351 to ≤ 500 cells/µL	69 participants n=5 Participants	26 participants n=7 Participants	95 participants n=5 Participants
CD4+ Cell Count Category > 500 cells/µL	178 participants n=5 Participants	94 participants n=7 Participants	272 participants n=5 Participants
HIV Disease Status Asymptomatic	214 participants n=5 Participants	105 participants n=7 Participants	319 participants n=5 Participants
HIV Disease Status Symptomatic HIV Infections	38 participants n=5 Participants	17 participants n=7 Participants	55 participants n=5 Participants
HIV Disease Status AIDS	41 participants n=5 Participants	18 participants n=7 Participants	59 participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Full Analysis Set: Participants who were randomized and treated, and had no major eligibility criteria violations

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.	PI+RTV+FTC/TDF n=139 Participants Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV 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	93.8 percentage of participants	87.1 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.	PI+RTV+FTC/TDF n=139 Participants Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV 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	86.9 percentage of participants	69.8 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.	PI+RTV+FTC/TDF n=120 Participants Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV 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	40 cells/µL Standard Deviation 169.5	32 cells/µL Standard Deviation 166.1

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=255 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.	PI+RTV+FTC/TDF n=104 Participants Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV 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	61 cells/µL Standard Deviation 196.5	71 cells/µL Standard Deviation 173.4

Adverse Events

Stribild

Serious events: 24 serious events

Other events: 169 other events

Deaths: 0 deaths

PI+RTV+FTC/TDF

Serious events: 11 serious events

Other events: 67 other events

Deaths: 0 deaths

All Stribild

Serious events: 24 serious events

Other events: 169 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

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

Measure	Stribild n=293 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.	PI+RTV+FTC/TDF n=140 participants at risk Adverse events for this reporting group include those occurring in participants receiving PI+RTV+FTC/TDF in the randomized phase. Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV 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=313 participants at risk Adverse events for this reporting group include those occurring in participants while receiving Stribild in the randomized and extension phases.
Gastrointestinal disorders Diarrhoea	9.2% 27/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	7.9% 11/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	8.6% 27/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Gastrointestinal disorders Nausea	7.5% 22/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	3.6% 5/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	7.0% 22/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Infections and infestations Gastroenteritis	3.8% 11/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	5.0% 7/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	3.5% 11/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Infections and infestations Nasopharyngitis	13.3% 39/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	14.3% 20/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	12.5% 39/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Infections and infestations Pharyngitis	5.5% 16/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	5.0% 7/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	5.1% 16/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Infections and infestations Sinusitis	5.1% 15/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	4.3% 6/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	5.1% 16/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Infections and infestations Syphilis	6.8% 20/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	4.3% 6/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	6.4% 20/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Infections and infestations Upper respiratory tract infection	9.9% 29/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	5.7% 8/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	9.3% 29/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Arthralgia	5.1% 15/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	2.9% 4/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	4.8% 15/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Musculoskeletal and connective tissue disorders Back pain	8.2% 24/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	2.9% 4/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	7.7% 24/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Nervous system disorders Headache	8.2% 24/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	7.1% 10/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	7.7% 24/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Psychiatric disorders Anxiety	6.5% 19/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	3.6% 5/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	6.4% 20/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Psychiatric disorders Depression	6.1% 18/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	6.4% 9/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	5.8% 18/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Psychiatric disorders Insomnia	4.4% 13/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	5.7% 8/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	4.2% 13/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
Respiratory, thoracic and mediastinal disorders Cough	6.8% 20/293 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	4.3% 6/140 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug	6.4% 20/313 • Baseline through end of study (average 88 weeks) Safety Analysis Set: participants were randomized and received at least 1 dose of study drug