Trial Outcomes & Findings for 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 (NCT NCT01286740)

NCT ID: NCT01286740

Last Updated: 2013-04-26

Results Overview

The percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2013-04-26

Participant Flow

Participants were enrolled at 18 sites in the United States. The first participant was screened on 27 January 2011. The last participant observation was on 26 June 2012.

63 participants were screened, 50 were enrolled; 49 participants were treated, and comprise the Safety Analysis set. Participants in the Safety Analysis Set who had no major protocol violation comprise the Full Analysis Set.

Participant milestones

Measure	FTC/RPV/TDF Participants switched from their existing treatment regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (tenofovir DF; TDF) to the FTC 200 mg/rilpivirine (RPV) 25 mg/TDF 300 mg single-table regimen (STR).
Overall Study STARTED	50
Overall Study Enrolled and Treated	49
Overall Study Week 12 (Primary Endpoint)	49
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	FTC/RPV/TDF Participants switched from their existing treatment regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (tenofovir DF; TDF) to the FTC 200 mg/rilpivirine (RPV) 25 mg/TDF 300 mg single-table regimen (STR).
Overall Study Enrolled but not treated	1
Overall Study Protocol Violation	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	FTC/RPV/TDF n=49 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Age Continuous	38 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized White	40 participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 participants n=5 Participants
Race/Ethnicity, Customized Asian	3 participants n=5 Participants
Baseline HIV-1 RNA Category < 50 Copies/mL	47 participants n=5 Participants
Baseline HIV-1 RNA Category 50 to < 400 Copies/mL	2 participants n=5 Participants
EFV plasma concentration	2204.9 ng/mL STANDARD_DEVIATION 1059.42 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Full Analysis Set: participants who were enrolled into the study, received at least one dose of study drug and had no major protocol violation

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.

Outcome measures

Measure	FTC/RPV/TDF n=49 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)	100 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Full Analysis Set

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.

Outcome measures

Measure	FTC/RPV/TDF n=49 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)	100 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Full Analysis Set

The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.

Outcome measures

Measure	FTC/RPV/TDF n=49 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)	93.9 percentage of participants

SECONDARY outcome

Timeframe: Week 1

Population: Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 1 were analyzed.

The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 1.

Outcome measures

Measure	FTC/RPV/TDF n=21 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Plasma Concentration of RPV and EFV at Week 1 EFV	234.5 ng/mL Standard Deviation 234.09
Plasma Concentration of RPV and EFV at Week 1 RPV	31.6 ng/mL Standard Deviation 11.46

SECONDARY outcome

Timeframe: Week 2

Population: Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 2 were analyzed.

The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 2.

Outcome measures

Measure	FTC/RPV/TDF n=26 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Plasma Concentration of RPV and EFV at Week 2 RPV	52.3 ng/mL Standard Deviation 24.46
Plasma Concentration of RPV and EFV at Week 2 EFV	78.5 ng/mL Standard Deviation 86.91

SECONDARY outcome

Timeframe: Week 4

Population: Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 4 were analyzed.

The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 4.

Outcome measures

Measure	FTC/RPV/TDF n=27 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Plasma Concentration of RPV and EFV at Week 4 RPV	65.5 ng/mL Standard Deviation 33.19
Plasma Concentration of RPV and EFV at Week 4 EFV	10.0 ng/mL Standard Deviation 17.97

SECONDARY outcome

Timeframe: Week 6

Population: Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 6 were analyzed.

The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 6.

Outcome measures

Measure	FTC/RPV/TDF n=27 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Plasma Concentration of RPV and EFV at Week 6 RPV	67.8 ng/mL Standard Deviation 36.12
Plasma Concentration of RPV and EFV at Week 6 EFV	1.9 ng/mL Standard Deviation 4.66

SECONDARY outcome

Timeframe: Week 8

Population: Participants with evaluable measurements for plasma concentration of RPV and EFV at Week 8 were analyzed.

The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 8.

Outcome measures

Measure	FTC/RPV/TDF n=28 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Plasma Concentration of RPV and EFV at Week 8 RPV	76.0 ng/mL Standard Deviation 35.80
Plasma Concentration of RPV and EFV at Week 8 EFV	NA ng/mL Standard Deviation NA Values were below the limit of quantitation.

SECONDARY outcome

Timeframe: Week 12

Population: Participants with measurements for plasma concentration of RPV at Week 12 were analyzed.

The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.

Outcome measures

Measure	FTC/RPV/TDF n=25 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Plasma Concentration of RPV at Week 12	89.0 ng/mL Standard Deviation 54.13

SECONDARY outcome

Timeframe: Week 12

Population: Participants with evaluable measurements for plasma concentration of EFV at Week 12 were analyzed.

The mean (SD) plasma concentration (ng/mL) of EFV was measured at Week 12. No analyses of EFV plasma concentrations were conducted after Week 12

Outcome measures

Measure	FTC/RPV/TDF n=17 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Plasma Concentration of EFV at Week 12	45.2 ng/mL Inter-Quartile Range 186.46 Interquartile range values were below the limit of quantitation.

SECONDARY outcome

Timeframe: Week 24

Population: Participants with evaluable measurements for plasma concentration of RPV at Week 24 were analyzed.

The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 24.

Outcome measures

Measure	FTC/RPV/TDF n=23 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Plasma Concentration of RPV at Week 24	74.1 ng/mL Standard Deviation 37.99

SECONDARY outcome

Timeframe: Week 36

Population: Participants with evaluable measurements for plasma concentration of RPV at Week 36 were analyzed.

The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 36.

Outcome measures

Measure	FTC/RPV/TDF n=18 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Plasma Concentration of RPV at Week 36	85.5 ng/mL Standard Deviation 34.31

SECONDARY outcome

Timeframe: Week 48

Population: Participants with evaluable measurements for plasma concentration of RPV at Week 48 were analyzed.

The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.

Outcome measures

Measure	FTC/RPV/TDF n=24 Participants Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Plasma Concentration of RPV at Week 48	77.6 ng/mL Standard Deviation 34.83

Adverse Events

FTC/RPV/TDF

Serious events: 1 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	FTC/RPV/TDF n=49 participants at risk Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Cardiac disorders Bradycardia	2.0% 1/49 • Baseline to Week 48
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.0% 1/49 • Baseline to Week 48

Other adverse events

Measure	FTC/RPV/TDF n=49 participants at risk Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Gastrointestinal disorders Diarrhoea	16.3% 8/49 • Baseline to Week 48
Gastrointestinal disorders Abdominal pain	8.2% 4/49 • Baseline to Week 48
Gastrointestinal disorders Nausea	6.1% 3/49 • Baseline to Week 48
General disorders Fatigue	8.2% 4/49 • Baseline to Week 48
Infections and infestations Upper respiratory tract infection	14.3% 7/49 • Baseline to Week 48
Infections and infestations Sinusitis	10.2% 5/49 • Baseline to Week 48
Infections and infestations Pharyngitis	8.2% 4/49 • Baseline to Week 48
Infections and infestations Syphilis	6.1% 3/49 • Baseline to Week 48
Infections and infestations Urethritis	6.1% 3/49 • Baseline to Week 48
Musculoskeletal and connective tissue disorders Back pain	8.2% 4/49 • Baseline to Week 48
Psychiatric disorders Insomnia	12.2% 6/49 • Baseline to Week 48
Psychiatric disorders Anxiety	6.1% 3/49 • Baseline to Week 48
Psychiatric disorders Depression	6.1% 3/49 • Baseline to Week 48

Additional Information

Clinical Trial Disclosures

Gilead Sciences, Inc.

Email: ClinicalTrialDisclosures@gilead.com

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