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Trial record 22 of 42 for:    " January 12, 2011":" February 11, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

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

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ClinicalTrials.gov Identifier: NCT01286740
Recruitment Status : Completed
First Posted : January 31, 2011
Results First Posted : April 19, 2013
Last Update Posted : April 26, 2013
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-1 Infection
Intervention Drug: FTC/RPV/TDF
Enrollment 50

Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 50
Enrolled and Treated 49
Week 12 (Primary Endpoint) 49
Completed 48
Not Completed 2
Reason Not Completed
Enrolled but not treated             1
Protocol Violation             1
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who enrolled and received at least one dose of study drug
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
38  (8.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
4
   8.2%
Male
45
  91.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Hispanic or Latino
10
  20.4%
Not Hispanic or Latino
39
  79.6%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants
White 40
Black or African American 6
Asian 3
Baseline HIV-1 RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 49 participants
< 50 Copies/mL 47
50 to < 400 Copies/mL 2
EFV plasma concentration  
Mean (Standard Deviation)
Unit of measure:  ng/mL
Number Analyzed 49 participants
2204.9  (1059.42)
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12 (FDA Snapshot Analysis)
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 12 was analyzed using the FDA snapshot analysis.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were enrolled into the study, received at least one dose of study drug and had no major protocol violation
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
100
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 24 was analyzed using the FDA snapshot analysis.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
100
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)
Hide Description The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 48 was analyzed using the FDA snapshot analysis.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 49
Measure Type: Number
Unit of Measure: percentage of participants
93.9
4.Secondary Outcome
Title Plasma Concentration of RPV and EFV at Week 1
Hide Description The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 1.
Time Frame Week 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 1 were analyzed.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 21
Mean (Standard Deviation)
Unit of Measure: ng/mL
RPV 31.6  (11.46)
EFV 234.5  (234.09)
5.Secondary Outcome
Title Plasma Concentration of RPV and EFV at Week 2
Hide Description The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 2.
Time Frame Week 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 2 were analyzed.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
RPV 52.3  (24.46)
EFV 78.5  (86.91)
6.Secondary Outcome
Title Plasma Concentration of RPV and EFV at Week 4
Hide Description The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 4.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 4 were analyzed.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: ng/mL
RPV 65.5  (33.19)
EFV 10.0  (17.97)
7.Secondary Outcome
Title Plasma Concentration of RPV and EFV at Week 6
Hide Description The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 6.
Time Frame Week 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable measurements for plasma concentrations of RPV and EFV at Week 6 were analyzed.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: ng/mL
RPV 67.8  (36.12)
EFV 1.9  (4.66)
8.Secondary Outcome
Title Plasma Concentration of RPV and EFV at Week 8
Hide Description The mean (SD) plasma concentration (ng/mL) of RPV and EFV was measured at Week 8.
Time Frame Week 8
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable measurements for plasma concentration of RPV and EFV at Week 8 were analyzed.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 28
Mean (Standard Deviation)
Unit of Measure: ng/mL
RPV 76.0  (35.80)
EFV NA [1]   (NA)
[1]
Values were below the limit of quantitation.
9.Secondary Outcome
Title Plasma Concentration of RPV at Week 12
Hide Description The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 12.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with measurements for plasma concentration of RPV at Week 12 were analyzed.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: ng/mL
89.0  (54.13)
10.Secondary Outcome
Title Plasma Concentration of EFV at Week 12
Hide Description 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
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable measurements for plasma concentration of EFV at Week 12 were analyzed.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 17
Mean (Inter-Quartile Range)
Unit of Measure: ng/mL
45.2 [1] 
(NA to NA)
[1]
Interquartile range values were below the limit of quantitation.
11.Secondary Outcome
Title Plasma Concentration of RPV at Week 24
Hide Description The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 24.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable measurements for plasma concentration of RPV at Week 24 were analyzed.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 23
Mean (Standard Deviation)
Unit of Measure: ng/mL
74.1  (37.99)
12.Secondary Outcome
Title Plasma Concentration of RPV at Week 36
Hide Description The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 36.
Time Frame Week 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable measurements for plasma concentration of RPV at Week 36 were analyzed.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: ng/mL
85.5  (34.31)
13.Secondary Outcome
Title Plasma Concentration of RPV at Week 48
Hide Description The mean (SD) plasma concentration (ng/mL) of RPV was measured at Week 48.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with evaluable measurements for plasma concentration of RPV at Week 48 were analyzed.
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description:
Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ng/mL
77.6  (34.83)
Time Frame Baseline to Week 48
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FTC/RPV/TDF
Hide Arm/Group Description Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
All-Cause Mortality
FTC/RPV/TDF
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FTC/RPV/TDF
Affected / at Risk (%)
Total   1/49 (2.04%) 
Cardiac disorders   
Bradycardia  1  1/49 (2.04%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/49 (2.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
FTC/RPV/TDF
Affected / at Risk (%)
Total   32/49 (65.31%) 
Gastrointestinal disorders   
Diarrhoea  1  8/49 (16.33%) 
Abdominal pain  1  4/49 (8.16%) 
Nausea  1  3/49 (6.12%) 
General disorders   
Fatigue  1  4/49 (8.16%) 
Infections and infestations   
Upper respiratory tract infection  1  7/49 (14.29%) 
Sinusitis  1  5/49 (10.20%) 
Pharyngitis  1  4/49 (8.16%) 
Syphilis  1  3/49 (6.12%) 
Urethritis  1  3/49 (6.12%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  4/49 (8.16%) 
Psychiatric disorders   
Insomnia  1  6/49 (12.24%) 
Anxiety  1  3/49 (6.12%) 
Depression  1  3/49 (6.12%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 15
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01286740     History of Changes
Other Study ID Numbers: GS-US-264-0111
First Submitted: January 27, 2011
First Posted: January 31, 2011
Results First Submitted: March 8, 2013
Results First Posted: April 19, 2013
Last Update Posted: April 26, 2013