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Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor (PI) and Two Nucleoside Reverse Transcriptase Inhibitors (NRTIs) to a Fixed-dose Tablet Containing Emtricitabine/Rilpivirine/Tenofovir DF

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01252940
First received: December 1, 2010
Last updated: October 27, 2015
Last verified: October 2015
Results First Received: March 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: HIV-1 Infection
Interventions: Drug: FTC/RPV/TDF
Drug: PI
Drug: RTV
Drug: NRTIs

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled at 110 sites in the North America and Europe. The first participant was screened on 17 November 2010. The last participant observation was on 28 October 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
617 participants were screened.

Reporting Groups
  Description
FTC/RPV/TDF Participants were randomized to switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.
SBR/Delayed Switch Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.

Participant Flow for 2 periods

Period 1:   Main Study Phase
    FTC/RPV/TDF     SBR/Delayed Switch  
STARTED     321     161  
Completed 24 Weeks     0     153 [1]
COMPLETED     295     149 [2]
NOT COMPLETED     26     12  
Randomized but not treated                 4                 2  
Adverse Event                 3                 1  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 6                 1  
Physician Decision                 1                 0  
Protocol Violation                 4                 2  
Withdrawal by Subject                 6                 5  
Subject Non-compliance                 1                 1  
[1] 152 participants switched regimens at Week 24.
[2] Discontinuations after switch: withdrawal by subject, 2; adverse event, 1; protocol violation, 1.

Period 2:   Extension Phase
    FTC/RPV/TDF     SBR/Delayed Switch  
STARTED     110 [1]   49 [2]
COMPLETED     100     46  
NOT COMPLETED     10     3  
Adverse Event                 2                 1  
Lack of Efficacy                 1                 0  
Lost to Follow-up                 5                 0  
Physician Decision                 0                 1  
Subject Non-compliance                 1                 0  
Withdrawal by Subject                 1                 1  
[1] FTC/RPV/TDF group: 110 participants completing the main study continued in extension phase.
[2] SBR/Delayed Switch Group: 49 participants completing the main study continued in extension phase.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Analysis Set: participants who were randomized and received at least one dose of study drug

Reporting Groups
  Description
FTC/RPV/TDF Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
SBR/Delayed Switch Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
Total Total of all reporting groups

Baseline Measures
    FTC/RPV/TDF     SBR/Delayed Switch     Total  
Number of Participants  
[units: participants]
  317     159     476  
Age  
[units: years]
Mean (Standard Deviation)
  41  (9.2)     43  (9.7)     42  (9.4)  
Gender  
[units: participants]
     
Female     44     15     59  
Male     273     144     417  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     51     31     82  
Not Hispanic or Latino     264     128     392  
Unknown or Not Reported     2     0     2  
Race/Ethnicity, Customized  
[units: participants]
     
White     241     124     365  
Black or African American     61     22     83  
American Indian or Alaska Native     3     2     5  
Asian     6     2     8  
Other     6     9     15  
Region of Enrollment [1]
[units: participants]
     
Austria     18     8     26  
Belgium     15     13     28  
Canada     15     10     25  
France     29     14     43  
Germany     31     12     43  
Italy     16     10     26  
Puerto Rico     16     2     18  
Spain     15     5     20  
United Kingdom     17     6     23  
United States     149     81     230  
Baseline HIV-1 RNA Category  
[units: participants]
     
< 50 Copies/mL     299     152     451  
50 to < 200 Copies/mL     10     6     16  
200 to < 400 Copies/mL     2     0     2  
400 to < 1000 Copies/mL     2     0     2  
≥ 1000 Copies/mL     4     1     5  
Stratification based on antiretroviral (ARV) use  
[units: participants]
     
TDF or FTC/TDF + lopinavir (LPV)/ritonavir (RTV)     82     49     131  
TDF or FTC/TDF + Other PI+RTV     178     81     259  
Non-TDF-containing regimen + LPV/RTV     15     9     24  
Non-TDF-containing regimen + Other PI+RTV     42     20     62  
[1] Four participants in the Switch to FTC/RPV/TDF group and 2 participants in the Stay on Baseline Regimen (SBR) group were randomized but were not treated. These subjects are included in the analysis of the baseline characteristic "Region of Enrollment" but are not included in the analysis of other baseline characteristics.



  Outcome Measures
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1.  Primary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 24 (FDA Snapshot Analysis)   [ Time Frame: Week 24 ]

2.  Secondary:   Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48 (FDA Snapshot Analysis)   [ Time Frame: Week 48 ]

3.  Secondary:   Change From Baseline in Cluster of Differentiation 4 (CD4) Count Through Week 24   [ Time Frame: Baseline to Week 24 ]

4.  Secondary:   Change From Baseline in CD4 Count Through Week 48   [ Time Frame: Baseline to Week 48 ]

5.  Secondary:   Change From Baseline in Fasting Total Cholesterol Through Week 24   [ Time Frame: Baseline to Week 24 ]

6.  Secondary:   Change From Baseline in Fasting Total Cholesterol Through Week 48   [ Time Frame: Baseline to Week 48 ]

7.  Secondary:   Change From Baseline in Fasting High-density Lipoprotein (HDL) Cholesterol Through Week 24   [ Time Frame: Baseline to Week 24 ]

8.  Secondary:   Change From Baseline in Fasting HDL Cholesterol Through Week 48   [ Time Frame: Baseline to Week 48 ]

9.  Secondary:   Change From Baseline in Fasting Direct Low-density Lipoprotein (LDL) Cholesterol Through Week 24   [ Time Frame: Baseline to Week 24 ]

10.  Secondary:   Change From Baseline in Fasting Direct LDL Cholesterol Through Week 48   [ Time Frame: Baseline to Week 48 ]

11.  Secondary:   Change From Baseline in Fasting Triglycerides Through Week 24   [ Time Frame: Baseline to Week 24 ]

12.  Secondary:   Change From Baseline in Fasting Triglycerides Through Week 48   [ Time Frame: Baseline to Week 48 ]


  Serious Adverse Events
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Time Frame Baseline through end of study (average 54 weeks)
Additional Description Safety Analysis Set: participants who were randomized and received at least one dose of study drug

Reporting Groups
  Description
FTC/RPV/TDF The adverse events reported in this group are those that occurred at any time during the study in participants who were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
SBR/Delayed Switch (up to Week 24) The adverse events reported in this group are those that occurred in the first 24 weeks of the study in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
SBR/Delayed Switch (After Week 24) The adverse events reported in this group are those that occurred after Week 24 in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at Week 24 visit.

Serious Adverse Events
    FTC/RPV/TDF     SBR/Delayed Switch (up to Week 24)     SBR/Delayed Switch (After Week 24)  
Total, serious adverse events        
# participants affected / at risk     21/317 (6.62%)     8/159 (5.03%)     9/152 (5.92%)  
Cardiac disorders        
Angina unstable † 1      
# participants affected / at risk     0/317 (0.00%)     0/159 (0.00%)     1/152 (0.66%)  
Myocardial infarction † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Palpitations † 1      
# participants affected / at risk     0/317 (0.00%)     0/159 (0.00%)     1/152 (0.66%)  
Eye disorders        
Visual acuity reduced † 1      
# participants affected / at risk     0/317 (0.00%)     1/159 (0.63%)     0/152 (0.00%)  
Gastrointestinal disorders        
Gastrointestinal haemorrhage † 1      
# participants affected / at risk     0/317 (0.00%)     0/159 (0.00%)     1/152 (0.66%)  
Pancreatitis † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
General disorders        
Chest pain † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     1/152 (0.66%)  
Pyrexia † 1      
# participants affected / at risk     1/317 (0.32%)     1/159 (0.63%)     0/152 (0.00%)  
Hepatobiliary disorders        
Cholecystitis † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Infections and infestations        
Acute sinusitis † 1      
# participants affected / at risk     0/317 (0.00%)     1/159 (0.63%)     0/152 (0.00%)  
Anal abscess † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Cellulitis † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Diverticulitis † 1      
# participants affected / at risk     0/317 (0.00%)     1/159 (0.63%)     0/152 (0.00%)  
Lung infection † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Parainfluenzae virus infection † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Pneumonia † 1      
# participants affected / at risk     3/317 (0.95%)     0/159 (0.00%)     0/152 (0.00%)  
Pneumonia bacterial † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Shigella infection † 1      
# participants affected / at risk     0/317 (0.00%)     1/159 (0.63%)     0/152 (0.00%)  
Subcutaneous abscess † 1      
# participants affected / at risk     0/317 (0.00%)     0/159 (0.00%)     1/152 (0.66%)  
Urosepsis † 1      
# participants affected / at risk     0/317 (0.00%)     1/159 (0.63%)     0/152 (0.00%)  
Viral infection † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Viral upper respiratory tract infection † 1      
# participants affected / at risk     0/317 (0.00%)     1/159 (0.63%)     0/152 (0.00%)  
Injury, poisoning and procedural complications        
Fall † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Meniscus injury † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Procedural pain † 1      
# participants affected / at risk     0/317 (0.00%)     0/159 (0.00%)     1/152 (0.66%)  
Stab wound † 1      
# participants affected / at risk     0/317 (0.00%)     1/159 (0.63%)     0/152 (0.00%)  
Investigations        
Blood creatine phosphokinase increased † 1      
# participants affected / at risk     0/317 (0.00%)     0/159 (0.00%)     1/152 (0.66%)  
Musculoskeletal and connective tissue disorders        
Arthralgia † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Arthritis reactive † 1      
# participants affected / at risk     0/317 (0.00%)     0/159 (0.00%)     1/152 (0.66%)  
Bursitis † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Muscular weakness † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Musculoskeletal chest pain † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Polyarthritis † 1      
# participants affected / at risk     0/317 (0.00%)     1/159 (0.63%)     0/152 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
Benign neoplasm of thyroid gland † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Nervous system disorders        
Hypoaesthesia † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Neuropathy peripheral † 1      
# participants affected / at risk     0/317 (0.00%)     0/159 (0.00%)     1/152 (0.66%)  
Sensory loss † 1      
# participants affected / at risk     0/317 (0.00%)     0/159 (0.00%)     1/152 (0.66%)  
Psychiatric disorders        
Bipolar disorder † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Substance-induced mood disorder † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Suicidal ideation † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     1/152 (0.66%)  
Renal and urinary disorders        
Nephropathy toxic † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Renal impairment † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Reproductive system and breast disorders        
Prostatism † 1      
# participants affected / at risk     0/317 (0.00%)     0/159 (0.00%)     1/152 (0.66%)  
Respiratory, thoracic and mediastinal disorders        
Acute respiratory failure † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Asthma † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Dyspnoea † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     1/152 (0.66%)  
Sleep apnoea syndrome † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Vascular disorders        
Arterial occlusive disease † 1      
# participants affected / at risk     1/317 (0.32%)     0/159 (0.00%)     0/152 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 17.0




  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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