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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

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ClinicalTrials.gov Identifier: NCT01495702
Recruitment Status : Completed
First Posted : December 20, 2011
Results First Posted : January 26, 2015
Last Update Posted : January 7, 2016
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acquired Immunodeficiency Syndrome
HIV Infections
Interventions Drug: NNRTI
Drug: FTC/TDF
Drug: Stribild
Enrollment 439

Recruitment Details 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.
Pre-assignment Details 571 participants were screened.
Arm/Group Title Stribild NNRTI+FTC/TDF
Hide Arm/Group Description 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. 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.
Period Title: Randomized Phase
Started 292 147
Completed 266 119
Not Completed 26 28
Reason Not Completed
Randomized But Not Treated             1             4
Adverse Event             2             2
Death             1             0
Lack of Efficacy             2             0
Investigators Discretion             2             0
Withdrew Consent             10             18
Lost to Follow-up             4             3
Participant Noncompliance             1             0
Protocol Violation             3             1
Period Title: Extension Phase
Started 26 2
Completed 26 2
Not Completed 0 0
Arm/Group Title Stribild NNRTI+FTC/TDF Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 291 143 434
Hide Baseline Analysis Population Description
Safety Analysis Set: participants were randomized and received at least one dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 291 participants 143 participants 434 participants
42  (9.6) 40  (9.7) 41  (9.7)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 291 participants 143 participants 434 participants
< 40 years 114 74 188
≥ 40 to < 50 years 106 44 150
≥ 50 years 71 25 96
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 291 participants 143 participants 434 participants
Female
23
   7.9%
9
   6.3%
32
   7.4%
Male
268
  92.1%
134
  93.7%
402
  92.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 291 participants 143 participants 434 participants
American Indian or Alaska Native 2 0 2
Asian 4 9 13
Black or African Heritage 49 23 72
Native Hawaiian or Pacific Islander 1 0 1
White 231 109 340
Other 4 2 6
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 291 participants 143 participants 434 participants
Hispanic/Latino 30 16 46
Non-Hispanic/Latino 261 127 388
Not Permitted 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 291 participants 143 participants 434 participants
France 4 1 5
Portugal 2 4 6
United States 152 75 227
Puerto Rico 4 2 6
Canada 13 6 19
Spain 27 13 40
Belgium 14 7 21
Austria 6 3 9
Australia 8 4 12
Germany 24 10 34
United Kingdom 13 5 18
Italy 24 13 37
HIV-1 RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 291 participants 143 participants 434 participants
< 50 copies/mL 285 141 426
50 to < 200 copies/mL 4 2 6
200 to < 400 copies/mL 0 0 0
≥ 400 copies/mL 2 0 2
CD4+ Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 291 participants 143 participants 434 participants
586  (210.3) 593  (224.6) 588  (214.9)
CD4+ Cell Count Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 291 participants 143 participants 434 participants
≤ 50 cells/µL 0 0 0
51 to ≤ 200 cells/µL 4 1 5
201 to ≤ 350 cells/µL 26 20 46
351 to ≤ 500 cells/µL 75 33 108
> 500 cells/µL 186 89 275
HIV Disease Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 291 participants 143 participants 434 participants
Asymptomatic 225 115 340
Symptomatic HIV Infections 36 14 50
AIDS 30 14 44
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 48
Hide Description 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.
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Stribild NNRTI+FTC/TDF
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 290 143
Measure Type: Number
Unit of Measure: percentage of participants
93.4 88.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stribild, NNRTI+FTC/TDF
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The null hypothesis was that the Stribild group was at least 12% worse than the NNRTI+FTC/TDF group with respect to the percentage of participants maintaining HIV-1 RNA < 50 copies/mL at Week 48. The alternative hypothesis was that the Stribild group was less than 12% worse than the NNRTI+FTC/TDF group.
Statistical Test of Hypothesis P-Value 0.066
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 5.3
Confidence Interval (2-Sided) 95%
-0.5 to 12.0
Estimation Comments The 95% confidence interval (CI) for the difference was from unconditional exact method using 2 inverted 1-sided tests with the standardized statistic using StatXact.
2.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 96
Hide Description 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.
Time Frame Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Stribild NNRTI+FTC/TDF
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 290 143
Measure Type: Number
Unit of Measure: percentage of participants
86.6 80.4
3.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Stribild NNRTI+FTC/TDF
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 270 126
Mean (Standard Deviation)
Unit of Measure: cells/µL
56  (147.3) 58  (179.3)
4.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Stribild NNRTI+FTC/TDF
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 256 116
Mean (Standard Deviation)
Unit of Measure: cells/µL
83  (166.7) 101  (156.5)
Time Frame Baseline through end of study (average 90 weeks)
Adverse Event Reporting Description Safety Analysis Set participants were randomized and received at least 1 dose of study drug
 
Arm/Group Title Stribild (Randomized Phase) NNRTI+FTC/TDF (Randomized Phase) All Stribild
Hide Arm/Group Description

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.

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.

Adverse events for this reporting group include those occurring in all participants while receiving Stribild in the randomized and extension phases.
All-Cause Mortality
Stribild (Randomized Phase) NNRTI+FTC/TDF (Randomized Phase) All Stribild
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stribild (Randomized Phase) NNRTI+FTC/TDF (Randomized Phase) All Stribild
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/291 (8.25%)   7/143 (4.90%)   26/293 (8.87%) 
Blood and lymphatic system disorders       
Anaemia  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Febrile neutropenia  1  0/291 (0.00%)  0/143 (0.00%)  1/293 (0.34%) 
Lymphadenopathy  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Cardiac disorders       
Coronary artery stenosis  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Myocardial infarction  1  1/291 (0.34%)  2/143 (1.40%)  1/293 (0.34%) 
Myocardial ischaemia  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Gastrointestinal disorders       
Colitis  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Diarrhoea  1  0/291 (0.00%)  1/143 (0.70%)  0/293 (0.00%) 
Gastritis  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Nausea  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
General disorders       
Chest pain  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Pyrexia  1  0/291 (0.00%)  1/143 (0.70%)  0/293 (0.00%) 
Hepatobiliary disorders       
Bile duct stone  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Immune system disorders       
Drug hypersensitivity  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Hypersensitivity  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Infections and infestations       
Appendicitis  1  0/291 (0.00%)  2/143 (1.40%)  0/293 (0.00%) 
Gastroenteritis  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Pneumonia  1  0/291 (0.00%)  1/143 (0.70%)  0/293 (0.00%) 
Pyelonephritis  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Septic shock  1  1/291 (0.34%)  1/143 (0.70%)  1/293 (0.34%) 
Shigella infection  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Staphylococcal infection  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Urosepsis  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Injury, poisoning and procedural complications       
Alcohol poisoning  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Joint dislocation  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Laceration  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Rib fracture  1  0/291 (0.00%)  1/143 (0.70%)  0/293 (0.00%) 
Musculoskeletal and connective tissue disorders       
Osteoarthritis  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Colon cancer  1  0/291 (0.00%)  0/143 (0.00%)  1/293 (0.34%) 
Lung neoplasm malignant  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Metastases to liver  1  0/291 (0.00%)  0/143 (0.00%)  1/293 (0.34%) 
Nervous system disorders       
Cerebrovascular accident  1  0/291 (0.00%)  1/143 (0.70%)  0/293 (0.00%) 
Psychomotor hyperactivity  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Syncope  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Psychiatric disorders       
Completed suicide  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Delusion  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Drug abuse  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Stress  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Substance-induced psychotic disorder  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Suicidal ideation  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Suicide attempt  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Renal and urinary disorders       
Renal failure acute  1  1/291 (0.34%)  1/143 (0.70%)  1/293 (0.34%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Haemoptysis  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Pleural effusion  1  0/291 (0.00%)  1/143 (0.70%)  0/293 (0.00%) 
Pulmonary embolism  1  0/291 (0.00%)  1/143 (0.70%)  0/293 (0.00%) 
Respiratory failure  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Vascular disorders       
Deep vein thrombosis  1  0/291 (0.00%)  1/143 (0.70%)  0/293 (0.00%) 
Hypertensive crisis  1  0/291 (0.00%)  1/143 (0.70%)  0/293 (0.00%) 
Hypotension  1  1/291 (0.34%)  0/143 (0.00%)  1/293 (0.34%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stribild (Randomized Phase) NNRTI+FTC/TDF (Randomized Phase) All Stribild
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   154/291 (52.92%)   66/143 (46.15%)   154/293 (52.56%) 
Gastrointestinal disorders       
Diarrhoea  1  30/291 (10.31%)  11/143 (7.69%)  30/293 (10.24%) 
Nausea  1  24/291 (8.25%)  4/143 (2.80%)  24/293 (8.19%) 
General disorders       
Fatigue  1  19/291 (6.53%)  2/143 (1.40%)  19/293 (6.48%) 
Infections and infestations       
Nasopharyngitis  1  30/291 (10.31%)  17/143 (11.89%)  30/293 (10.24%) 
Sinusitis  1  21/291 (7.22%)  5/143 (3.50%)  21/293 (7.17%) 
Syphilis  1  17/291 (5.84%)  10/143 (6.99%)  17/293 (5.80%) 
Upper respiratory tract infection  1  33/291 (11.34%)  15/143 (10.49%)  33/293 (11.26%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  19/291 (6.53%)  5/143 (3.50%)  19/293 (6.48%) 
Back pain  1  23/291 (7.90%)  8/143 (5.59%)  23/293 (7.85%) 
Nervous system disorders       
Headache  1  29/291 (9.97%)  8/143 (5.59%)  29/293 (9.90%) 
Psychiatric disorders       
Insomnia  1  22/291 (7.56%)  11/143 (7.69%)  22/293 (7.51%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  24/291 (8.25%)  5/143 (3.50%)  24/293 (8.19%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
There were no limitations affecting the analysis or results.
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: NCT01495702     History of Changes
Other Study ID Numbers: GS-US-236-0121
2011-004963-56 ( EudraCT Number )
First Submitted: December 14, 2011
First Posted: December 20, 2011
Results First Submitted: December 31, 2014
Results First Posted: January 26, 2015
Last Update Posted: January 7, 2016