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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01475838
Recruitment Status : Completed
First Posted : November 21, 2011
Results First Posted : January 26, 2015
Last Update Posted : June 8, 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: PI
Drug: RTV
Drug: FTC/TDF
Drug: Stribild
Enrollment 438
Recruitment Details 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
Pre-assignment Details 632 participants were screened.
Arm/Group Title Stribild PI+RTV+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 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.
Period Title: Randomized Phase
Started 293 145
Completed 263 109
Not Completed 30 36
Reason Not Completed
Randomized but Not Treated             0             5
Adverse Event             6             1
Pregnancy             0             1
Investigators Discretion             1             2
Withdrew Consent             10             14
Lost to Follow-up             3             4
Participant Noncompliance             1             5
Protocol Violation             9             4
Period Title: Extension Phase
Started 42 20
Completed 41 20
Not Completed 1 0
Reason Not Completed
Participant Noncompliance             1             0
Arm/Group Title Stribild PI+RTV+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 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 of all reporting groups
Overall Number of Baseline Participants 293 140 433
Hide Baseline Analysis Population Description
Safety Analysis Set: participants were randomized and received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 293 participants 140 participants 433 participants
41  (9.7) 41  (8.9) 41  (9.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 293 participants 140 participants 433 participants
< 40 years 130 68 198
≥ 40 to < 50 years 109 49 158
≥ 50 years 54 23 77
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 293 participants 140 participants 433 participants
Female
43
  14.7%
19
  13.6%
62
  14.3%
Male
250
  85.3%
121
  86.4%
371
  85.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 293 participants 140 participants 433 participants
American Indian or Alaska Native 2 1 3
Asian 7 2 9
Black or African Heritage 43 20 63
White 234 113 347
Other 5 2 7
Not Permitted 2 2 4
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 293 participants 140 participants 433 participants
Hispanic or Latino 42 17 59
Non-Hispanic/Latino 249 123 372
Not Permitted 2 0 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 293 participants 140 participants 433 participants
Portugal 12 7 19
France 39 15 54
United States 84 40 124
Puerto Rico 3 2 5
Canada 5 3 8
Spain 28 21 49
Belgium 6 2 8
Austria 11 4 15
Germany 36 21 57
United Kingdom 13 1 14
Switzerland 12 8 20
Italy 44 16 60
HIV-1 RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 293 participants 140 participants 433 participants
< 50 copies/mL 291 137 428
50 to < 200 copies/mL 2 2 4
200 to < 400 copies/mL 0 0 0
≥ 400 copies/mL 0 1 1
CD4+ Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 293 participants 140 participants 433 participants
604  (274.6) 624  (269.9) 610  (272.9)
CD4+ Cell Count Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 293 participants 140 participants 433 participants
≤ 50 cells/µL 0 0 0
51 to ≤ 200 cells/µL 9 6 15
201 to ≤ 350 cells/µL 37 14 51
351 to ≤ 500 cells/µL 69 26 95
> 500 cells/µL 178 94 272
HIV Disease Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 293 participants 140 participants 433 participants
Asymptomatic 214 105 319
Symptomatic HIV Infections 38 17 55
AIDS 41 18 59
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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: Participants who were randomized and treated, and had no major eligibility criteria violations
Arm/Group Title Stribild PI+RTV+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 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.
Overall Number of Participants Analyzed 290 139
Measure Type: Number
Unit of Measure: percentage of participants
93.8 87.1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stribild, PI+RTV+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 PI+RTV+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 PI+RTV+FTC/TDF group.
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 6.7
Confidence Interval (2-Sided) 95%
0.4 to 13.7
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
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Stribild PI+RTV+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 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.
Overall Number of Participants Analyzed 290 139
Measure Type: Number
Unit of Measure: percentage of participants
86.9 69.8
3.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 48
Hide Description [Not Specified]
Time Frame Baseline; Week 48
Hide 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 PI+RTV+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 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.
Overall Number of Participants Analyzed 270 120
Mean (Standard Deviation)
Unit of Measure: cells/µL
40  (169.5) 32  (166.1)
4.Secondary Outcome
Title Change From Baseline in CD4+ Cell Count at Week 96
Hide Description [Not Specified]
Time Frame Baseline; Week 96
Hide 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 PI+RTV+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 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.
Overall Number of Participants Analyzed 255 104
Mean (Standard Deviation)
Unit of Measure: cells/µL
61  (196.5) 71  (173.4)
Time Frame Baseline through end of study (average 88 weeks)
Adverse Event Reporting Description Safety Analysis Set: participants were randomized and received at least 1 dose of study drug
 
Arm/Group Title Stribild PI+RTV+FTC/TDF 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 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.

Adverse events for this reporting group include those occurring in participants while receiving Stribild in the randomized and extension phases.
All-Cause Mortality
Stribild PI+RTV+FTC/TDF All Stribild
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Stribild PI+RTV+FTC/TDF All Stribild
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/293 (8.19%)   11/140 (7.86%)   24/313 (7.67%) 
Cardiac disorders       
Acute myocardial infarction  1  0/293 (0.00%)  1/140 (0.71%)  0/313 (0.00%) 
Endocrine disorders       
Goitre  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Eye disorders       
Visual acuity reduced  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Gastrointestinal disorders       
Abdominal pain  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Enteritis  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Gastric haemorrhage  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Rectal haemorrhage  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
General disorders       
Drug withdrawal syndrome  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Infections and infestations       
Anal abscess  1  0/293 (0.00%)  1/140 (0.71%)  0/313 (0.00%) 
Appendicitis  1  1/293 (0.34%)  1/140 (0.71%)  1/313 (0.32%) 
Bronchitis  1  0/293 (0.00%)  1/140 (0.71%)  0/313 (0.00%) 
Encephalitis  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Gastroenteritis  1  1/293 (0.34%)  1/140 (0.71%)  1/313 (0.32%) 
Gastroenteritis norovirus  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Infective exacerbation of chronic obstructive airways disease  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Penile abscess  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Pneumonia  1  2/293 (0.68%)  0/140 (0.00%)  2/313 (0.64%) 
Rectal abscess  1  0/293 (0.00%)  1/140 (0.71%)  0/313 (0.00%) 
Injury, poisoning and procedural complications       
Alcohol poisoning  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Radius fracture  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Toxicity to various agents  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Wound  1  0/293 (0.00%)  1/140 (0.71%)  0/313 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthritis reactive  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Myalgia  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Osteonecrosis  1  0/293 (0.00%)  1/140 (0.71%)  0/313 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bronchial carcinoma  1  0/293 (0.00%)  1/140 (0.71%)  0/313 (0.00%) 
Hodgkin's disease  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Invasive lobular breast carcinoma  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Metastases to liver  1  0/293 (0.00%)  1/140 (0.71%)  0/313 (0.00%) 
Transitional cell carcinoma  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Nervous system disorders       
Headache  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Transient ischaemic attack  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Psychiatric disorders       
Alcohol withdrawal syndrome  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Anxiety  1  0/293 (0.00%)  1/140 (0.71%)  0/313 (0.00%) 
Bipolar I disorder  1  0/293 (0.00%)  1/140 (0.71%)  0/313 (0.00%) 
Drug abuse  1  0/293 (0.00%)  1/140 (0.71%)  0/313 (0.00%) 
Major depression  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Psychotic disorder  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Suicide attempt  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Vascular disorders       
Arteriosclerosis  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Deep vein thrombosis  1  1/293 (0.34%)  0/140 (0.00%)  1/313 (0.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stribild PI+RTV+FTC/TDF All Stribild
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   169/293 (57.68%)   67/140 (47.86%)   169/313 (53.99%) 
Gastrointestinal disorders       
Diarrhoea  1  27/293 (9.22%)  11/140 (7.86%)  27/313 (8.63%) 
Nausea  1  22/293 (7.51%)  5/140 (3.57%)  22/313 (7.03%) 
Infections and infestations       
Gastroenteritis  1  11/293 (3.75%)  7/140 (5.00%)  11/313 (3.51%) 
Nasopharyngitis  1  39/293 (13.31%)  20/140 (14.29%)  39/313 (12.46%) 
Pharyngitis  1  16/293 (5.46%)  7/140 (5.00%)  16/313 (5.11%) 
Sinusitis  1  15/293 (5.12%)  6/140 (4.29%)  16/313 (5.11%) 
Syphilis  1  20/293 (6.83%)  6/140 (4.29%)  20/313 (6.39%) 
Upper respiratory tract infection  1  29/293 (9.90%)  8/140 (5.71%)  29/313 (9.27%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  15/293 (5.12%)  4/140 (2.86%)  15/313 (4.79%) 
Back pain  1  24/293 (8.19%)  4/140 (2.86%)  24/313 (7.67%) 
Nervous system disorders       
Headache  1  24/293 (8.19%)  10/140 (7.14%)  24/313 (7.67%) 
Psychiatric disorders       
Anxiety  1  19/293 (6.48%)  5/140 (3.57%)  20/313 (6.39%) 
Depression  1  18/293 (6.14%)  9/140 (6.43%)  18/313 (5.75%) 
Insomnia  1  13/293 (4.44%)  8/140 (5.71%)  13/313 (4.15%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  20/293 (6.83%)  6/140 (4.29%)  20/313 (6.39%) 
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
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences, Inc.
EMail: ClinicalTrialDisclosures@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01475838    
Other Study ID Numbers: GS-US-236-0115
2011-004483-30 ( EudraCT Number )
First Submitted: November 17, 2011
First Posted: November 21, 2011
Results First Submitted: January 8, 2015
Results First Posted: January 26, 2015
Last Update Posted: June 8, 2016