Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Open-Label Pilot Study to Evaluate Switching From a Regimen Consisting of Raltegravir Plus Emtricitabine/Tenofovir DF 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: NCT01533259
Recruitment Status : Completed
First Posted : February 15, 2012
Results First Posted : January 26, 2015
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acquired Immunodeficiency Syndrome
HIV Infections
Intervention Drug: Stribild
Enrollment 48
Recruitment Details Participants were enrolled at a total of 7 study sites in the United States. The first participant was screened on 31 January 2012. The last study visit occurred on 23 August 2013.
Pre-assignment Details 58 participants were screened.
Arm/Group Title Stribild
Hide Arm/Group Description Switch from existing treatment regimen to Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regiment (STR) once daily for 48 weeks
Period Title: Overall Study
Started 48
Completed 48
Not Completed 0
Arm/Group Title Stribild
Hide Arm/Group Description Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
Overall Number of Baseline Participants 48
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants
44  (8.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Female
2
   4.2%
Male
46
  95.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants
Hispanic or Latino
10
  20.8%
Not Hispanic or Latino
38
  79.2%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants
White 40
Black or African American 7
Asian 1
Baseline HIV-1 RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants
< 50 copies/mL 46
50 to < 200 copies/mL 2
CD4 Cell Count  
Mean (Standard Deviation)
Unit of measure:  cells/µL
Number Analyzed 48 participants
711  (265.9)
HIV Disease Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 48 participants
Asymptomatic 45
Symptomatic HIV Infection 1
AIDS 2
1.Primary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 12
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 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who received at least one dose of study drug and had no major protocol violations of study drug resistance at baseline.
Arm/Group Title Stribild
Hide Arm/Group Description:
Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
Overall Number of Participants Analyzed 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100.0
(92.6 to 100.0)
2.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs) and Graded Laboratory Abnormalities
Hide Description This outcome measure assessed the safety and tolerability profile of Stribild. Treatment-emergent adverse events (AEs) and graded laboratory abnormalities occurring from baseline up to 30 days following the last dose of study drug were summarized.
Time Frame Up to 48 weeks plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title Stribild
Hide Arm/Group Description:
Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
Overall Number of Participants Analyzed 48
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 89.6
Drug-related AE 25.0
Grade 3 or higher AE 4.2
Serious AE 2.1
Any laboratory abnormality 91.7
Grade 3 or 4 laboratory abnormality 4.2
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Weeks 24 and 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 Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Stribild
Hide Arm/Group Description:
Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
Overall Number of Participants Analyzed 48
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 24
100.0
(92.6 to 100.0)
Week 48
100.0
(92.6 to 100.0)
Time Frame Up to 48 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title Stribild
Hide Arm/Group Description Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
All-Cause Mortality
Stribild
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stribild
Affected / at Risk (%)
Total   1/48 (2.08%) 
General disorders   
Chest pain  1  1/48 (2.08%) 
Respiratory, thoracic and mediastinal disorders   
Emphysema  1  1/48 (2.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Stribild
Affected / at Risk (%)
Total   33/48 (68.75%) 
Gastrointestinal disorders   
Diarrhoea  1  5/48 (10.42%) 
General disorders   
Fatigue  1  5/48 (10.42%) 
Immune system disorders   
Seasonal Allergy  1  3/48 (6.25%) 
Infections and infestations   
Upper respiratory tract infection  1  10/48 (20.83%) 
Influenza  1  4/48 (8.33%) 
Folliculitis  1  3/48 (6.25%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  3/48 (6.25%) 
Bursitis  1  3/48 (6.25%) 
Nervous system disorders   
Headache  1  4/48 (8.33%) 
Hypoaesthesia  1  3/48 (6.25%) 
Psychiatric disorders   
Insomnia  1  6/48 (12.50%) 
Anxiety  1  5/48 (10.42%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 16
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: NCT01533259     History of Changes
Other Study ID Numbers: GS-US-236-0123
First Submitted: February 2, 2012
First Posted: February 15, 2012
Results First Submitted: January 16, 2015
Results First Posted: January 26, 2015
Last Update Posted: January 26, 2015