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An Open Label Trial of Stribild for Antiretroviral (ARV)-naïve HIV-2 Infected Adults in Dakar, Senegal (Stribild HIV-2)

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: NCT02180438
Recruitment Status : Completed
First Posted : July 2, 2014
Results First Posted : May 8, 2018
Last Update Posted : July 25, 2018
Sponsor:
Collaborators:
Clinique des Maladies Infectieuses Ibrahima DIOP Mar/CRCF, Centre Hospitalier Universitaire de Fann
Gilead Sciences
Information provided by (Responsible Party):
Geoffrey S. Gottlieb, University of Washington

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition HIV-2 Infection
Intervention Drug: Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Period Title: Overall Study
Started 30
Completed 29
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
49
(24 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female 24
Male 6
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
30
 100.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Senegal Number Analyzed 30 participants
30
1.Primary Outcome
Title Death
Hide Description Number of Participants Experiencing Death within the study period
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description:
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Primary Outcome
Title New WHO Stage 3 or 4 Event
Hide Description New AIDS defining event per WHO criteria
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description:
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3.Primary Outcome
Title Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description:
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
>50 copies/mL
1
   3.3%
>400 copies/mL
0
   0.0%
4.Secondary Outcome
Title Grade 3 or 4 Adverse Events
Hide Description Adverse event per NIH/DAIDS criteria
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description:
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Lab: Grade 3 or 4
7
  23.3%
Clinical: Grade 3 or 4
1
   3.3%
5.Secondary Outcome
Title CD4 T-cell Count at 48 Weeks < Baseline
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description:
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
6.Secondary Outcome
Title < 50 CD4 T-cell Increase at 48 Weeks From Baseline
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description:
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
2
   6.7%
7.Secondary Outcome
Title Switching Off Stribild Prior to 48 Weeks
Hide Description [Not Specified]
Time Frame 48 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description:
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
8.Secondary Outcome
Title Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF
Hide Description [Not Specified]
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description:
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
1
   3.3%
9.Other Pre-specified Outcome
Title Interim 24 Weeks Analysis of Death
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description:
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
0
10.Other Pre-specified Outcome
Title Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description:
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
11.Other Pre-specified Outcome
Title Interim Analysis at 24 Weeks of HIV-2 Virologic Failure
Hide Description Virologic failure, FDA Snapshot (HIV-2 plasma viral load >50 and >400 copies/ml)
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description:
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
12.Other Pre-specified Outcome
Title Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events
Hide Description [Not Specified]
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description:
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open Label Prospective Single Arm Study of Stribild
Hide Arm/Group Description Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
All-Cause Mortality
Open Label Prospective Single Arm Study of Stribild
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open Label Prospective Single Arm Study of Stribild
Affected / at Risk (%) # Events
Total   1/30 (3.33%)    
Nervous system disorders   
CVA  [1]  1/30 (3.33%)  1
Indicates events were collected by systematic assessment
[1]
stroke
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Open Label Prospective Single Arm Study of Stribild
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr. Geoffrey S Gottlieb. MD PhD (PI)
Organization: University of Washington
Phone: 1-206-616-2631
Responsible Party: Geoffrey S. Gottlieb, University of Washington
ClinicalTrials.gov Identifier: NCT02180438     History of Changes
Other Study ID Numbers: STUDY00000757
First Submitted: May 29, 2014
First Posted: July 2, 2014
Results First Submitted: April 7, 2018
Results First Posted: May 8, 2018
Last Update Posted: July 25, 2018