Trial Outcomes & Findings for An Open Label Trial of Stribild for Antiretroviral (ARV)-naïve HIV-2 Infected Adults in Dakar, Senegal (NCT NCT02180438)
NCT ID: NCT02180438
Last Updated: 2018-07-26
Results Overview
Number of Participants Experiencing Death within the study period
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
48 weeks
Results posted on
2018-07-26
Participant Flow
Participant milestones
| Measure |
Open Label Prospective Single Arm Study of Stribild
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Open Label Prospective Single Arm Study of Stribild
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
Baseline Characteristics
An Open Label Trial of Stribild for Antiretroviral (ARV)-naïve HIV-2 Infected Adults in Dakar, Senegal
Baseline characteristics by cohort
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
49 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
Senegal
|
30 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 48 weeksNumber of Participants Experiencing Death within the study period
Outcome measures
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Death
|
0 Participants
|
PRIMARY outcome
Timeframe: 48 weeksNew AIDS defining event per WHO criteria
Outcome measures
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
New WHO Stage 3 or 4 Event
|
0 Participants
|
PRIMARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)
>50 copies/mL
|
1 Participants
|
|
Virologic Failure, FDA Snapshot (HIV-2 Plasma Viral Load >50 and >400 Copies/ml)
>400 copies/mL
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 weeksAdverse event per NIH/DAIDS criteria
Outcome measures
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Grade 3 or 4 Adverse Events
Lab: Grade 3 or 4
|
7 Participants
|
|
Grade 3 or 4 Adverse Events
Clinical: Grade 3 or 4
|
1 Participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
CD4 T-cell Count at 48 Weeks < Baseline
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
< 50 CD4 T-cell Increase at 48 Weeks From Baseline
|
2 Participants
|
SECONDARY outcome
Timeframe: 48 WeeksOutcome measures
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Switching Off Stribild Prior to 48 Weeks
|
0 Participants
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Development of Drug Resistance Mutations to Elvitegravir or Emtricitabine or Tenofovir DF
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Interim 24 Weeks Analysis of Death
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Interim Analysis at 24 Weeks of New WHO Stage 3 or 4 Event
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksVirologic failure, FDA Snapshot (HIV-2 plasma viral load \>50 and \>400 copies/ml)
Outcome measures
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Interim Analysis at 24 Weeks of HIV-2 Virologic Failure
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 weeksOutcome measures
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 Participants
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Interim Analysis at 24 Weeks of Grade 3 and 4 Adverse Events
|
0 Participants
|
Adverse Events
Open Label Prospective Single Arm Study of Stribild
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Open Label Prospective Single Arm Study of Stribild
n=30 participants at risk
Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks
|
|---|---|
|
Nervous system disorders
CVA
|
3.3%
1/30 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Geoffrey S Gottlieb. MD PhD (PI)
University of Washington
Phone: 1-206-616-2631
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place