Trial Outcomes & Findings for Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals (NCT NCT02251236)
NCT ID: NCT02251236
Last Updated: 2019-10-31
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
14 participants
Primary outcome timeframe
Baseline
Results posted on
2019-10-31
Participant Flow
Participant milestones
| Measure |
Stribild Arm
Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
Genvoya Arm
Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.
Genvoya: To be administered orally, once daily with food.
|
Untreated Arm
Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
5
|
0
|
|
Overall Study
COMPLETED
|
9
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Elvitegravir (EVG) Cerebrospinal Fluid (CSF) Pharmacokinetics in HIV-Infected Individuals
Baseline characteristics by cohort
| Measure |
Stribild Arm
n=9 Participants
Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
Genvoya Arm
n=5 Participants
Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.
Genvoya: To be administered orally, once daily with food.
|
Untreated Arm
Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34 years
n=5 Participants
|
45 years
n=7 Participants
|
—
|
34.5 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
1 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
—
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Plasma HIV RNA ≤ 40 copies/mL
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
14 Participants
n=4 Participants
|
|
CD4+ T-cell Count
|
601 cells/µL
n=5 Participants
|
784 cells/µL
n=7 Participants
|
—
|
717 cells/µL
n=4 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: No participants enrolled in the Untreated Arm
Outcome measures
| Measure |
Stribild Arm
n=9 Participants
Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
Genvoya Arm
n=5 Participants
Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.
Genvoya: To be administered orally, once daily with food.
|
Untreated Arm
Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
|---|---|---|---|
|
Concentration of Elvitegravir in Cerebrospinal Fluid at Baseline
|
4.3 ng/mL
Interval 3.11 to 5.2
|
2.72 ng/mL
Interval 1.75 to 3.48
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: No participants enrolled in the Untreated Arm
Outcome measures
| Measure |
Stribild Arm
n=9 Participants
Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
Genvoya Arm
n=5 Participants
Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.
Genvoya: To be administered orally, once daily with food.
|
Untreated Arm
Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
|---|---|---|---|
|
Concentration of Elvitegravir in Cerebrospinal Fluid at Week 24
|
5.90 ng/mL
Interval 4.44 to 6.6
|
3.09 ng/mL
Interval 3.02 to 3.62
|
—
|
PRIMARY outcome
Timeframe: BaselinePopulation: No participants enrolled in the Untreated Arm
Outcome measures
| Measure |
Stribild Arm
n=9 Participants
Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
Genvoya Arm
n=5 Participants
Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.
Genvoya: To be administered orally, once daily with food.
|
Untreated Arm
Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
|---|---|---|---|
|
Concentration of Tenofovir in Cerebrospinal Fluid at Baseline
|
3.03 ng/mL
Interval 2.13 to 4.84
|
0.49 ng/mL
Interval 0.35 to 0.67
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: No participants enrolled in the Untreated Arm
Outcome measures
| Measure |
Stribild Arm
n=9 Participants
Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
Genvoya Arm
n=5 Participants
Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.
Genvoya: To be administered orally, once daily with food.
|
Untreated Arm
Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
|---|---|---|---|
|
Concentration of Tenofovir in Cerebrospinal Fluid at Week 24
|
0.507 ng/mL
Interval 0.344 to 1.197
|
0.481 ng/mL
Interval 0.255 to 0.556
|
—
|
Adverse Events
Stribild Arm
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Genvoya Arm
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Untreated Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stribild Arm
n=9 participants at risk
Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
Genvoya Arm
n=5 participants at risk
Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.
Genvoya: To be administered orally, once daily with food.
|
Untreated Arm
Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
|---|---|---|---|
|
Nervous system disorders
Headache, Grade 3
|
0.00%
0/9 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
20.0%
1/5 • Number of events 1 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
—
0/0 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
|
Renal and urinary disorders
Creatinine Clearance Reduction, Grade 3
|
11.1%
1/9 • Number of events 2 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
0.00%
0/5 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
—
0/0 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
Other adverse events
| Measure |
Stribild Arm
n=9 participants at risk
Stribild Arm is for participants taking Stribild at the time of study entry. Participants taking Stribild at the time of study entry will switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
Genvoya Arm
n=5 participants at risk
Genvoya Arm is for participants already taking Genvoya at the time of study entry. Participants taking Genvoya at the time of study entry will continue Genvoya for the second PK.
Genvoya: To be administered orally, once daily with food.
|
Untreated Arm
Untreated Arm is for participants who are not taking ART at the time of study entry. Participants will start Stribild at entry and switch to Genvoya before the second PK.
Stribild: To be administered orally, once daily with food.
Genvoya: To be administered orally, once daily with food.
|
|---|---|---|---|
|
Hepatobiliary disorders
Elevated Hepatic Alanine Transaminase, Grade 1
|
11.1%
1/9 • Number of events 2 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
20.0%
1/5 • Number of events 1 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
—
0/0 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
|
Endocrine disorders
Elevated Serum Glucose, Grade 1
|
11.1%
1/9 • Number of events 2 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
20.0%
1/5 • Number of events 1 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
—
0/0 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
|
Musculoskeletal and connective tissue disorders
Elevated Lactic Acid, Grade 1
|
11.1%
1/9 • Number of events 1 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
20.0%
1/5 • Number of events 1 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
—
0/0 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
|
Blood and lymphatic system disorders
Leukopenia, Grade 1
|
0.00%
0/9 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
20.0%
1/5 • Number of events 1 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
—
0/0 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
|
Renal and urinary disorders
Elevated Serum Bicarbonate, Grade 1
|
0.00%
0/9 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
20.0%
1/5 • Number of events 2 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
—
0/0 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
|
Musculoskeletal and connective tissue disorders
Elevated Creatine Kinase, Grade 2
|
0.00%
0/9 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
20.0%
1/5 • Number of events 1 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
—
0/0 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
|
Renal and urinary disorders
Elevated Serum Creatinine, Grade 1 or 2
|
11.1%
1/9 • Number of events 3 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
20.0%
1/5 • Number of events 1 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
—
0/0 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
|
Renal and urinary disorders
Hypernatremia, Grade 2
|
11.1%
1/9 • Number of events 1 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
0.00%
0/5 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
—
0/0 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
|
Hepatobiliary disorders
Elevated Hepatic Aspartate Transaminase, Grade 2
|
11.1%
1/9 • Number of events 1 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
0.00%
0/5 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
—
0/0 • 24 weeks
No participants enrolled in the Untreated Arm so the number of participants at risk is zero
|
Additional Information
Scott Letendre, Principal Investigator
University of California, San Diego
Phone: 6195438080
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place