Trial Outcomes & Findings for Genetics and HIV-1 Protease Inhibitors (NCT NCT01388543)
NCT ID: NCT01388543
Last Updated: 2019-11-19
Results Overview
Measure atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
31 participants
Primary outcome timeframe
Day 7
Results posted on
2019-11-19
Participant Flow
Participant milestones
| Measure |
CYP3A5 Expressors
A pre-screening genetic test determines CYP3A5 expressor status
Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
|
CYP3A5 Non-expressors
A pre-screening genetic test determines CYP3A5 non-expressor status
Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
|
|---|---|---|
|
Day 7, Primary End Point
STARTED
|
15
|
16
|
|
Day 7, Primary End Point
COMPLETED
|
15
|
16
|
|
Day 7, Primary End Point
NOT COMPLETED
|
0
|
0
|
|
Day 14
STARTED
|
15
|
16
|
|
Day 14
COMPLETED
|
14
|
12
|
|
Day 14
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
CYP3A5 Expressors
A pre-screening genetic test determines CYP3A5 expressor status
Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
|
CYP3A5 Non-expressors
A pre-screening genetic test determines CYP3A5 non-expressor status
Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
|
|---|---|---|
|
Day 14
Adverse Event
|
1
|
4
|
Baseline Characteristics
Genetics and HIV-1 Protease Inhibitors
Baseline characteristics by cohort
| Measure |
CYP3A5 Expressors
n=15 Participants
A pre-screening genetic test determines CYP3A5 expressor status
Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
|
CYP3A5 Non-expressors
n=16 Participants
A pre-screening genetic test determines CYP3A5 non-expressor status
Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7Measure atazanavir oral clearance in genetically-determined CYP3A5 expressors versus CYP3A5 non-expressors
Outcome measures
| Measure |
CYP3A5 Expressors
n=15 Participants
A pre-screening genetic test determines CYP3A5 expressor status
Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
|
CYP3A5 Non-expressors
n=16 Participants
A pre-screening genetic test determines CYP3A5 non-expressor status
Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
|
|---|---|---|
|
Day 7 Atazanavir Oral Clearance
|
.25 L/h/kg
Interval 0.2 to 0.3
|
.18 L/h/kg
Interval 0.15 to 0.22
|
Adverse Events
CYP3A5 Expressor
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
CYP3A5 Non-expressors
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CYP3A5 Expressor
n=15 participants at risk
A pre-screening genetic test determines CYP3A5 expressor status
Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
|
CYP3A5 Non-expressors
n=16 participants at risk
A pre-screening genetic test determines CYP3A5 expressor status
Atazanavir: Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Time of consenting to study exit (Day 14 or earlier)
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0 Aug 2009 (US Dept HHS, NIH, NIAID) Available from: http://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
|
0.00%
0/16 • Time of consenting to study exit (Day 14 or earlier)
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0 Aug 2009 (US Dept HHS, NIH, NIAID) Available from: http://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
|
|
Hepatobiliary disorders
Abnormal Lab- albumin
|
0.00%
0/15 • Time of consenting to study exit (Day 14 or earlier)
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0 Aug 2009 (US Dept HHS, NIH, NIAID) Available from: http://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
|
6.2%
1/16 • Time of consenting to study exit (Day 14 or earlier)
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0 Aug 2009 (US Dept HHS, NIH, NIAID) Available from: http://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
|
|
General disorders
Unspecified viral syndrome-not study related
|
0.00%
0/15 • Time of consenting to study exit (Day 14 or earlier)
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0 Aug 2009 (US Dept HHS, NIH, NIAID) Available from: http://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
|
6.2%
1/16 • Time of consenting to study exit (Day 14 or earlier)
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0 Aug 2009 (US Dept HHS, NIH, NIAID) Available from: http://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
|
|
Hepatobiliary disorders
Abnormal Lab- Aspartate transaminase (AST)
|
0.00%
0/15 • Time of consenting to study exit (Day 14 or earlier)
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0 Aug 2009 (US Dept HHS, NIH, NIAID) Available from: http://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
|
6.2%
1/16 • Time of consenting to study exit (Day 14 or earlier)
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0 Aug 2009 (US Dept HHS, NIH, NIAID) Available from: http://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
|
|
Endocrine disorders
Abnormal Lab- Amylase
|
0.00%
0/15 • Time of consenting to study exit (Day 14 or earlier)
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0 Aug 2009 (US Dept HHS, NIH, NIAID) Available from: http://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
|
6.2%
1/16 • Time of consenting to study exit (Day 14 or earlier)
AEs were graded per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V1.0 Aug 2009 (US Dept HHS, NIH, NIAID) Available from: http://rsc.tech-res.com/docs/default-source/safety/table\_for\_grading\_severity\_of\_adult\_pediatric\_adverse\_events.pdf
|
Additional Information
Dr. Peter Anderson
University of Colorado | Skaggs School of Pharmacy and Pharmaceutical Sciences
Phone: 3037246128
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place