Trial Outcomes & Findings for Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens (NCT NCT00940771)
NCT ID: NCT00940771
Last Updated: 2020-04-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
4 Weeks, 12 weeks, 24 weeks
Results posted on
2020-04-20
Participant Flow
Pediatric patients with elevated cholesterol were recruited from a Pediatric HIV Clinic between April 8, 2009 and May 1, 2013.
Participant milestones
| Measure |
Boosted Atazanavir
Boosted atazanavir was switched for the PI or NNRTI in the patients regimen
Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.
|
|---|---|
|
Pre-Entry
STARTED
|
10
|
|
Pre-Entry
COMPLETED
|
10
|
|
Pre-Entry
NOT COMPLETED
|
0
|
|
4 Weeks
STARTED
|
10
|
|
4 Weeks
COMPLETED
|
10
|
|
4 Weeks
NOT COMPLETED
|
0
|
|
12 Weeks
STARTED
|
10
|
|
12 Weeks
COMPLETED
|
10
|
|
12 Weeks
NOT COMPLETED
|
0
|
|
24 Weeks
STARTED
|
10
|
|
24 Weeks
COMPLETED
|
10
|
|
24 Weeks
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Equivalence of Boosted Atazanavir Based Regimens and Currently Effective HAART Regimens
Baseline characteristics by cohort
| Measure |
Boosted Atazanavir
n=10 Participants
Boosted atazanavir was switched for the PI or NNRTI in the patients regimen
Boosted Atazanavir: Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.
|
|---|---|
|
Age, Continuous
|
9.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
CD4
|
1233.1 cells/uL
STANDARD_DEVIATION 473.8 • n=5 Participants
|
|
Viral Load
|
2.3 copies/ml
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Cholesterol
|
214.3 mg/dL
STANDARD_DEVIATION 31.6 • n=5 Participants
|
|
Triglycerides
|
288.5 mg/dL
STANDARD_DEVIATION 253.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 4 Weeks, 12 weeks, 24 weeksOutcome measures
| Measure |
Boosted Atazanavir
n=10 Participants
Boosted atazanavir was switched for the PI or NNRTI in the patients regimen
Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.
|
|---|---|
|
Non-fasting Cholesterol
Week 4
|
187.2 mg/dL
Standard Deviation 30.0
|
|
Non-fasting Cholesterol
Week 12
|
178.5 mg/dL
Standard Deviation 38.1
|
|
Non-fasting Cholesterol
Week 24
|
181.5 mg/dL
Standard Deviation 29.3
|
PRIMARY outcome
Timeframe: 4 weeks, 12 weeks, 24 weeksOutcome measures
| Measure |
Boosted Atazanavir
n=10 Participants
Boosted atazanavir was switched for the PI or NNRTI in the patients regimen
Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.
|
|---|---|
|
Non-fasting Triglycerides
Week 4
|
240.5 mg/dL
Standard Deviation 107.2
|
|
Non-fasting Triglycerides
Week 12
|
195.5 mg/dL
Standard Deviation 93.8
|
|
Non-fasting Triglycerides
Week 24
|
193.3 mg/dL
Standard Deviation 106.5
|
SECONDARY outcome
Timeframe: 4 weeks, 12 weeks, 24 weeksPopulation: Number of patients with undetectable viral load
Number of participants with undetectable viral load
Outcome measures
| Measure |
Boosted Atazanavir
n=10 Participants
Boosted atazanavir was switched for the PI or NNRTI in the patients regimen
Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.
|
|---|---|
|
Viral Load
Week 4
|
10 Participants
|
|
Viral Load
Week 12
|
9 Participants
|
|
Viral Load
Week 24
|
9 Participants
|
SECONDARY outcome
Timeframe: 4 Weeks, 12 weeks, 24 weeksOutcome measures
| Measure |
Boosted Atazanavir
n=10 Participants
Boosted atazanavir was switched for the PI or NNRTI in the patients regimen
Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.
|
|---|---|
|
CD4 Count
Week 4
|
1214.3 cells/uL
Standard Deviation 476.8
|
|
CD4 Count
Week 12
|
1151.9 cells/uL
Standard Deviation 442.7
|
|
CD4 Count
Week 24
|
1120.0 cells/uL
Standard Deviation 413.2
|
Adverse Events
Boosted Atazanavir
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Boosted Atazanavir
n=10 participants at risk
Boosted atazanavir was switched for the PI or NNRTI in the patients regimen
Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.
|
|---|---|
|
Infections and infestations
Pansinusitis
|
10.0%
1/10 • Number of events 1 • 24 weeks
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events V 1.0, December 2004, Clarification August 2009 was used to grade labs and symptoms that were reported at week 4, week 12 and week 24 visits.
|
Other adverse events
| Measure |
Boosted Atazanavir
n=10 participants at risk
Boosted atazanavir was switched for the PI or NNRTI in the patients regimen
Boosted atazanavir, once a day dose adjusted for child's weight for 6 months.
|
|---|---|
|
Blood and lymphatic system disorders
Pain, neck and face
|
10.0%
1/10 • Number of events 1 • 24 weeks
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events V 1.0, December 2004, Clarification August 2009 was used to grade labs and symptoms that were reported at week 4, week 12 and week 24 visits.
|
|
General disorders
Fever
|
20.0%
2/10 • Number of events 2 • 24 weeks
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events V 1.0, December 2004, Clarification August 2009 was used to grade labs and symptoms that were reported at week 4, week 12 and week 24 visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pain, throat
|
10.0%
1/10 • Number of events 1 • 24 weeks
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events V 1.0, December 2004, Clarification August 2009 was used to grade labs and symptoms that were reported at week 4, week 12 and week 24 visits.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
10.0%
1/10 • Number of events 1 • 24 weeks
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events V 1.0, December 2004, Clarification August 2009 was used to grade labs and symptoms that were reported at week 4, week 12 and week 24 visits.
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10 • Number of events 1 • 24 weeks
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events V 1.0, December 2004, Clarification August 2009 was used to grade labs and symptoms that were reported at week 4, week 12 and week 24 visits.
|
|
Gastrointestinal disorders
Laboratory Abnormality
|
10.0%
1/10 • Number of events 3 • 24 weeks
The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events V 1.0, December 2004, Clarification August 2009 was used to grade labs and symptoms that were reported at week 4, week 12 and week 24 visits.
|
Additional Information
Janice Piatt, MD, Medical Director
Bill Holt Clinic, Phoenix Children's Hospital
Phone: 602-933-0955
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place