Trial Outcomes & Findings for "The Once A Day Protease Inhibitor Regimens" (NCT NCT00242216)

NCT ID: NCT00242216

Last Updated: 2014-01-15

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 76 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2014-01-15

Participant Flow

Patients enrolled at a county clinic

Participant milestones

Measure	Atazanavir Atazanavir/ritonavir (300mg/100mg) once daily	Fosamprenavir Fosamprenavir/ritonavir (1400mg/100mg) once daily
Overall Study STARTED	39	37
Overall Study COMPLETED	21	15
Overall Study NOT COMPLETED	18	22

Reasons for withdrawal

Measure	Atazanavir Atazanavir/ritonavir (300mg/100mg) once daily	Fosamprenavir Fosamprenavir/ritonavir (1400mg/100mg) once daily
Overall Study Lost to Follow-up	12	17
Overall Study Death	4	2
Overall Study Lack of Efficacy	1	2
Overall Study no medicaiton dispensed	1	1

Baseline Characteristics

"The Once A Day Protease Inhibitor Regimens"

Baseline characteristics by cohort

Measure	Atazanavir n=39 Participants	Fosamprenavir n=37 Participants	Total n=76 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	38 Participants n=5 Participants	33 Participants n=7 Participants	71 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Age, Continuous	48 years STANDARD_DEVIATION 9.7 • n=5 Participants	48 years STANDARD_DEVIATION 10 • n=7 Participants	48 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants	37 participants n=7 Participants	76 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Outcome measures

Measure	Atazanavir n=18 Participants	Fosamprenavir n=15 Participants
Proportion of Patient With Viral Load Less Than 400 Copies/mL	89 percentage	73 percentage

SECONDARY outcome

Timeframe: 24 weeks.

Outcome measures

Measure	Atazanavir n=18 Participants	Fosamprenavir n=15 Participants
CD4 Cell Count Change From Baseline During Treatment.	139 cell/mm3 Standard Deviation 119	117 cell/mm3 Standard Deviation 99

Adverse Events

Atazanavir

Serious events: 9 serious events

Other events: 9 other events

Deaths: 0 deaths

Fosamprenavir

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Atazanavir n=39 participants at risk	Fosamprenavir n=37 participants at risk
Gastrointestinal disorders Left perineal abscess	2.6% 1/39 • Number of events 1	— 0/0
Blood and lymphatic system disorders Anemia	0.00% 0/39	2.7% 1/37 • Number of events 2
General disorders death	7.7% 3/39 • Number of events 3	5.4% 2/37 • Number of events 2
Skin and subcutaneous tissue disorders Steven's Johnson Syndrome	2.6% 1/39 • Number of events 1	0.00% 0/37
Respiratory, thoracic and mediastinal disorders Pneumonia	2.6% 1/39 • Number of events 1	2.7% 1/37 • Number of events 1
Infections and infestations Cryptococal meningitis	0.00% 0/39	2.7% 1/37 • Number of events 1
Reproductive system and breast disorders Rupture hemorrhagic cyst	0.00% 0/39	2.7% 1/37 • Number of events 1
Nervous system disorders Seizure Disorder	2.6% 1/39 • Number of events 5	0.00% 0/37
Nervous system disorders Intracraneal Hypertension	2.6% 1/39 • Number of events 1	0.00% 0/37
Gastrointestinal disorders Abdominal Pain	2.6% 1/39 • Number of events 1	0.00% 0/37

Other adverse events

Measure	Atazanavir n=39 participants at risk	Fosamprenavir n=37 participants at risk
Gastrointestinal disorders hyperbilirrubinemia	17.9% 7/39 • Number of events 7	0.00% 0/37
Hepatobiliary disorders Increased LFTs	5.1% 2/39 • Number of events 2	0.00% 0/37

Additional Information

Dr. Roberto C. Arduino, Professor of Medicine

The University of Texas Health Science Center at Houston

Phone: 713-500-6731

Email: roberto.c.arduino@uth.tmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place