Trial Outcomes & Findings for Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects (NCT NCT01010399)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

24 weeks

Results posted on

2012-04-18

Withdrawal data not reported

Boosted Lexiva With Lovaza Adjunctive Therapy in Hypertriglyceridemic, HIV-Infected Subjects

Baseline characteristics by cohort
Measure	Boosted Lexiva With Lovaza n=36 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	36 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age Continuous	48.3 years STANDARD_DEVIATION 6.9 • n=99 Participants
Sex: Female, Male Female	1 Participants n=99 Participants
Sex: Female, Male Male	35 Participants n=99 Participants
Region of Enrollment United States	36 participants n=99 Participants

Timeframe: 24 weeks

Outcome measures
Measure	Boosted Lexiva With Lovaza n=36 Participants
Proportion of Subjects With Triglycerides <200 mg/dL	12 participants

Timeframe: 24 weeks

Outcome measures
Measure	Boosted Lexiva With Lovaza n=36 Participants
Proportion of Subjects With HIV-1 RNA <50 Copies/mL	28 participants

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Boosted Lexiva With Lovaza n=36 participants at risk
Metabolism and nutrition disorders hypercholesterolemia	11.1% 4/36 • Number of events 4
Gastrointestinal disorders diarrhea	2.8% 1/36 • Number of events 1
Infections and infestations influenza	2.8% 1/36 • Number of events 1

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