Trial Outcomes & Findings for Kaletra-isentress Treatment Evaluation (NCT NCT00700115)

NCT ID: NCT00700115

Last Updated: 2014-12-12

Results Overview

Percentage subjects with undetectable Plasma viral loads

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 60 participants
• Primary outcome timeframe: baseline to week 48
• Results posted on: 2014-12-12

Participant Flow

All subjects were recruited from an urban outpatient HIV clinic (the Grady Infectious Diseases Program Out-patient Clinic, Atlanta, Georgia) between June 2008 and January 2011.

Subjects were excluded if they were on medications that could interact with Protease inhibitors, had an active opportunistic infection, had renal and/or hepatic impairment, or were pregnant. Hepatitis B virus (HBV) co-infected patients receiving a nucleotide analogue for both HIV and HBV suppression were also excluded from enrollment.

Participant milestones

Measure	Kaletra + Isentress Switched to Kaletra + Isentress	Standard HAART Pre-study standard HAART regimen
Overall Study STARTED	40	20
Overall Study COMPLETED	39	19
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Kaletra + Isentress Switched to Kaletra + Isentress	Standard HAART Pre-study standard HAART regimen
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Kaletra-isentress Treatment Evaluation

Baseline characteristics by cohort

Measure	Kaletra + Isentress n=40 Participants switched to Kaletra + Isentress	Standard HAART n=20 Participants Pre-study standard HAART regimen	Total n=60 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	40 Participants n=5 Participants	20 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	46 years STANDARD_DEVIATION 9 • n=5 Participants	48 years STANDARD_DEVIATION 12 • n=7 Participants	47 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	12 Participants n=7 Participants	38 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	20 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to week 48

Percentage subjects with undetectable Plasma viral loads

Outcome measures

Measure	Kaletra + Isentress n=40 Participants switched to Kaletra + Isentress	Standard HAART n=20 Participants Pre-study standard HAART regimen
Plasma Viral Loads (HIV-1 RNA PCR)	92.7 percentage of subjects Interval 83.0 to 100.0	88 percentage of subjects Interval 75.0 to 100.0

SECONDARY outcome

Timeframe: 48 weeks

Population: intention to treat

Outcome measures

Measure	Kaletra + Isentress n=35 Participants switched to Kaletra + Isentress	Standard HAART n=19 Participants Pre-study standard HAART regimen
To Compare Plasma Triglyceride Levels at 48 Weeks Between LPV/r + RAL and Standard HAART Treated Subjects	238.1 mg/dL Standard Error 19.9	133.3 mg/dL Standard Error 27.1

Adverse Events

Kaletra + Isentress

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard HAART

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Igho Ofotokun

Emory University School of Medicine

Phone: 404-616-0659

Email: iofotok@emory.edu

Results disclosure agreements

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