Trial Outcomes & Findings for Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy (NCT NCT00887653)

NCT ID: NCT00887653

Last Updated: 2014-10-10

Results Overview

Assess changes from baseline triglycerides at 3 months

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 20 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2014-10-10

Participant Flow

Participant milestones

Measure	Raltegravir Arm This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Changes in Lipids and Safety of Raltegravir in HIV+ Patients With Hyperlipidemia While on Current Standard Therapy

Baseline characteristics by cohort

Measure	Raltegravir Arm n=20 Participants This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	2 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Assess changes from baseline triglycerides at 3 months

Outcome measures

Measure	Raltegravir Arm n=20 Participants This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.
Change From Baseline Triglycerides	125 units on a scale Interval 93.0 to 224.0

PRIMARY outcome

Timeframe: 6 months

Assess changes from baseline triglycerides at 6 months

Outcome measures

Measure	Raltegravir Arm n=20 Participants This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.
Change From Baseline Triglycerides	120 units on a scale Interval 93.3 to 170.3

SECONDARY outcome

Timeframe: 6 months

Population: One subject was prematurely discontinued from the study at week 12 due to detectable HIV-1 RNA of 57 copies/mL that was sustained at 61 copies on repeated measurement two weeks later.

Assess proportion of patients with PVL below limit of detection at end of study.

Outcome measures

Measure	Raltegravir Arm n=20 Participants This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.
Proportion of Patients With Plasma Viral Load Below the Limit of Detection	0 proportion of participants

Adverse Events

Raltegravir Arm

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Raltegravir Arm n=20 participants at risk This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily.
Immune system disorders Virologic Failure	5.0% 1/20 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Aadia Rana

THE MIRIAM HOSPITAL

Phone: 4017934680

Email: arana@lifespan.org

Results disclosure agreements

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