ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00887653
Recruitment Status : Completed
First Posted : April 24, 2009
Results First Posted : October 10, 2014
Last Update Posted : October 10, 2014
Sponsor:
Collaborators:
Tufts Medical Center
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Aadia Rana, The Miriam Hospital

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV
Hyperlipidemia
Hypertriglyceridemia
HIV Infections
Intervention Drug: raltegravir
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Raltegravir Arm
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Raltegravir Arm
Hide Arm/Group Description

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 Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 20 participants
52
(40 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
3
  15.0%
Male
17
  85.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  10.0%
White
16
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
  10.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Change From Baseline Triglycerides
Hide Description Assess changes from baseline triglycerides at 3 months
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: units on a scale
125
(93 to 224)
2.Primary Outcome
Title Change From Baseline Triglycerides
Hide Description Assess changes from baseline triglycerides at 6 months
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raltegravir Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Median (Full Range)
Unit of Measure: units on a scale
120
(93.3 to 170.3)
3.Secondary Outcome
Title Proportion of Patients With Plasma Viral Load Below the Limit of Detection
Hide Description Assess proportion of patients with PVL below limit of detection at end of study.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Raltegravir Arm
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: proportion of participants
0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Raltegravir Arm
Hide Arm/Group Description

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.

All-Cause Mortality
Raltegravir Arm
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Raltegravir Arm
Affected / at Risk (%) # Events
Total   1/20 (5.00%)    
Immune system disorders   
Virologic Failure  [1]  1/20 (5.00%)  1
Indicates events were collected by systematic assessment
[1]
One subject was found at week 12 with HIV-1 RNA of 57 copies/mL; repeat with 61 copies. Genotype revealed no evidence of resistance. The subject was then initiated on darunavir/ritonavir regimen with subsequent re-suppression to <50 copies/mL.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Raltegravir Arm
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Aadia Rana
Organization: THE MIRIAM HOSPITAL
Phone: 4017934680
Responsible Party: Aadia Rana, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00887653     History of Changes
Other Study ID Numbers: 2007-09
First Submitted: April 23, 2009
First Posted: April 24, 2009
Results First Submitted: September 19, 2014
Results First Posted: October 10, 2014
Last Update Posted: October 10, 2014