ClinicalTrials.gov
ClinicalTrials.gov Menu

Raltegravir Therapy for Women With HIV and Fat Accumulation

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: NCT00656175
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : December 19, 2012
Last Update Posted : December 19, 2012
Sponsor:
Collaborators:
Merck Sharp & Dohme Corp.
Case Western Reserve University
Vanderbilt University
Tufts University
University Health Network, Toronto
Information provided by (Responsible Party):
Judith S. Currier, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions HIV Infections
Lipodystrophy
Intervention Drug: raltegravir
Enrollment 39
Recruitment Details

61 subjects were screened, 39 enrolled, and 37 completed the Week 24 primary endpoint at 5 sites in North America.

Of the 37 subjects included in the as-treated analysis, 17 were randomized to immediate-switch (Immediate Group), and 20 to delayed-switch (Delayed Group).

Pre-assignment Details  
Arm/Group Title Immediate Delayed
Hide Arm/Group Description Immediate switch of PI or NNRTI to Raltegravir (400 mg twice daily) Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir (400mg twice daily)
Period Title: Overall Study
Started 18 21
Completed 17 20
Not Completed 1 1
Reason Not Completed
Adverse Event             1             0
Transportation issues             0             1
Arm/Group Title Immediate Delayed Total
Hide Arm/Group Description Immediate switch of PI or NNRTI to Raltegravir Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir Total of all reporting groups
Overall Number of Baseline Participants 18 21 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 21 participants 39 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
 100.0%
21
 100.0%
39
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 21 participants 39 participants
39  (47) 36  (51) 37  (49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 21 participants 39 participants
Female
18
 100.0%
21
 100.0%
39
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants 21 participants 39 participants
African-American 9 13 22
Hispanic 5 3 8
White 3 5 8
Asian 1 0 1
[1]
Measure Description: Subjects were recruited from 5 centers in North America between September 2008 and July 2010. Age 18 or older, documented HIV-1 infection, central fat accumulation at screening and <400 copies/mL for the 6 months prior to entry, current ART with a nucleoside (NRTI) backbone of tenofovir or abacavir AND emtricitabine or lamivudine PLUS either a PI or NNRTI, no change in ART for 12 weeks prior to screening, and ability and willingness to provide informed consent.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
North America Number Analyzed 18 participants 21 participants 39 participants
18 21 39
[1]
Measure Description: Subjects were recruited from 5 centers in North America between September 2008 and July 2010.
1.Primary Outcome
Title Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2)
Hide Description Adipose tissue volumes were measured via single slice L4-L5 CT scan, and volumes were calculated using cm^2, not cm^3, as is standard protocol at the Tufts University Body Composition Reading Center. The authors acknowledge that cm^2 uses area as a surrogate for volume, but this protocol is well-accepted in our field.
Time Frame Baseline and 24 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Immediate Delayed
Hide Arm/Group Description:
Immediate switch of PI or NNRTI to Raltegravir
Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir
Overall Number of Participants Analyzed 17 20
Median (Inter-Quartile Range)
Unit of Measure: cm^2
-6.6
(-15.5 to 17.6)
1.8
(-9.3 to 8.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Immediate, Delayed
Comments Wilcoxon sign-rank test used for statistical significance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immediate Delayed
Hide Arm/Group Description Immediate switch of PI or NNRTI to Raltegravir Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
All-Cause Mortality
Immediate Delayed
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Immediate Delayed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Immediate Delayed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/20 (0.00%) 
High prevalence of generalized obesity; small sample size; short follow-up; not designed to assess the potential contribution of NRTIs to lipohypertrophy, nor could we exclude the NRTI backbone as a confounding factor.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jordan Lake
Organization: UCLA CARE Center
Phone: 310-557-9679
Responsible Party: Judith S. Currier, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00656175     History of Changes
Obsolete Identifiers: NCT00755612
Other Study ID Numbers: IISP-Raltegravir
First Submitted: April 2, 2008
First Posted: April 10, 2008
Results First Submitted: June 12, 2012
Results First Posted: December 19, 2012
Last Update Posted: December 19, 2012