Raltegravir Therapy for Women With HIV and Fat Accumulation

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00656175
First received: April 2, 2008
Last updated: December 17, 2012
Last verified: December 2012
Results First Received: June 12, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: HIV Infections
Lipodystrophy
Intervention: Drug: raltegravir

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Immediate Immediate switch of PI or NNRTI to Raltegravir (400 mg twice daily)
Delayed Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir (400mg twice daily)

Participant Flow:   Overall Study
    Immediate     Delayed  
STARTED     18     21  
COMPLETED     17     20  
NOT COMPLETED     1     1  
Adverse Event                 1                 0  
Transportation issues                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Immediate Immediate switch of PI or NNRTI to Raltegravir
Delayed Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir
Total Total of all reporting groups

Baseline Measures
    Immediate     Delayed     Total  
Number of Participants  
[units: participants]
  18     21     39  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     18     21     39  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  39  ± 47     36  ± 51     37  ± 49  
Gender  
[units: participants]
     
Female     18     21     39  
Male     0     0     0  
Race/Ethnicity, Customized [1]
[units: Participants]
     
African-American     9     13     22  
Hispanic     5     3     8  
White     3     5     8  
Asian     1     0     1  
Region of Enrollment [2]
[units: Participants]
     
North America     18     21     39  
[1] 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.
[2] Subjects were recruited from 5 centers in North America between September 2008 and July 2010.



  Outcome Measures

1.  Primary:   Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2)   [ Time Frame: Baseline and 24 weeks ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Immediate Immediate switch of PI or NNRTI to Raltegravir
Delayed Continue current therapy unchanged for 24 weeks then switch PI or NNRTI to Raltegravir

Other Adverse Events
    Immediate     Delayed  
Total, other (not including serious) adverse events      
# participants affected / at risk     0/17     0/20  



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: jlake@mednet.ucla.edu


Publications of Results:

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
Study First Received: April 2, 2008
Results First Received: June 12, 2012
Last Updated: December 17, 2012
Health Authority: United States: Institutional Review Board