Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Hide Participant Flow

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


  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


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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