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. Identifier: NCT00656175
Recruitment Status : Completed
First Posted : April 10, 2008
Results First Posted : December 19, 2012
Last Update Posted : December 19, 2012
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
Intervention: Drug: raltegravir

  Participant Flow

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 18   21   39 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   18   21   39 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 39  (47)   36  (51)   37  (49) 
[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 
[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.
Region of Enrollment [1] 
[Units: Participants]
North America   18   21   39 
[1] 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

  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

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

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Judith S. Currier, University of California, Los Angeles 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