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Raltegravir Therapy for Women With HIV and Fat Accumulation

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ClinicalTrials.gov 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 LLC
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

Brief Summary:

Ritonavir-boosted protease inhibitor (PI) regimens have become a backbone for treatment of people with HIV. However, adverse drug effects, particularly lipodystrophy/lipoatrophy are closely associated with these regimens. Therefore, there is a need for a drug with comparable effectiveness to the ritonavir boosted PIs without the side effects of dyslipidemia, which has been associated with elevated cholesterol and cardiovascular disease

Raltegravir is an HIV integrase inhibitor in phase III clinical development. To date there are no approved drugs that target the same stage of the HIV-1 lifecycle. However, data from studies indicate that raltegravir is generally safe and well tolerated and has strong antiretroviral activity when used in combination with licensed antiretroviral medications.

This study aims to demonstrate that patients substituting raltegravir for a PI or NNRTI based antiretroviral regimen will be associated with a 10% reduction in body fat over 24 weeks.

The study will consist of a total of 10 subject visits over a period of 48 weeks. Approximately 40 female patients will participate in this study (approximately 10 at UCLA).

Condition or disease Intervention/treatment Phase
HIV Infections Lipodystrophy Drug: raltegravir Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Raltegravir as Replacement for Protease Inhibitor or Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) Based Antiretroviral Therapy in Women With Fat Accumulation
Study Start Date : September 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Immediate
Immediate switch of PI or NNRTI to Raltegravir
Drug: raltegravir
Other Name: Isentress

Active Comparator: Delayed
Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir
Drug: raltegravir
Other Name: Isentress

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry or plasma HIV-1 RNA > 2000 on two occasions,
  • Female subjects 18 years or older
  • Documented central fat accumulation (defined by waist circumference of > 94 cm or a waist to hip ratio of > 0.88).
  • Documented HIV RNA <50 copies/mL at screening and <400 copies/mL in the past 6 months.
  • Current antiretroviral therapy with two nucleoside analogues and either a non-nucleoside analogue (nevirapine, efavirenz or TMC125) or an approved protease inhibitor. Patients on NNRTI+PI at study entry will be excluded. Study participants do not need to be on their first regimen. No changes in ART in the 12 weeks prior to screening. The nucleoside backbone must include either tenofovir or abacavir and either lamivudine or emtricitabine. Fixed dose combinations with emtricitabine or abacavir are allowed.
  • For females of reproductive potential (women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or women who have not undergone surgical sterilization, specifically hysterectomy, or bilateral oophorectomy and/or tubal ligation), will need a negative serum or urine pregnancy test within 48 hours prior to entry.
  • Ability and willingness of subject to provide informed consent.

Exclusion Criteria:

  • Pregnancy: current or within the past 6 months or breast feeding
  • Prior treatment history that would preclude the use of emtricitabine or abacavir as the nucleoside backbone during study treatment
  • Current use of metformin or thiazolidinediones.
  • Use of growth hormone or growth hormone releasing factor in the last 6 months before screening.
  • Change or initiation of anti-hyperlipemic regimen within 3 months prior to randomization; Use of stable anti-hyperlipemic regimen during the study is allowed.
  • Current use of androgen therapy.
  • Intent to modify diet, exercise habits or to enroll in a weight loss intervention during the study period.
  • Current or projected need to use rifampin, dilantin or phenobarbital during the 48-week study period.
  • Laboratory values at screening of

    • ANC >500 cells/mm3
    • Hemoglobin <10 gm/dl
    • CrCl > 60 ml/min (estimated by Cockcroft-Gault equation)
    • AST or ALT > 3 x ULN

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656175

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United States, California
Los Angeles, California, United States, 90035
United States, Massachusetts
Tufts University School of Medicine
Boston, Massachusetts, United States, 02111
United States, Ohio
Case School of Medicine
Cleveland, Ohio, United States, 44106
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37203
Canada, Ontario
University Health Network, Toronto
Toronto, Ontario, Canada
Sponsors and Collaborators
University of California, Los Angeles
Merck Sharp & Dohme LLC
Case Western Reserve University
Vanderbilt University
Tufts University
University Health Network, Toronto
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Principal Investigator: Judith S. Currier, M.D. University of California, Los Angeles
Study Chair: Grace McComsey, M.D. Case School of Medicine
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Judith S. Currier, M.D., University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00656175    
Obsolete Identifiers: NCT00755612
Other Study ID Numbers: IISP-Raltegravir
First Posted: April 10, 2008    Key Record Dates
Results First Posted: December 19, 2012
Last Update Posted: December 19, 2012
Last Verified: December 2012
Keywords provided by Judith S. Currier, University of California, Los Angeles:
visceral fat
anti HIV therapy
Protease inhibitor
integrase inhibitor
treatment experienced
Additional relevant MeSH terms:
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Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Raltegravir Potassium
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action