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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

April 2, 2008
December 17, 2012
September 2008
December 2011   (final data collection date for primary outcome measure)
Baseline to 24-week Change in Visceral Adipose Tissue Volume (cm^2) [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
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.
Compared to continued treatment with a PI and/or NNRTI based regimen, substituting raltegravir will be associated with a 10% reduction in visceral adipose tissue over 24 weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00656175 on ClinicalTrials.gov Archive Site
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Raltegravir Therapy for Women With HIV and Fat Accumulation
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Lipodystrophy
Drug: raltegravir
raltegravir
Other Name: Isentress
  • Active Comparator: Immediate
    Immediate switch of PI or NNRTI to Raltegravir
    Intervention: Drug: raltegravir
  • Active Comparator: Delayed
    Continue current therapy unchanged for 24 weeks, then switch PI or NNRTI to Raltegravir
    Intervention: Drug: raltegravir
Lake JE, McComsey GA, Hulgan TM, Wanke CA, Mangili A, Walmsley SL, Boger MS, Turner RR, McCreath HE, Currier JS. A randomized trial of Raltegravir replacement for protease inhibitor or non-nucleoside reverse transcriptase inhibitor in HIV-infected women with lipohypertrophy. AIDS Patient Care STDS. 2012 Sep;26(9):532-40. doi: 10.1089/apc.2012.0135. Epub 2012 Jul 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00656175
IISP-Raltegravir
No
Judith S. Currier, University of California, Los Angeles
University of California, Los Angeles
  • Merck Sharp & Dohme Corp.
  • Case Western Reserve University
  • Vanderbilt University
  • Tufts University
  • University Health Network, Toronto
Principal Investigator: Judith S. Currier, M.D. University of California, Los Angeles
Study Chair: Grace McComsey, M.D. Case School of Medicine
University of California, Los Angeles
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP