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Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients (LIPOKAL)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978237
First Posted: September 16, 2009
Last Update Posted: September 18, 2014
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.
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
September 15, 2009
September 16, 2009
September 18, 2014
October 2009
November 2013   (Final data collection date for primary outcome measure)
Absolute change in limb fat mass measured by DEXA. [ Time Frame: 24 months. ]
Same as current
Complete list of historical versions of study NCT00978237 on ClinicalTrials.gov Archive Site
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Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients
CT to Assess the Effect on the Subcutaneous Fat of Change of EFV for LPV/r in HIV-infected Patients Who Developed Lipoatrophy and Remains Despite Treatment With Efavirenz and Fixed-dose Combination of no Thymidine Nucleoside Analogues.
Eligible HIV-infected patients with clinically evident lipoatrophy despite treatment with efavirenz and fixed-dose combination of thymidine nucleoside analogues will be informed and asked to enroll in the study; will be randomized (1:1) into two branches, A: EFV + Fixed combinations of analogue tenofovir + emtricitabine.B (experimental): LPV/r + combination of correspondent analogues. The main variable is the evaluation of the absolute change in limb fat mass at 24 months from baseline in both groups.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • HIV Infections
  • Lipoatrophy
  • Drug: EFV
    one pill QD VO.
  • Drug: LPV/r
    2 pills QD VO
  • Active Comparator: EFV and Fixed combinations of analogues
    EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine
    Intervention: Drug: EFV
  • Experimental: LPV/r and combination of analogues.
    Intervention: Drug: LPV/r
Rojas J, Lonca M, Imaz A, Estrada V, Asensi V, Miralles C, Domingo P, Montero M, del Rio L, Fontdevila J, Perez I, Cruceta A, Gatell JM, Arnedo M, Martínez E. Improvement of lipoatrophy by switching from efavirenz to lopinavir/ritonavir. HIV Med. 2016 May;17(5):340-9. doi: 10.1111/hiv.12314. Epub 2015 Sep 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
November 2013
November 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients HIV positive > 18 years.
  • Patients in treatment with Sustiva(r)+Truvada(r); or Sustiva (r)+Kivexa(r).
  • HIV-ARN < 50 copies/mL in the las six months.
  • Clinically evident lipoatrophy (moderate or severe).
  • Negative pregnancy test.
  • Signed informed consent.

Exclusion Criteria:

  • Evidence of failure or mutation to therapy with protease inhibitors.
  • Patients that can not be treated with LPV/r.
  • Mild lipoatrophy.
  • History of alcoholism or drug addiction that discourages participation in the study.
  • Pregnancy or breastfeeding.
  • Documented current or 4 weeks prior opportunistic infection.
  • Creatinin clearance < 60mL/min.
  • Concomitant use of nephrotoxic drugs or immunosuppressants.
  • Actual treatment with systemic corticosteroids, IL-2 or chemotherapy.
  • Patients under treatment with other drugs in investigation.
  • Acute hepatitis.
  • Any other disease that discourages participation.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT00978237
LIPOKAL
No
Not Provided
Not Provided
Juan A. Arnaiz, Hospital Clinic of Barcelona
Juan A. Arnaiz
Not Provided
Not Provided
Hospital Clinic of Barcelona
September 2014

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