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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)

Primary Purpose

HIV Infections, Lipoatrophy

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
EFV
LPV/r
Sponsored by
Juan A. Arnaiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV - Lipoatrophy, treatment experienced

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital de Bellvitge
  • Hospital Universitario Central de Asturias
  • Hospital Clínic de Barcelona
  • Hospital de la Santa Creu i Sant Pau de Barcelona
  • Hospital Clínico San Carlos
  • Hospital La Fe
  • Hospital Xeral-Cíes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

EFV and Fixed combinations of analogues

LPV/r and combination of analogues.

Arm Description

EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine

Outcomes

Primary Outcome Measures

Absolute change in limb fat mass measured by DEXA.

Secondary Outcome Measures

Full Information

First Posted
September 15, 2009
Last Updated
September 17, 2014
Sponsor
Juan A. Arnaiz
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1. Study Identification

Unique Protocol Identification Number
NCT00978237
Brief Title
Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients
Acronym
LIPOKAL
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan A. Arnaiz

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Lipoatrophy
Keywords
HIV - Lipoatrophy, treatment experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EFV and Fixed combinations of analogues
Arm Type
Active Comparator
Arm Description
EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine
Arm Title
LPV/r and combination of analogues.
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
EFV
Intervention Description
one pill QD VO.
Intervention Type
Drug
Intervention Name(s)
LPV/r
Intervention Description
2 pills QD VO
Primary Outcome Measure Information:
Title
Absolute change in limb fat mass measured by DEXA.
Time Frame
24 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Hospital de Bellvitge
City
L'Hospitalet de LLobregat
State/Province
Barcelona
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Asturias
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau de Barcelona
City
Barcelona
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
Country
Spain
Facility Name
Hospital Xeral-Cíes
City
Vigo
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27089862
Citation
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, Martinez 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.
Results Reference
derived

Learn more about this trial

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

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