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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)

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ClinicalTrials.gov Identifier: NCT00978237
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
HIV Infections Lipoatrophy Drug: EFV Drug: LPV/r Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2009
Primary Completion Date : November 2013
Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Efavirenz
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: EFV and Fixed combinations of analogues
EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine
Drug: EFV
one pill QD VO.
Experimental: LPV/r and combination of analogues. Drug: LPV/r
2 pills QD VO


Outcome Measures

Primary Outcome Measures :
  1. Absolute change in limb fat mass measured by DEXA. [ Time Frame: 24 months. ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

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): NCT00978237


Locations
Spain
Hospital de Bellvitge
L'Hospitalet de LLobregat, Barcelona, Spain
Hospital Universitario Central de Asturias
Asturias, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau de Barcelona
Barcelona, Spain
Hospital Clínico San Carlos
Madrid, Spain
Hospital La Fe
Valencia, Spain
Hospital Xeral-Cíes
Vigo, Spain
Sponsors and Collaborators
Juan A. Arnaiz
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00978237     History of Changes
Other Study ID Numbers: LIPOKAL
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014

Keywords provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:
HIV - Lipoatrophy
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers