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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00978237
First received: September 15, 2009
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
HIV Infections
Lipoatrophy
Drug: EFV
Drug: LPV/r
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Absolute change in limb fat mass measured by DEXA. [ Time Frame: 24 months. ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT00978237     History of Changes
Other Study ID Numbers: LIPOKAL
Study First Received: September 15, 2009
Last Updated: February 21, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
HIV - Lipoatrophy
treatment experienced

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lipodystrophy
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus 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
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 10, 2014