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.
Information provided by (Responsible Party):
Juan A. Arnaiz, Hospital Clinic of Barcelona
First received: September 15, 2009
Last updated: February 21, 2013
Last verified: February 2013
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.
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||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.
Primary Outcome Measures:
- Absolute change in limb fat mass measured by DEXA. [ Time Frame: 24 months. ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2013 (Final data collection date for primary outcome measure)
Active Comparator: EFV and Fixed combinations of analogues
EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine
one pill QD VO.
Experimental: LPV/r and combination of analogues.
2 pills QD VO
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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
|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 |
|Vigo, Spain |
Juan A. Arnaiz
No publications provided
||Juan A. Arnaiz, MD, PhD, Hospital Clinic of Barcelona
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 15, 2009
||February 21, 2013
||Spain: Spanish Agency of Medicines
Keywords provided by Hospital Clinic of Barcelona:
HIV - Lipoatrophy
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 26, 2014
Acquired Immunodeficiency Syndrome
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Skin Diseases, Metabolic
Lipid Metabolism Disorders
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action