Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients (LIPOKAL)
Juan A. Arnaiz
Information provided by (Responsible Party)
Juan A. Arnaiz, Hospital Clinic of Barcelona
First received: September 15, 2009
Last updated: September 17, 2014
Last Verified: September 2014
History of Changes
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.
Drug : EFV
Drug : LPV/r
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.|
Further study details as provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:
Primary Outcome Measures
- Absolute change in limb fat mass measured by DEXA. [ Time Frame: 24 months. ]
|Study Start Date:||October 2009|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
EFV and Fixed combinations of analogues
EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine
one pill QD VO.
LPV/r and combination of analogues.
2 pills QD VO
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
Contacts and LocationsChoosing 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 Show More
|Hospital de Bellvitge|
|L'Hospitalet de LLobregat, Barcelona, Spain|
|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|
Sponsors and CollaboratorsJuan A. Arnaiz
|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:||September 17, 2014|
Keywords provided by Juan A. Arnaiz, Hospital Clinic of Barcelona:HIV - Lipoatrophy
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on December 15, 2017
This information is provided by ClinicalTrials.gov.