- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00978237
Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients (LIPOKAL)
September 17, 2014 updated by: Juan A. Arnaiz
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Asturias, Spain
- Hospital Universitario Central de Asturias
-
Barcelona, Spain
- Hospital Clínic de Barcelona
-
Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau de Barcelona
-
Madrid, Spain
- Hospital Clinico San Carlos
-
Valencia, Spain
- Hospital La Fe
-
Vigo, Spain
- Hospital Xeral-Cíes
-
-
Barcelona
-
L'Hospitalet de LLobregat, Barcelona, Spain
- Hospital de Bellvitge
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absolute change in limb fat mass measured by DEXA.
Time Frame: 24 months.
|
24 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (ACTUAL)
November 1, 2013
Study Completion (ACTUAL)
November 1, 2013
Study Registration Dates
First Submitted
September 15, 2009
First Submitted That Met QC Criteria
September 15, 2009
First Posted (ESTIMATE)
September 16, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 18, 2014
Last Update Submitted That Met QC Criteria
September 17, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIPOKAL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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