Brief Title
Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients
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.
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Absolute change in limb fat mass measured by DEXA.
Condition
HIV Infections
Intervention
EFV
Study Arms / Comparison Groups
EFV and Fixed combinations of analogues
Description: EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
20
Start Date
October 2009
Completion Date
November 2013
Primary Completion Date
November 2013
Eligibility 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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT00978237
Organization ID
LIPOKAL
Responsible Party
Sponsor-Investigator
Study Sponsor
Juan A. Arnaiz
Study Sponsor
, ,
Verification Date
September 2014