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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lipoatrophy
Keywords: HIV - Lipoatrophy
treatment experienced
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2009-09-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Absolute change in limb fat mass measured by DEXA.
timeFrame: 24 months.
Secondary outcomes:
Other outcomes:
Locations:
city: L'Hospitalet de LLobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Asturias
country: Spain
facility: Hospital Universitario Central de Asturias
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau de Barcelona
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Valencia
country: Spain
facility: Hospital La Fe
city: Vigo
country: Spain
facility: Hospital Xeral-Cíes
Study officials:
References:
citation: Rojas J, Lonca M, Imaz A, Estrada V, Asensi V, Miralles C, Domingo P, Montero M, del Rio L, Fontdevila J, Perez I, Cruceta A, Gatell JM, Arnedo M, Martinez E. Improvement of lipoatrophy by switching from efavirenz to lopinavir/ritonavir. HIV Med. 2016 May;17(5):340-9. doi: 10.1111/hiv.12314. Epub 2015 Sep 10.