NCT00978237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 hiv-infections

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_4 hiv-infections

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 18, 2014

Status Verified

September 1, 2014

Enrollment Period

4.1 years

First QC Date

September 15, 2009

Last Update Submit

September 17, 2014

Conditions

HIV InfectionsLipoatrophy

Keywords

HIV - Lipoatrophytreatment experienced

Outcome Measures

Primary Outcomes (1)

  • Absolute change in limb fat mass measured by DEXA.

    24 months.

Study Arms (2)

EFV and Fixed combinations of analogues

ACTIVE COMPARATOR

EFV + Fixed combinations of analogue tenofovir + emtricitabine, or abacavir + lamivudine

Drug: EFV

LPV/r and combination of analogues.

EXPERIMENTAL
Drug: LPV/r

Interventions

EFVDRUG

one pill QD VO.

EFV and Fixed combinations of analogues
LPV/rDRUG

2 pills QD VO

LPV/r and combination of analogues.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Hospital Universitario Central de Asturias

Asturias, Spain

Location

Hospital Clínic de Barcelona

Barcelona, Spain

Location

Hospital de la Santa Creu i Sant Pau de Barcelona

Barcelona, Spain

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Hospital Xeral-Cíes

Vigo, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27089862DERIVED

MeSH Terms

Conditions

HIV InfectionsLipodystrophy

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSkin Diseases, MetabolicSkin DiseasesSkin and Connective Tissue DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

September 15, 2009

First Posted

September 16, 2009

Study Start

October 1, 2009

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

September 18, 2014

Record last verified: 2014-09

Locations

ES(7)