Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00978237

Acronym

LIPOKAL

Enrollment

Registered

2009-09-16

Start date

2009-10-31

Completion date

2013-11-30

Last updated

2014-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Lipoatrophy

Keywords

HIV - Lipoatrophy, treatment experienced

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.

Interventions

DRUGEFV

one pill QD VO.

DRUGLPV/r

2 pills QD VO

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Absolute change in limb fat mass measured by DEXA.	24 months.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026