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

HIV Infections Clinical Trial

— LIPOKAL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00978237
• Other study ID #: LIPOKAL
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2009
• Last updated: September 17, 2014
• Start date: October 2009
• Est. completion date: November 2013

Study information

• Verified date: September 2014
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Lipoatrophy
• Lipodystrophy

Intervention

Drug:
• EFV
one pill QD VO.
• LPV/r
2 pills QD VO

Locations

Country	Name	City	State
Spain	Hospital Universitario Central de Asturias	Asturias
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau de Barcelona	Barcelona
Spain	Hospital de Bellvitge	L'Hospitalet de LLobregat	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital La Fe	Valencia
Spain	Hospital Xeral-Cíes	Vigo

Sponsors (1)

Lead Sponsor	Collaborator
Juan A. Arnaiz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change in limb fat mass measured by DEXA.		24 months.	Yes