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

Juan A. Arnaiz

Status and phase

Completed

Phase 4

Conditions

Lipoatrophy

HIV Infections

Treatments

Drug: EFV

Drug: LPV/r

Study type

Interventional

Funder types

Other

Identifiers

NCT00978237

LIPOKAL

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.