Status:
COMPLETED
Clinical Trial to Assess the Effect of the Change of Efavirenz (EFV) for Lopinavir/Ritonavir (LPV/r) in Lipoatrophy in HIV-infected Patients
Lead Sponsor:
Juan A. Arnaiz
Conditions:
HIV Infections
Lipoatrophy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00978237
Start Date
October 1 2009
End Date
November 1 2013
Last Update
September 18 2014
Active Locations (7)
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1
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
2
Hospital Universitario Central de Asturias
Asturias, Spain
3
Hospital Clínic de Barcelona
Barcelona, Spain
4
Hospital de la Santa Creu i Sant Pau de Barcelona
Barcelona, Spain