Status:
UNKNOWN
Effects of 2 Initial Standard Antiretroviral Combinations Therapies on Lipid Metabolism
Lead Sponsor:
Juan A. Arnaiz
Collaborating Sponsors:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Germans Trias i Pujol Hospital
Conditions:
HIV Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is an open-label, randomized, pilot comparison of the effects of either lopinavir/ritonavir or efavirenz in combination with tenofovir plus emtricitabine on cholesterol metabolism, mitochon...
Eligibility Criteria
Inclusion
- Chronic HIV-1 infection
- Age 18 or above
- Antiretroviral-naive
- Criteria for antiretroviral therapy in accordance with current guidelines
- Plasma LDL-cholesterol below 190 mg/dL
- Not receiving lipid-lowering agents
- Written informed consent
Exclusion
- Use of phytosterol-enriched food previous month.
- Pregnancy or breastfeeding
- Cardiovascular disease
- Secondary Hypercholesterolemia
- Plasma creatinine above 1,2 mg/dL)
- Aminotransferases above 5 times ULN
- Current treatment for hepatitis C coinfection
- Diabetes mellitus (fasting glycemia \> 124 mg/dL)
- Illegal drug use or alcohol abuse
- Active AIDS-defining opportunistic disease
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00759070
Start Date
September 1 2008
End Date
July 1 2013
Last Update
February 22 2013
Active Locations (5)
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1
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
2
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain, 08025
3
Hospital Clinic
Barcelona, Barcelona, Spain, 08036
4
Hospital Universitario Virgen del Rocío
Seville, Sevilla, Spain, 41013