Status:
COMPLETED
Trial To Assess The Lipid-Lowering Effect Of Adding Tenofovir/Emtricitabine Co-Formulation Vs Placebo To Hiv-1-Infected Subjects With Dyslipidemia And Sustained Viral Load Suppression Under Monotherapy With Ritonavir-Boosted Protease Inhibitors
Lead Sponsor:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Conditions:
HIV
Dyslipidemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This is a phase IV, multicenter, prospective, randomised, crossover, double blind, placebo-controlled and proof of concept clinical trial. All subjects fulfilling inclusion criteria will be randomise...
Detailed Description
This is a phase IV, multicenter,, prospective, randomised, crossover, double blind, placebo-controlled and proof of concept clinical trial. The trial was conducted in a total sample of 60 patients (30...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Chronic HIV-1 infection
- Antiretroviral treatment with either DRV/r (800/100 mg QD) or LPV/r (400/100 mg BID) monotherapy during at least 6 months prior to screening.
- Fasting total cholesterol or LDL-cholesterol levels ≥ 200 and ≥130 mg/dL respectively, in the previous two consecutive tests obtained at least 4 weeks apart before screening.
- Calculated creatinine clearance ≥ 60 mL/min, according to the Cockcroft-Gault formula.
- Undetectable plasma HIV-1 RNA levels (\< 50 copies/mL) during at least 6 months prior to screening.
- Adequate treatment adherence.
- Absence of TDF or FTC resistances.
- Written informed consent to participate into the study.
Exclusion
- Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study
- Lactating, pregnancy or fertile women willing to be pregnant.
- Concomitant use of any drug with potential drug-drug interaction with DRV/r, LPV/r or TDF/FTC co-formulation at study entry.
- Concomitant use of any lipid-lowering drugs at study entry.
- Prior documented intolerance or hypersensitivity to TDF, FTC, LPV/r or DRV/r.
- Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
- Acute or chronic renal documented pathologies.
- Documented resistance to any of the study drugs (either genotypic or phenotypic)
- Life expectancy less or equal to 1 year.
- Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance.
- Subjects currently taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied have stopped for more than 12 weeks.
- Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01458977
Start Date
January 1 2012
End Date
February 1 2014
Last Update
June 19 2014
Active Locations (3)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
2
Hospital Valle Hebrón
Barcelona, Barcelona, Spain, 08035
3
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain