Study 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

Conditions: HIV-1 infection
MedDRA version: 14.0Level: LLTClassification code 10068341Term: HIV-1 infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2011-002853-77-ES

Lead Sponsor: Fundació Lluita contra la SIDA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1.Age = 18 years
2.Chronic HIV-1 infection
3.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.
4.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.
5.Calculated creatinine clearance ? 60 mL/min, according to the Cockcroft-Gault formula.
6.Undetectable plasma HIV-1 RNA levels (< 50 copies/mL) during at least 6 months prior to screening.
7.Adequate treatment adherence.
8.Absence of TDF or FTC resistances.
9.Written informed consent to participate into the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.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
2.Lactating, pregnancy or fertile women willing to be pregnant.
3.Concomitant use of any drug with potential drug-drug interaction with DRV/r, LPV/r or TDF/FTC co-formulation at study entry.
4.Concomitant use of any lipid-lowering drugs at study entry.
5.Prior documented intolerance or hypersensitivity to TDF, FTC, LPV/r or DRV/r.
6.Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
7.Acute or chronic renal documented pathologies.
8.Documented resistance to any of the study drugs (either genotypic or phenotypic)
9.Life expectancy less or equal to 1 year.
10.Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance.
11.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.
12.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.