Sujetos adultos, infectados con el VIH-1, que están siendo tratados con un régimen TARGA estable de Kivexa + Kaletra, con colesterol elevado. Adult HIV-1 infected subjects on a stable HAART regimen of Kivexa + Kaletra, with raised cholesterol MedDRA version: 9.1 Level: LLT Classification code 10020192 Term: HIV-1
Conditions
Interventions
Trade Name: TRUVADA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: emtricitabine
CAS Number: 143491-57-0
Current Sponsor code: FTC
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Gilead Sciences Europe Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for participation in this study: • = 18 years old • Plasma HIV 1 RNA =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria are not to be enrolled in this study: • Pregnant or lactating subjects • Previous treatment with emtricitabine (FTC), tenofovir DF (TDF) or adefovir dipivoxil (ADV) • Known hypersensitivity to emtricitabine (FTC), tenofovir DF (TDF), Truvada or any of the excipients (e.g., lactose monohydrate, see 5.2.1) • Documented resistance to any of the study drugs (either genotypic or phenotypic) • Severe hepatic impairment • Hepatitis B infection with viral load > 1.000 copies/ml at Screening or Hepatitis C infection requiring therapy. • Treatment with any interferon or pegylated interferon within 18 months prior to Screening. • Hepatic transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) = 5 × upper limit of normal (ULN) • Subjects receiving ongoing therapy with any of the medications that are contraindicated with any of the study drugs. Administration of any of these medications must be discontinued at least 30 days prior to the Baseline visit and for the duration of the study period. The full list of disallowed medications can be found in Appendix 5 of the protocol. • Active, serious infections (other than HIV infection) requiring parenteral antibiotic therapy within 15 days prior to screening • Prior history of significant renal or bone disease • Any current known clinical or symptomatic laboratory parameter of GSI Grade 4 (see Appendix 4). Asymptomatic Grade 4 abnormalities will be permitted at the discretion of the investigator if deemed clinically appropriate (excluding adverse events and laboratory parameters mentioned elsewhere in the inclusion/exclusion criteria). Abnormalities deemed insignificant by the investigator must be discussed with the Medical Monitor prior to enrollment. • Malignancy other than cutaneous Kaposi sarcoma (KS) or basal cell carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of baseline and are not anticipated to require systemic therapy during the study • 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 has been stopped for more than 1 month prior to baseline • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if switching the NRTI backbone from a Kivexa to Truvada leads to a reduction in fasting total cholesterol at 12 weeks.;Secondary Objective: • Evaluation of fasting metabolic parameters (e.g., LDL, HDL, non-HDL cholesterol, triglycerides, and cholesterol ratios). • Evaluation of efficacy and safety by assessing adverse events, clinical laboratory tests, physical examinations and vital signs at every visit. • Evaluation of changes in the 10-year risk factor for coronary heart disease outcomes as measured by total cholesterol, HDL, blood pressure, smoking status, treatment for hypertension, sex and age.;Primary end point(s): The primary efficacy endpoint is change from baseline in total cholesterol at Week 12. | — |
Countries
Austria, Germany, Italy, Spain
Outcome results
None listed