Adult, HIV-1 infected, tenofovir DF- and emtricitabine-naive subjects on a stable HAART regimen of Kivexa (abacavir/lamivudine) and efavirenz, with raised total fasting cholesterol MedDRA version: 9.1 Level: LLT Classification code 10020192 Term: HIV-1
Conditions
Interventions
Trade Name: Atripla
Product Name: efavirenz/emtricitabine/tenofovir disoproxil fumarate
Product Code: ATR
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: efavirenz
CAS Number: 154598-52-4
Sponsors
Gilead Sciences Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • = 18 years old • Plasma HIV RNA =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Pregnant or lactating subjects • Previous treatment with emtricitabine (FTC), tenofovir DF (TDF) or adefovir dipivoxil (ADV) • Known hypersensitivity to emtricitabine (FTC), tenofovir DF (TDF), efavirenz (EFV) or Truvada • Documented resistance to any of the study drugs (either genotypic or phenotypic) • Severe hepatic impairment Hepatic transaminases (AST and 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 28 days prior to the Baseline visit and for the duration of the study period. • 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. Asymptomatic grade 4 abnormalities will be permitted at the discretion of the Investigator if deemed clinically appropriate (excluding AEs and laboratory parameters mentioned elsewhere in the inclusion/exclusion criteria). Abnormalities deemed insignificant by the Investigator must be discussed with the Sponsor 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 • 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 from a stable HAART regimen of Kivexa + EFV to once daily Atripla leads to a reduction in total fasting cholesterol at 12 weeks.;Secondary Objective: •Evaluation of fasting metabolic parameters (e.g., LDL, HDL, triglycerides, non-HDL cholesterol 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): Change from baseline in total fasting cholesterol at Week 12. | — |
Countries
United Kingdom
Outcome results
None listed