A Phase 4, Open Label, Randomized, Controlled Study to Assess the Effect on Lipid Profile of Switching a Stable HAART Regimen of fixed dose Abacavir/Lamivudine (Kivexa) Plus Lopinavir/Ritonavir (Kaletra), to Emtricitabine/Tenofovir Disoproxil Fumarate (Truvada) Plus Lopinavir/Ritonavir (Kaletra) in Adult HIV-1 Infected Subjects With Raised Cholesterol - ROCKET II- Randomized Open Label Switch for Cholesterol Elevation on Kivexa+Kaletra Evaluation Trial

Gilead Sciences Europe Ltd.0 sites160 target enrollmentJuly 25, 2008

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adult HIV-1 infected subjects on a stable HAART regimen of Kivexa + Kaletra, with raised cholesterol
Sponsor: Gilead Sciences Europe Ltd.
Enrollment: 160
Status: Active, not recruiting
Last Updated: 12 years ago

No summary available.

Registry

who.int

Start Date

July 25, 2008

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
•\= 18 years old
•Plasma HIV 1 RNA \< 50 copies/mL at Screening and \= 12 weeks prior to Screening
•Stable HAART regimen of Kivexa \+ Kaletra for \= 24 weeks prior to Screening
•Documented confirmed raised total cholesterol \= 5\.2 mmol/L (\= 200 mg/dL) for the last two consecutive tests (at least 4 weeks apart)
•Documented confirmed total cholesterol \= 5\.2 mmol/L (\= 200 mg/dL) for last two consecutive testings (at least 4 weeks apart) prior to Screening and fasting total cholesterol \= 5\.2 mmol/L at Screening
•Subject willing to continue current unmodified HAART for 12 weeks if randomized to Group 2
•Subjects requiring concomitant lipid regulating therapy must be established on a stable dose/frequency \= 12 weeks prior to Screening and be expected to remain stable in dose and frequency throughout the treatment phase of the study. Simvastatin and lovastatin are not allowed (see 4\.3\. Exclusion Criteria and Appendix 5 in the protocol)
•Adequate renal function by calculated creatinine clearance \= 60 mL/min according to the Cockcroft–Gault formula
•Negative serum pregnancy test (females of childbearing potential only i.e., not surgically sterile or at least 2 years post\-menopausal)

•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 28 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.