A Phase 4, Open Label, Randomized, Controlled Study to Assess the Effect on Lipid Profile of Switching from a Stable HAART Regimen of fixed dose Abacavir/Lamivuidine (Kivexa) Plus Efavirenz, to Once Daily Atripla in Adult HIV-1 Infected Subjects With Raised Cholesterol - ROCKET - Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial

Gilead Sciences Limited0 个研究点开始时间: 2007年12月21日最近更新: 2012年3月19日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•= 18 years old
•Plasma HIV RNA < 50 copies/mL = 12 weeks prior to Screening
•Stable HAART regimen of Kivexa + EFV for = 24 weeks prior to Screening
•Documented confirmed raised total cholesterol = 5.2 mmol/L for last two consecutive tests (at least 4 weeks apart) with the last result = 4 weeks prior to 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
•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)
•Hepatic Total Bilirubin = 22 umol/L
•Adequate haematologic function of absolute neutrophil count = 1000/mm3, platelets = 25,000/mm3, Haemoglobin = 8.0g/dL
•Women of childbearing potential (WOCBP) must be using two methods of contraception to avoid pregnancy throughout the study and for up to 12 weeks after the last dose of study drugs in such a manner that the risk of pregnancy is minimized.
•Female subjects who are postmenopausal for less than 2 years are required to have FSH = 40 mIU/mL. If the FSH is < 40 mIU/mL, the subject must agree to use highly effective method of birth control to participate in the study
•Male subjects who are sexually active must be willing to use effective barrier contraception (e.g. condom with spermicide) during heterosexual intercourse from screening through completion of the study and continuing for up to 12 weeks after the last dose of study drugs
•Life expectancy = 1 year
•The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

排除标准

•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

研究者

发起方

Gilead Sciences Limited

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