ROCKET II - Randomized Open Label Switch for Cholesterol Elevation on Kivexa + Kaletra Evaluation Trial
Information source: Gilead Sciences
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV-1
Intervention: Truvada (emtricitabine 200 mg/tenofovir DF 300 mg) and Kaletra (lopinavir 200 mg/ritonavir (Drug); Kivexa (abacavir (as sulfate) 600 mg/lamivudine and Kaletra (lopinavir 200 mg/ritonavir (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Gilead Sciences Official(s) and/or principal investigator(s):
Florian Abel, Study Director, Affiliation: Gilead Sciences
Overall contact:
Lothar Gallo, Phone: +498989989018, Email: lothar.gallo@gilead.com
Summary
This study aims to investigate whether subjects switching their NRTI backbone from Kivexa to
Truvada, who already have raised total cholesterol prior to switching, have an improvement
in their total cholesterol after 12 weeks of treatment. If an improvement is demonstrated
the study aims to show whether this has a beneficial effect on the patient's overall
cardiovascular risk and long term prognosis.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Primary outcome: The primary objective is to determine if switching the NRTI backbone from Kivexa to Truvada leads to a reduction in fasting total cholesterol at 12 weeks.
Secondary outcome: 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.
Detailed description:
This is a Phase 4, open-label, randomized, EU multicenter, controlled study to assess the
effect on lipid profile of switching from a stable HAART regimen of Kivexa + Kaletra to
Truvada + Kaletra in adult HIV-1 infected subjects with raised cholesterol.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- ≥ 18 years old
- Plasma HIV-1 RNA < 50 copies/mL for ≥ 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)
- Fasted total cholesterol ≥ 5. 2 mmol/L (≥ 200 mg/dL) 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
- 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)
- Serum Total Bilirubin ≤ 1. 5 mg/dL (Note: In cases of clinically insignificant,
asymptomatic elevated Serum Total Bilirubin (e. g. due to Gilbert Syndrome) the
subject may be enrolled in the study with Serum Total Bilirubin >1. 5 mg/dL with the
agreement of the Medical Monitor)
- Women of childbearing potential (WOCBP) must be using a highly effective method of
contraception to avoid pregnancy throughout the study and for up to 30 days 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
follicle stimulating hormone (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 30 days 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.
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), 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 > 1000 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.
- 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 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
Locations and Contacts
Lothar Gallo, Phone: +498989989018, Email: lothar.gallo@gilead.com
Gilead Sciences, Vienna 1220, Austria; Recruiting
Lothar Gallo, Phone: +49 89 89989018, Email: lothar.gallo@gilead.com
Gilead Sciences, Munich, Germany; Recruiting
Lothar Gallo, Phone: +4908989989018, Email: lothar.gallo@gilead.com
Gilead Sciences, Milan, Italy; Recruiting
Loredana Balzano, Phone: +39 02 43920239, Email: RosariaLoredana.Balzano@gilead.com
Gilead Sciences, Madrid, Spain; Recruiting
Ana Moreno, Phone: +34 91 378 98 30, Email: ana.moreno@gilead.com
Additional Information
Starting date: October 2008
Ending date: September 2009
Last updated: March 26, 2009
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