Overview

ROCKET II - Randomized Open Label Switch for Cholesterol Elevation on Kivexa + Kaletra Evaluation Trial

Status:
Completed
Trial end date:
2009-10-01
Target enrollment:
0
Participant gender:
All
Summary
This study investigated whether human immunodeficiency virus type 1 (HIV-1) infected subjects with raised cholesterol switching their nucleoside reverse transcriptase inhibitor (NRTI) backbone from Kivexa (Epzicom) to Truvada had an improvement in their fasting total cholesterol after 12 weeks of treatment. The study also investigated whether any improvement had a beneficial effect on the overall cardiovascular risk.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Abacavir
Emtricitabine
Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Lamivudine
Lopinavir
Ritonavir
Tenofovir
Criteria
Inclusion Criteria:

- ≥ 18 years old

- Plasma HIV-1 RNA < 50 copies/mL at screening and 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. Simvastatin and
lovastatin are not allowed.

- 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)

- 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 Gilead Sciences,
Inc., 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