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HIV-1Phase 4ROCKET IINCT00772902

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

A Phase 4 study testing Truvada + Kaletra and Kivexa + Kaletra in people with HIV-1, run by Gilead Sciences at 4 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV-1
What is being tested?
Truvada + Kaletra and Kivexa + Kaletra
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
4 sitesin 4 countries
Study dates
Oct 2008to Oct 2009
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 4 countries.

4 sites in 4 countries

Austria1 site

  • Gilead Sciences

    Vienna, 1220

Other trials in Austria

Germany1 site

  • Gilead Sciences

    Munich

Other trials in Germany

Italy1 site

  • Gilead Sciences

    Milan

Other trials in Italy

Spain1 site

  • Gilead Sciences

    Madrid

Other trials in Spain

About this study

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

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.

Read the detailed description

This was a Phase 4, open-label, randomized, multicenter (in the European Union), controlled study to assess the effect on lipid profile of switching from a stable highly active antiretroviral therapy (HAART) regimen of Kivexa + Kaletra to Truvada + Kaletra in adult HIV-1 infected subjects with raised cholesterol.

Conditions
HIV-1
Being tested
Truvada + Kaletra, Kivexa + Kaletra
Keywords
HIV-1, LDL, HDL, non-HDL cholesterol, triglycerides, cholesterol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Truvada + KaletraDrug

    Truvada (emtricitabine 200 mg/tenofovir DF 300 mg)once daily for oral administration according to prescription information. As third agent, continuing Kaletra (lopinavir 200 mg/ritonavir 50 mg) for oral administration according to prescription.

  • Kivexa + KaletraDrug

    Also called Kivexa = Epzicom

    Continuing Kivexa (abacavir sulfate 600 mg/lamivudine 300 mg) once daily for oral administration according to prescription. As third agent, continuing Kaletra (lopinavir 200 mg/ritonavir 50 mg) for oral administration according to prescription.

Study groups in NCT00772902
Study groupRoleWhat they receive
Truvada + KaletraExperimentalTruvada (emtricitabine 200 mg/tenofovir DF 300 mg) once daily for oral administration according to prescription information. As third agent, continuing Kaletra (lopinavir 200 mg/ritonavir 50 mg) for oral administration according to prescription.
Receives: Drug: Truvada + Kaletra
Kivexa + KaletraActive comparatorContinuing Kivexa (abacavir sulfate 600 mg/lamivudine 300 mg) once daily for oral administration according to prescription. As third agent, continuing Kaletra (lopinavir 200 mg/ritonavir 50 mg) for oral administration according to prescription.
Receives: Drug: Kivexa + Kaletra

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

Secondary outcomes (3)

  1. Evaluation of fasting metabolic parameters (e.g. LDL, HDL, non-HDL cholesterol, triglycerides and cholesterol ratios).

    Measured: 12 weeks

  2. Evaluation of efficacy and safety by assessing adverse events, clinical laboratory tests, physical examinations and vital signs at every visit.

    Measured: Upto 12 weeks

  3. 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.

    Measured: 10 year risk factor from 12 week evaluation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionSep 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00772902
Sponsor's protocol ID
GS-EU-164-0206
Other IDs
2008-002043-16, 2008
Acronym
ROCKET II
Status last verified
Nov 2011
First submitted
13 Oct 2008
Last updated
21 Nov 2011
Results posted
No
Data monitoring committee
No

Publications

  • Behrens G, Maserati R, Rieger A, Domingo P, Abel F, Wang H, Pearce G. Switching to tenofovir/emtricitabine from abacavir/lamivudine in HIV-infected adults with raised cholesterol: effect on lipid profiles. Antivir Ther. 2012;17(6):1011-20. doi: 10.3851/IMP2305. Epub 2012 Aug 15.

    PubMed 22910324

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Truvada + Kaletra and Kivexa + Kaletra in people with HIV-1, run by Gilead Sciences at 4 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Austria, Germany, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00772902, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2011.

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