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HIV InfectionsPhase 4ROCKET INCT00615810

ROCKET I - Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial

A Phase 4 study testing Atripla and Kivexa plus Sustiva in people with HIV Infections, run by Gilead Sciences at 1 site in United Kingdom.

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 aims to investigate whether patients switching their 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections
What is being tested?
Atripla and Kivexa plus Sustiva
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
1 siteUnited Kingdom
Study dates
Mar 2008to Jan 2010
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

  • Equal to or greater to 18 years old
  • Plasma HIV RNA less than 50 copies/mL equal to or greater than 12 weeks prior to Screening
  • Stable HAART regimen of Kivexa + EFV for equal to or greater than 24 weeks prior to Screening
  • Documented confirmed raised total cholesterol greater than or equal to 5.2 mmol/L for last two consecutive tests (at least 4 weeks apart) with the last result less than or equal to 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 greater than or equal to 12 weeks prior to Screening and be expected to remain stable in dose and frequency throughout the treatment phase of the study
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  • Adequate renal function by calculated creatinine clearance greater than or equal to 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 ≤ 1.5 mg/dL
  • 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. Subjects may choose two (barrier plus highly effective method - see section 7.8 for further discussion) of the birth control methods listed below:
  • Hormonal birth control drugs
  • Male or female condoms with or without spermicidal gels
  • Diaphragm cervical cap with or without spermicidal gels
  • Intrauterine device
  • Female subjects who utilize hormone contraceptive as one of their birth control methods must have used the same methods for at least 3 months prior to study dosing
  • Female subjects who are postmenopausal for less than 2 years are required to have FSH greater or equal to 40 mIU/mL. If the FSH is less than 40 mIU/mL, the subject must agree to use highly effective method of birth control (as described above) 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 greater to or equal to 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), efavirenz (EFV) or Truvada
  • Documented resistance to any of the study drugs (either genotypic or phenotypic)
  • Severe hepatic impairment
  • Hepatic transaminases (AST and ALT) greater or equal to 5 times the upper limit of normal (ULN)
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  • 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 30 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 7.
  • 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Gilead Sciences

    Granta Park, Cambridge, Abington, CB21 6GT

Other trials in United Kingdom

About this study

Official title: 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/Lamivudine (Kivexa) Plus Efavirenz, to Once Daily Atripla in Adult HIV-1 Infected Subjects With Raised Cholesterol

This study aims to investigate whether patients switching their 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.

Read the detailed description

This protocol is a Phase 4, open label, randomized, UK multi-center, controlled study to assess the effect on lipid profile of switching from a stable HAART regimen of Kivexa + EFV to once daily Atripla in adult HIV 1 infected subjects with raised cholesterol.

At Baseline, subjects will be randomized 1:1 to one of two treatment groups:

Treatment Group 1: switch to Atripla Treatment Group 2: Continuation of previous stable HAART regimen of Kivexa + EFV Initiation of treatment with study drugs must take place within 24 hours after Baseline visit. At Week 12, subjects in Treatment Group 2 (continuation of Kivexa and EFV regimen) will switch to Atripla. Treatment in both groups will continue through Week 24

Conditions
HIV Infections
Being tested
Atripla, Kivexa plus Sustiva
Keywords
LDL, HDL, triglycerides, non HDL cholesterol, cholesterol, HIV 1, Metabolic parameters, treatment experienced
Medical subject headings
HIV Infections

What participants receive

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

  • AtriplaDrug

    Open label once daily for oral administration to be taken on an empty stomach

  • Kivexa plus SustivaDrug

    Open label once daily for oral administration

Study groups in NCT00615810
Study groupRoleWhat they receive
2Active comparatorOpen label Kivexa (abacavir (as sulfate) 600 mg/lamivudine 300 mg) once daily for oral administration plus Sustiva (efavirenz 600 mg) once daily for oral administration
Receives: Drug: Kivexa plus Sustiva
1ExperimentalOpen label Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir DF 300 mg) once daily for oral administration to be taken on an empty stomach
Receives: Drug: Atripla

What is being measured

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

  1. Change from baseline in total fasting cholesterol at Week 12.

    Measured: 12 Weeks

Secondary outcomes (2)

  1. Change in total fasting cholesterol at Week 24

    Measured: 24 fweeks

  2. Changes in fasting LDL, HDL, triglycerides, non-HDL cholesterol and cholesterol ratios

    Measured: 24 weeks

Timeline

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

  1. First posted14 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionOct 2009
  4. Study completionJan 2010

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
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00615810
Sponsor's protocol ID
GS-UK-177-0109
Other IDs
2007-003354-28 EudraCT Number
Acronym
ROCKET I
Status last verified
Jul 2010
First submitted
1 Feb 2008
Last updated
2 Aug 2010
Results posted
No
Data monitoring committee
No

Publications

  • Moyle GJ, Orkin C, Fisher M, Dhar J, Anderson J, Wilkins E, Ewan J, Ebrahimi R, Wang H; ROCKET 1 (Randomized Open Label Switch for Cholesterol Elevation on Kivexa Evaluation Trial) Study Group. A randomized comparative trial of continued abacavir/lamivudine plus efavirenz or replacement with efavirenz/emtricitabine/tenofovir DF in hypercholesterolemic HIV-1 infected individuals. PLoS One. 2015 Feb 6;10(2):e0116297. doi: 10.1371/journal.pone.0116297. eCollection 2015.

    PubMed 25658097

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Atripla and Kivexa plus Sustiva in people with HIV Infections, run by Gilead Sciences at 1 site in United Kingdom.

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 20 inclusion and 14 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 2 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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?

Change from baseline in total fasting cholesterol at Week 12. (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 NCT00615810, 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 2 Aug 2010.

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