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

NCT00615810 | Completed Phase 4

• 2 other identifiers: GS-UK-177-01092007-003354-28 EudraCT Number
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

HIV Infections

Keywords

LDL; HDL; triglycerides; non HDL cholesterol; cholesterol; HIV 1; Metabolic parameters; treatment experienced

Outcome Measures

Primary Outcomes (1)

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

  12 Weeks

Secondary Outcomes (2)

• Change in total fasting cholesterol at Week 24

  24 fweeks

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

  24 weeks

Study Arms (2)

2

ACTIVE COMPARATOR

Open 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

Drug: Kivexa plus Sustiva

1

EXPERIMENTAL

Open label Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir DF 300 mg) once daily for oral administration to be taken on an empty stomach

Drug: Atripla

Interventions

Atripla DRUG

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

1

Kivexa plus Sustiva DRUG

Open label once daily for oral administration

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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
• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (1)

Gilead Sciences

Granta Park, Cambridge, Abington, CB21 6GT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 25658097 DERIVED

MeSH Terms

Conditions

HIV Infections

Interventions

Efavirenz, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; abacavir, lamivudine drug combination; efavirenz

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tenofovir; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Emtricitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Cham Herath

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 14, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2010
• Last Updated: August 2, 2010

Record last verified: 2010-07

Locations

GB (1)