A phase 4, open label, randomised, controlled study to assess the effect on lipid profile of switching a stable HAART regimen of fixed dose Kivexa + Kaletra to Truvada + Kaletra in adult HIV-1 infected subjects with raised cholesterol - Rocket II

• Register: EUCTR
• Last refreshed on: 18 April 2012
• Main ID: EUCTR2008-002043-16-IT
• Date of registration: 05/11/2008
• Prospective Registration: No
• Primary sponsor: Gilead Sciences Europe Ltd
• Public title: A phase 4, open label, randomised, controlled study to assess the effect on lipid profile of switching a stable HAART regimen of fixed dose Kivexa + Kaletra to Truvada + Kaletra in adult HIV-1 infected subjects with raised cholesterol - Rocket II
• Scientific title: A phase 4, open label, randomised, controlled study to assess the effect on lipid profile of switching a stable HAART regimen of fixed dose Kivexa + Kaletra to Truvada + Kaletra in adult HIV-1 infected subjects with raised cholesterol - Rocket II
• Date of first enrolment: 03/09/2008
• Target sample size: 160
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002043-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria, Germany, Italy, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
Documented confirmed total fasted cholesterol > or = 5.2 mmol/L (= or > 200 mg/dL) for last two consecutive testings (at least 4 weeks apart) with last result < or = 4 weeks prior to Screening
Plasma HIV 1 RNA < 50 copies/mL at Screening and > or = 12 weeks prior to Screening
Stable HAART regimen of ABC/3TC + LPV/r for at least 24 weeks prior to Screening
No previous TDF, FTC or Adefovir (ADV) therapy
No Hepatitis B infection with viral load > 1000 copies/mL and no Hepatitis C infection requiring therapy
No treatment with any interferon or pegylated interferon within 18 months prior to Screening
Concomitant lipid regulating therapy is permitted but must be stable for at least 12 weeks prior to Screening and remain stable throughout the treatment phase of the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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]) = or > 5 upper limit of normal (ULN)
. etc.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

HIV-1 infection
MedDRA version: 9.1 Level: LLT Classification code 10020192 Term: HIV-1

Intervention(s)

Trade Name: TRUVADA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tenofovir disoproxil fumarate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
INN or Proposed INN: emtricitabine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-

Trade Name: KIVEXA
Pharmaceutical Form: Tablet
INN or Proposed INN: abacavir sulfate
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
INN or Proposed INN: LAMIVUDINE
CAS Number: 134678-17-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Trade Name: KALETRA*FL120CPR RIV 200+50MG
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: LOPINAVIR
CAS Number: 192725-17-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
INN or Proposed INN: RITONAVIR
CAS Number: 155213-67-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: 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.

Primary end point(s): Change from baseline in fasting total cholesterol at Week 12.

Secondary Objective: 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.

Secondary ID(s)

GS-EU-164-0206

2008-002043-16-ES