EUCTR2008-002043-16-IT
Active, not recruiting
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV-1 infection
- Sponsor
- Gilead Sciences Europe Ltd
- Enrollment
- 160
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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)
Outcomes
Primary Outcomes
Not specified
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