A Randomized, Open Label Study Assessing Safety, Tolerability, and Efficacy of an Induction/Maintenance Treatment Strategy Including Lopinavir/ritonavir (LPV/r) plus Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine (FTC) versus Efavirenz (EFV) plus TDF and FTC in Antiretroviral-Naïve HIV-1/HCV Co-infected Subjects
- Conditions
- HIV-1 infection
- Registration Number
- EUCTR2005-001431-30-GB
- Lead Sponsor
- Abbott GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
The main criteria for inclusion are:
Adult male and female patients who have provided written informed consent.
Plasma HIV-1 RNA>1000 copies/mL and in the investigator's opinion requires HIV therapy.
Baseline HIV-1 genotypic resistance testing showing susceptibility to EFV,LPV,TDF and FTC (or 3TC).Subject is naive to antiviral therapy or has had <7 days total of any antiretroviral therapy >30 days prior to study drug administration;subject has chronic hepatitis C Virus (HCV) based on HCV RNA at screening; subject not currently undergoing treatment for HCV; Female subjects is not pregnant or breast feeding. Not taking and not planned to need medications contraindicated with LPV/r, EFV TDF or FTC.
Are the trial subjects under 18?
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)
F.1.3.1 Number of subjects for this age range
Subjects with a history of allergic reaction to lopinavir or to any of the other drugs or inert materials in the study drug formulations; subjects with a significant history of cardiac, neurologic, psychiatric, oncologic or metabolic disease that the Investigator feels would adversely affect his/her participation; chronic hepatitis infection of any other sort apart from HCV; liver biopsy consistent with chronic cirrhosis or a Child Pugh score of C. If for any reason the subject is considered to be an unsuitable candidate by the Investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method