HIV-1 infection
Conditions
Sponsors
Abbott GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety, tolerability, and antiviral activity of two treatment strategies in HIV-1/HCV co-infected subjects: -LPV/r-based induction/maintenance strategy; -EFV-based three-drug regimen.;Secondary Objective: Compare the durability of viral suppression of a lopinavir/ritonavir vs.efavirenz based regimen when administered over 96 weeks in antiretroviral?naïve HIV-1/HCV co-infected subjects.Evaluate the effect of demographic and baseline disease characteristics on the antiviral and immunologic response in both treatment strategies. Characterize the development of resistance in both treatment strategies. Assess adverse events and changes in laboratory determinations in both treatment strategies. Assess the hepatic effects associated with the treatment strategies as reflected by changes in laboratory determinations and adverse events. Assess the metabolic effects associated with the treatment strategies as reflected by changes in laboratory determinations. ;Primary end point(s): The primary efficacy analysis will be the proportion of subjects with HIV-1 RNA < 50 copies/mL at Week 96. The proportion of subjects reporting treatment-emergent adverse events will be summarized within each treatment arm by severity and relationship to study drug. Fisher's exact test will be used to compare the overall incidence rates between the two treatment arms. The mean change from baseline to each visit in clinical laboratory determinations, vital signs, and physical examination determinations will be summarized and compared between treatment arms. | — |
Countries
Ireland, United Kingdom
Outcome results
None listed