A 96 Week Phase IIIB Study Comparing the Antiviral Efficacy and Safety of Atazanavir/ritonavir ATV/RTV with Lopinavir/ritonavir LPV/RTV , Each in Combination with Fixed Dose Tenofovir-Emtricitabine in HIV-1 infected treatment naive subjects. - Castle

• Conditions: HIV-1 Infected Treatment Naive subjects; MedDRA version: 6.1Level: HLTClassification code 10038997

• Registration Number: EUCTR2005-001895-11-IT
• Lead Sponsor: BRISTOL-M.SQUIBB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07-17
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Antiretroviral-na ve HIV-1 infected subjects with no contraindication to study medications. Subjects must have a confirmed plasma HIV-1 RNA level 61619;2000 c/mL and an absolute CD4 count 61619; 50 cells/mm3.
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

Woman who are pregnant or breast feeding; Suspected primary acute HIV infection; Any antiretroviral therapy within 30 days prior to screening; Prior antiviral therapy / 1 week; Presence of cardiomiopathy or any significant cardiovascular disease; Screening laboratory values measured as follows calculated creatinine clearance 60 mL/min; total serum lipase / 1.4 times the upper limit of normal; liver enzymes AST,ALT / 5 times the upper limit of normal; total serum bilirubin / 1.5 times the upper limit of normal.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified