EUCTR2005-001895-11-IT
Active, not recruiting
Not Applicable
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
BRISTOL-M.SQUIBB0 sites1,200 target enrollmentJuly 17, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HIV-1 Infected Treatment Naive subjects
- Sponsor
- BRISTOL-M.SQUIBB
- Enrollment
- 1200
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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