EUCTR2005-001895-11-AT
Active, not recruiting
Not Applicable
A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/ritonavirwith Lopinavir/ritonavir, Each in Combination with Fixed Dose Tenofovir-Emtricitabinein HIV-1 Infected Treatment Naive Subjects.Revised Protocol 01: incorporates amendment 03.Pharmacogenetics Blood Sample Amendment 01, version 1.0, dated 21-Sep-05; andMetabolic Pharmacogenetics Substudy Amendment 02, version 1.0, dated 21-Sep-05
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Bristol-Myers Squibb International Corporation
- Enrollment
- 1200
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Provide written informed consent and assess whether the subject is capable of reading and comprehending the informed consent;
- •2\) Qualifying plasma HIV RNA \= 5000 c/mL obtained at screening;
- •3\) Men and women, ages 18 years and older (or minimum age as determined by local regulatory or as legal requirements dictate).
- •4\) Women of childbearing potential (WOCBP) must be using an adequate method of
- •contraception to avoid pregnancy throughout the study and for up to 8 weeks after the study in such a manner that the risk of pregnancy is minimized. Both females and males must utilize effective barrier contraception.
- •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
Exclusion Criteria
- •1\) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the study;
- •2\) WOCBP using a prohibited contraceptive method (see Protocol Appendix 8\);
- •3\) Women who are pregnant or breastfeeding;
- •4\) Women with a positive pregnancy test on enrollment or prior to study drug administration;
- •5\) Presence of a newly diagnosed HIV\-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment;
- •6\) Suspected primary (acute) HIV infection;
- •7\) Any antiretroviral therapy within 30 days prior to screening
- •8\) Prior antiretroviral therapy \= 1 week. In the specific setting of antiretroviral treatment for reduction of risk of mother\-to\-child transmission, the following criteria will apply:
- •\= 6 weeks of triple antiretroviral therapy (3 drugs of any class)
- •\= 4 weeks of dual antiretroviral therapy (2 drugs of any class)
Outcomes
Primary Outcomes
Not specified
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A 96 Week Study Comparing the Antiviral Efficacy and Safety of Atazanavir/ritonavirwith Lopinavir/ritonavir, Each in Combination with Fixed Dose Tenofovir-Emtricitabinein HIV-1 Infected Treatment Naive Subjects.Revised Protocol 01: Incorporates changes from Amendment 03.Pharmacogenetics Blood Sample Amendment 01, version 1.0, dated 21-Sep-05; andMetabolic Pharmacogenetics Substudy Amendment 02, version 1.0, dated 21-Sep-05EUCTR2005-001895-11-ESBristol-Myers Squibb International Corporation1,200
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