MULTICENTER, DOUBLE-BLIND, RANDOMIZED, DETERMINATION STUDY OF THE RANGE OF DOSE TO COMPARE THE SAFETY AND ACTIVITY OF MK-0518 PLUS TENOFOVIR AND LAMIVUDINE (3TC) COMPARED TO EFAVIRENZ PLUS TENOFOVIR AND LAMIVUDINE (3TC) IN PATIENTS INFECTED WITH HIV NOT SUBMITTED TO ART- EXTENSION STUDY
Not Applicable
- Conditions
- -B24 Unspecified human immunodeficiency virus [HIV] diseaseUnspecified human immunodeficiency virus [HIV] diseaseB24
- Registration Number
- PER-054-08
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
-Patients who complete the original study until Week 144 will be able to continue with this second period of study extension (the visit 14 days after therapy is not necessary in the case of patients entering the extension).
-All patients must provide informed consent to
Participate in the extension.
Exclusion Criteria
NA
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:They will be presented in tables by treatment group with MK-0518 in a dose of 400 mg b.i.d. and efavirenz: (1) at least one adverse event; (2) an adverse event related to the drug; (3) a serious adverse event; (4) serious adverse events related to the drug, (5) adverse events that lead to discontinuation.<br>Measure:Proportion of patients presenting types of clinical or laboratory adverse events during the 96-week extension, for a total of 240 weeks<br>Timepoints:240 weeks<br>;<br>Outcome name:Changes from baseline in plasma HIV RNA (log10 copies / mL, as measured by the AMPLICOR HIV-1 Monitor ™ Test) and CD4 cell count will also be summarized per treatment group at each assessment point up to Week 240<br>Measure:Proportion of patients who reached plasma HIV RNA levels below the threshold of reliable quantification of the AMPLICOR HIV-1 Monitor Test<br>Timepoints:240 weeks<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Measurement of RNA levels using the AMPLICOR HIV-1 Monitor Standard assay<br>Measure:Proportion of patients with HIV RNA levels below the quantification threshold for the AMPLICOR HIV-1 Monitor Standard trial (<400 copies / mL, Version 1.5)<br>Timepoints:Week 240<br>;<br>Outcome name:Measurement of plasma RNA levels<br>Measure:Change from baseline in HIV RNA in plasma (log10 copies / mL)<br>Timepoints:240 weeks<br>;<br>Outcome name:Measurement of CD4 cell count<br>Measure:Change with respect to the baseline in the CD4 cell count.<br>Timepoints:240 weeks<br>