None listed
Conditions
Interventions
APPROXIMATELY 250 TREATMENT-EXPERIENCED SUBJECTS WILL BE RANDOMIZED 1:1:1:1:1 TO FIVE DIFFERENT TREATMENT GROUPS OF THE STUDY: FOUR GROUPS EACH WITH A DISTINCT DOSE OF BMS-663068, AND A REFERENCE GROU
0.0013 µM).
THE STUDY CONSISTS OF AN ELECTIVE MONOTHERAPY SUBSTUDY AND THE PRIMARY STUDY DIVIDED INTO STAGE 1, STAGE 2, FOLLOWED BY A POST-DOSING FOLLOW-UP PHASE.
THOSE WHO RANDOMIZE INTO THE R
Sponsors
ViiV Healthcare UK Limited,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) SIGNED WRITTEN INFORMED CONSENT A) FREELY GIVEN INFORMED CONSENT MUST BE OBTAINED FROM SUBJECTS PRIOR TO CLINICAL TRIAL PARTICIPATION, INCLUDING INFORMED CONSENT FOR ANY SCREENING PROCEDURES CONDUCTED TO ESTABLISH SUBJECT ELIGIBILITY FOR THE STUDY. 2) TARGET POPULATION A) PLASMA HIV-1 RNA ≥ 1000 copies/ml AT SCREENING; B) MEN AND WOMEN; C) AT LEAST 18 YEARS OF AGE, (OR MINIMUM AGE AS DETERMINED BY LOCAL REGULATORY OR AS LEGAL REQUIREMENTS DICTATE, WHICHEVER IS HIGHER); D) ANTIRETROVIRALS TREATMENT-EXPERIENCED, DEFINED AS CURRENT OR PREVIOUS EXPOSURE TO AT LEAST 1 WEEK AT LEAST 1 ANTIRETROVIRAL DRUG; E) NAIVE TO TREATMENT WITH ANY INTEGRASE INHIBITOR (DEFINED AS 50 cells/mm³
Exclusion criteria
Exclusion criteria: 1) TARGET DISEASE EXCEPTIONS A) HISTORY OF GENOTYPIC RESISTANCE TO ANY COMPONENT OF STUDY REGIMEN (TDF, ATV, RAL); B) SGREENING HIV-1 GENOTYPE AND/OR PHENOTYPE SHOWING RESISTANCE; THE PHENOTYPIC RESISTANCE TO A DRUG IS DEFINED AS A FOLD CHANGE (ie, RATIO OF THE 50% INHIBITORY CONCENTRATION [IC50] OF THE CLINICAL ISOLATED TO THE IC50 OF THE REFERENCE STRAIN) GREATER THAN THE CUT-OFF FOR REDUCED SUSCEPTIBILITY. THE FOLLOWING TABLE DISPLAYS CUT-OFFS USED BY MONOGRAM BIOSCIENCES, INC., CA TO DETERMINE REDUCED SUSCEPTIBILITY TO EACH DRUG. ANY SAMPLE WITH FC GREATER THAN CUTT-OFF FOR A DRUG WILL BE CONSIDERED RESISTANT TO THAT PARTICULAR DRUG (SEE TABLE 3.3.2-2). RAL ONLY HAS A BIOLOGICAL CUT-OFF (BCO). ANY SAMPLE FROM A SUBJECT WITH BCO> 1.5 FOR RAL WILL BE CONSIDERED PHENOTYPICALLY RESISTANT TO RAL.
Countries
Argentina, Colombia, Germany, Mexico, Peru, Romania, Russian Federation, South Africa, Spain, United States
Contacts
Public ContactCECILIA CANALES
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed