A PHASE IIB RANDOMIZED, CONTROLLED, PARTIALLY-BLINDED TRIAL TO INVESTIGATE SAFETY, EFFICACY AND DOSE-RESPONSE OF BMS-663068 IN TREATMENT-EXPERIENCED HIV-1 SUBJECTS, FOLLOWED BY AN OPEN-LABEL PERIOD ON THE RECOMMENDED DOSE
- Registration Number
- PER-067-11
- Lead Sponsor
- ViiV Healthcare UK Limited,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 50
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 < 1 WEEK PRIOR EXPOSURE)
F) SCREENING GENOTYPE/PHENOTYPE INDICATING SUSCEPTIBILITY TO ATV/R, RAL AND TDF;
G) SCREENING PHENOSENSE ® ENTRY INDICATING BMS-626529 IC50 <0.1 µM;
H) CD4+ T-CELL COUNT > 50 cells/mm³
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method