None listed
Conditions
Interventions
APPROXIMATELY 300 TREATMENT-NAIVE SUBJECTS WILL BE RANDOMIZED 2:2:2:3 (67 PER BMS-986001 TREATMENT GROUP AND 100 IN THE REFERENCE GROUP) TO FOUR DIFFERENT TREATMENT GROUPS: THREE GROUPS, EACH WITH A D
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
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, INCLUIDING INFORMED CONSENT FOR ANY SCREENING PROCEDURES CONDUCTED TO ESTABLISH SUBJECT ELIGIBILITY FIR THE STUDY. 2. TARGET POPULATION A) MEN AND WOMEN AT LEAST 18 YEARS OF AGE, (OR MINIMUM AGE AS DETERMINED BY LOCAL REGULATORY OR AS LEGAL REQUERIMENTS DICTATE, WHICHEVER IS HIGHER). B) PLASMA HIV-1 RNA > 5000 COPIES/ML. C) ANTIRETROVIRAL TREATMENT-NAIVE; DEFINED AS NO CURRENT OR PREVIOUS EXPOSURE TO > 1 WEEK OF AN ANRETROVIRAL DRUG. D) CD4 + T-CELL COUNT > 200 CELLS/mm3. 3. AGE AND REPRODUCTIVE STATUS A) WOMEN OF CHILDBEARING POTENCIAL (WOCBP) AND MEN BE USING AL TEAST 2 ACCEPTABLE METHODS OF CONTRACEPTION, INCLUIDING AT LESTA ONE BARRIER METHOD, TO AVOID PREGNANCY THROUGHOUT THE STUDY, FOR UP TO 12 WEEKS AFTER THE LAST DOSE OF INVESTIGATIONAL PRODUCT IN SUCH A MANNER THAT THE RISK OF PREGNANCY IS MINIMIZED. SEE SECTION 3.3.3 FOR THE DEFINITION OF WOCBP. B) WOCBP MUST HAVE A NEGATIVE SERUM OR URINE PREGNANCY TEST (MINIMUM SENSITIVITY 25 IU/L OR EQUIVALENT UNITS OF HCG) WITHIN 24 HOURS PRIOR TO THE START OF INVESTIGATIONAL PRODUCT. C) WOMEN MUST NOT BE BREASTFEEDING. D) SEXUALLY ACTIVE FERTILE MEN MUST USE EFFECTIVE BIRTH CONTROL IF THEIR PARTNERS ARE WOCBP.
Exclusion criteria
Exclusion criteria: 1. TARGET DISEASE EXCEPTIONS A) HISTORY OF GENOTYPIC DRUG RESISTANCE TESTING SHOWING RESISTANCE TO EFV, TDF, OR 3TC. B) SCREENING HIV-1 GENOTYPIC DRUG RESISTANCE TESTING SHOWING RESISTANCE TO EFV, TDF, OR 3TC, AS DEFINED BY THE PRESENCE OF ANY IN THE FOLLOWING, TABLE 3.3.2.A: TABLA 3.3.2.A MUTATION PATTERNS ASSOCIATED WITH GENOTYPIC RESISTANCE TO COMPONENTS OF THE STUDY REGIMEN EFV RT: A98G, L100I, K101E/Q/R/P, K103, V106M, V108I, V 179D, Y181C/I, Y188L, G190S/A/T, P225H, F227L, M23OI/L TDF RT: M41L, K65R, D677N, K70R/E, INSERCION T69, L74V, L21W, Y115F, Q151M, T215Y/F, K219Q/E/N 3TC RT: M184V/I, K65R C) SCREENING HIV-1 GENOTYPIC DRUG RESISTANCE TESTING SHOWING PRIMARY PROTEASE INHIBITOR RESISTANCE MUTATIONS AS DEFINED BY THE PRESENCE OF ANY OF THE FOLLOWING: PR:D30N, M461/L, I47V/A, G48, I50L, I554M/L, Q58E, T74P, L76V, V82A/F/L/T/S, N83D, I84V, N88S, L90M. 2. MEDICAL HISTORY AND CONCURRENT DISEASES A) ANY GASTROINTESTINAL DISEASE OR SURGICAL PROCEDURE THAT MAY IMPACT ABSORPTION OF STUDY DROUG. B) PRESENCE OF A NEWLY DIAGNOSED HIV-RELATED OPPORTUNISTIC INFECTION (OI) OR ANY MEDICAL CONDITION REQUIRING ACUTE THERAPY AT THE TIME OF ENROLLMENT; SUSPECTED PRIMARY (ACUTE) HIV INFECTION. C) HISTORY OF OR CURRENT PRESENCE CLINICALLY RELEVANT CARDIAC DISEASE, DEFINED BY PRESENCE OF ARRHYTHM
Countries
Argentina, Australia, Canada, Chile, Colombia, France, Hungary, Mexico, South Africa, Spain, Thailand
Contacts
Public ContactNancy Chacon
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed