A PHASE IIb RANDOMIZED, CONTROLLED, PARTIALLY BLINDED CLINICAL TRIAL TO INVESTIGATE SAFETY, EFFICACY AND DOSE-RESPONSE OF BMS-986001 IN TREATMENT-NAÏVE HIV-1-INFECTED SUBJECTS, FOLLOWED BY AN OPEN-LABEL PERIOD ON THE RECOMMENDED DOSE.
- Registration Number
- PER-012-12
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 38
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.
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.AMUTATION PATTERNS ASSOCIATED WITH GENOTYPIC
RESISTANCE TO COMPONENTS OF THE STUDY REGIMEN
EFVRT: A98G, L100I, K101E/Q/R/P, K103, V106M, V108I, V 179D,
Y181C/I, Y188L, G190S/A/T, P225H, F227L, M23OI/L
TDFRT: M41L, K65R, D677N, K70R/E, INSERCION T69, L74V, L21W,
Y115F, Q151M, T215Y/F, K219Q/E/N
3TCRT: 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method