Safety, Efficacy and Dose response study of BMS-986001 in subjects with HIV-1 Infection who are treatment-naive.

• Conditions: Human Immunodeficiency Virus type 1 (HIV-1) infection; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2011-003329-89-DE
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-07
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1) Signed Written Informed Consent:
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) Men and women at least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements 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 antiretroviral drug,
d) CD4 + T-cell count > 200 cells/mm3.
3) Age and Reproductive Status:
a) Women of childbearing potential (WOCBP) and men must be using at least 2 acceptable methods of contraception, including at least 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,
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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1) Target Disease Exceptions:
a) History of genotypic and/or phenotypic 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:
EFV RT: A98G, L100I, K101E/Q/R/P, K103N, V106M, V108I, V179D, Y181C/I, Y188L, G190S/A/T, P225H, F227L, M230I/L;
TDF RT: M41L, K65R, D67N, K70R/E, T69 insertion, L74V, L210W, 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, M46I/L, I47V/A, G48V, I50L, I54M/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 drug,
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 of clinically relevant cardiac disease, defined by presence of arrhythmias, ischemic disease, or a conduction abnormality including
2nd/3rd degree atrioventricular block (AVB), or any cardiac abnormality deemed clinically relevant by investigator,
d) Personal or family history of long QT syndrome,
e) History of seizures or other clinically relevant CNS disorders,
f) History of diagnosed and uncontrolled mental illness,
g) History of suicidal ideation or attempt,
h) History of Idiopathic Thrombocytopenia Purpura or clinically relevant diagnosis of thrombocytopenia,
i) Active alcohol or substance use which in the investigator’s opinion is sufficient,
to prevent adequate adherence with study therapy or make participation in the study not in the best interest of the subject.
3) Physical and Laboratory Test Findings:
a) Liver enzymes (ALT/AST) > 3 times the upper limit of normal,
b) Alkaline phosphatase > 5 times the upper limit of normal,
c) Creatinine clearance < 60 cc/min,
d) Hemoglobin < 8.0 g/dL,
e) Platelets < 75,000 cells/mm3,
f) Positive blood screen for HBsAg,
g) Positive blood screen for HCV Ab and HCV RNA,
h) Confirmed QT value > 500 msec at Screening or Day -1,
i) Confirmed QTc value > 470 msec for women and > 450 msec for men at Screening or Day -1,
j) Confirmed PR Interval > 260 msec (severe first degree AV block),
k) Confirmed second or third degree heart block at Screening or Day -1,
4) Allergies and Adverse Drug Reaction,
a) History of allergy to TDF, EFV, or 3TC,
b) History of clinically relevant severe drug reaction (such as anaphylaxis or hepatotoxicity.
5) Other Exclusion Criteria:
a) Prisoners or subjects who are involuntarily incarcerated
b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness,
c) Contraindications to any of the study drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified