Randomized, Open label, Multiple-Dose Study to Evaluate the Pharmacodynamics,Safety and Pharmacokinetics of BMS-663068 in HIV-1 Infected Subjects
- Conditions
- HIV-1MedDRA version: 12.0Level: LLTClassification code 10020192Term: HIV-1
- Registration Number
- EUCTR2009-013657-14-DE
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 50
1) Signed Written Informed Consent
a) The signed informed consent form
2) Target Population
a) Clade B HIV-1 infected subjects meeting the following criteria at the screening visit (within 35 days of enrollment):
i) Plasma HIV RNA level = 5,000 copies/mL (may be repeated for confirmation)
ii) CD4+ lymphocyte measurement = 200 cells/µL (may be repeated for confirmation)
iii) Antiretroviral naive or experienced (ARV naive is defined by: No prior antiretroviral therapy of = 1 week)
iv) Off all antiretroviral therapy with HIV activity for > 8 weeks
v) Have not previously received an HIV attachment inhibitor
b) Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI = weight (kg)/ [height(m)]2
c) Not currently co-infected with HCV or HBV
3) Age and Sex
a) Men and women, = 18 years of age
Women of childbearing potential (WOCBP) must be using an adequate method of contraception (generally defined as two separate forms of contraception, one of
which must be an effective barrier method (eg, condom with spermicide), to avoid
pregnancy throughout the study and for up to 12 weeks after the last dose of
investigational product in such a manner that the risk of pregnancy is minimized.
WOCBP include any female who has experienced menarche and who has not
undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation,
or bilateral oophorectomy) or is not postmenopausal. Post menopause is defined
as:
• Amenorrhea = 12 consecutive months without another cause or
• For women with irregular menstrual periods and on hormone replacement
therapy (HRT), a documented serum follicle stimulating hormone (FSH) level
> 35 mIU/mL
Women who are using oral contraceptives, other hormonal contraceptives (vaginal
products, skin patches, or implanted or injectable products), or mechanical
products such as an intrauterine device or barrier methods (diaphragm, condoms,
spermicides) to prevent pregnancy, or are practicing abstinence or where their
partner is sterile (eg, vasectomy) should be considered to be of childbearing
potential.
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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
-WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy generally defined as two effective forms of contraception) for the entire study period and for up to 12w after the last dose of IP
-WOCBP using a prohibited contraceptive method including oral, injectable, or implantable hormonal contraceptive agent within 12w of enrollment.
-Women who are pregnant or breastfeeding
-Women with a pos pregnancy test on enrollment or prior to IP admin
-Sexually active fertile men not using effective birth control (generally defined as two effective forms of contraception) during study participation and for at least 12w after the last dose of IP if their partners are WOCBP
- Any significant acute or chronic medical illness which is not stable or is not controlled with med or not consistent with HIV infection
-Current or recent (within 3m) GI disease that, in the opinion of the inv or Medical Monitor, may impact on drug absorption and/or put the subject at risk for GI tract irritation and/or bleeding. Exclusionary diseases include, but are not limited to GI ulcers, esophageal or gastric varicies, or hematochezia
-Acute diarrhea lasting = 1 day, within 3w prior to randomization. Diarrhea will be defined as the passage of liquid feces and/or a stool frequency greater than 3 times/d
-Any major surgery within 4w of study drug admin
-Any gastrointestinal surgery that could impact upon the absorption of study drug
-Donation of blood or plasma to a blood bank or in a clinical study (except a Screening visit or follow up visit of less than 50 mL) within 4w of study drug admin
-Blood transfusion within 4w of study drug admin
-Inability to tolerate oral med
-Inability to be venipunctured and/or tolerate venous access
-A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes
- A personal or family history of long QT syndrome Subjects who are unwilling to practice adequate infection protection during and after study participation to minimize potential for spread of HIV infection, including HIV which may have developed resistance to HIV attachment inhibitors. Such protections could include, but are not limited to behaviors to minimize potential for exposure to the subjects’ infected bodily fluid or initiation of HAART therapy if indicated and recommended by a physician.
Recent (within 6m) drug or alcohol abuse as defined in DSM IV, Diagnostic Criteria for Drug and Alcohol Abuse (Appendix 2)
Any other medical, psychiatric and/or social reason which, in the opinion of the Inv, would make the candidate inappropriate for participation in this study
Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations or not consistent with the subject’s degree of HIV infection
Confirmed QT value >500 msec at screening or D-1
Confirmed QTc value >470 msec for women and >450 msec for men at screening or D-1
Evidence of second or third degree heart block at screening or D-1, confirmed by repeat ECG
Pos urine screen for drugs of abuse at either Screening or D-1 without a valid prescription (subjects positive for cannabinoids and amphetamines will be included, unless excluded by exclusion criteria 2m)
Pos blood screen for hepatitis B surface antigen
Pos blood screen for hepatitis C antibody and hepatitis C RNA
Any of the following screening or D
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method