Study to Evaluate a HIV Drug for the Treatment of HIV Infection
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
The primary purpose of this study is to study the safety and tolerability of a HIV drug and to evaluate a decrease of HIV-1 virus level in blood after treatments in HIV-1 infected patients
Full description
Masking: Open-Part B. Double Blind-Parts A and C
Gender: Both female and male participants for Parts A and C. Male participants for Part B.
HIV = Human Immunodeficiency Virus RNA = Ribonucleic acid
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
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Age 18-55 years inclusive
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Men and women: (Parts A and C); men only (Part B)
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Women of childbearing potential (WOCBP) must not be pregnant and nursing
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BMI: 18.0-35.0 kg/m2
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Subjects are infected with HIV-1 (clades B or C) and meet following criteria at the screening:
i) Plasma HIV-1 RNA ≥5,000 copies/mL; ii) Antiretroviral treatment naive (defined as <1 week of ARV treatment) or ART-experienced (protease inhibitor and/or maturation inhibitor naive); iii) Subjects are not eligible for HIV-1 treatment based on the United States Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents or have declined initiation of cART iv) CD4+ lymphocyte measurement ≥200 cells/μL; v) In Parts A and B, all subjects are infected with HIV-1 clade B vi) In Part C, all subjects are infected with HIV-1 clade C
Exclusion Criteria:
- History of genotypic and/or phenotypic drug resistance testing showing resistance to protease inhibitors
- Any significant acute or chronic medical illness which is not stable or is not controlled with medication or not consistent with HIV-1 infection
- Receive antiretroviral treatment within 12 weeks prior to screening
- Currently co-infected with hepatitis C or hepatitis B
- Previously received an HIV maturation inhibitor or HIV protease inhibitor
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Acute diarrhea lasting ≥1 day, within 3 weeks prior to randomization
- Subjects with history of Gilbert's syndrome
- Subjects previously received an HIV maturation inhibitor or HIV protease inhibitor
- 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
- Patients 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 maturation inhibitor and/or ATV
- Any gastrointestinal surgery that could impact upon the absorption of study drug
- Smoking >10 cigarettes per day
- PR ≥210 msec; QRS ≥120 msec; QT ≥500 msec; and QTcF ≥470 msec for women and ≥450 msec for men
- Evidence of second or third degree heart block prior to study drug
- Absolute Neutrophil Count <(ANC) 0.7 x lower limit of normal (LLN)
- Hemoglobin <0.8 x LLN
- Alanine aminotransferase (ALT) >1.25 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) >1.25 x ULN
- Total Bilirubin >1.25 x ULN
- Creatinine clearance <60 mL/mim
- Positive urine screen for drugs of abuse without a valid prescription (subjects positive for cannabinoids and/or amphetamines will be included)
- Positive blood screen for hepatitis C virus (HCV) RNA, hepatitis B surface antigen (consistent with active or chronic hepatitis B), or HIV-2 antibody
- History of any significant drug allergy
Trial design
Primary purpose
Allocation
Interventional model
Masking
107 participants in 13 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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