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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:
Age 18-55 years inclusive
Men and women: (Parts A and C); men only (Part B)
Women of childbearing potential (WOCBP) must not be pregnant and nursing
BMI: 18.0-35.0 kg/m2
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:
Primary purpose
Allocation
Interventional model
Masking
107 participants in 13 patient groups
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Data sourced from clinicaltrials.gov
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