Phase 2 N=60 Randomized Triple-blind Treatment

Study to Evaluate a HIV Drug for the Treatment of HIV Infection

Infection, Human Immunodeficiency Virus · HIV Infections

Bottom Line

View on ClinicalTrials.gov: NCT01803074 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11 — -0.138; -0.567; -0.889; -1.279 Log10 copies per milliliter (c/mL)

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: BMS-955176 (Drug); Placebo matching with BMS-955176 (Drug); Atazanavir (Drug); Ritonavir (Drug); Tenofovir (Drug); Emtricitabine (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: ViiV Healthcare
Primary completion: Nov 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Plasma Log10 HIV-1 Ribonucleic Acid (RNA) Levels From Baseline to Day 11	-0.138; -0.567; -0.889; -1.279; -1.339; -1.326	—
SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) - Part A and C	3; 2.51; 3; 4; 3.5; 3	—
SECONDARY Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Related SAEs, Discontinuations Due to SAEs, Adverse Events (AEs), and Discontinuations Due to AEs During the Study	0; 0; 0; 0; 0; 0	—
SECONDARY Maximum Decline From Baseline in Log10 HIV-1 RNA - Part A and C	-0.498; -0.976; -1.115; -1.701; -1.555; -1.654	—
SECONDARY Maximum Decline From Baseline in Log10 HIV-1 RNA - Part B	-1.858; -2.202; -2.39; -2.228	—
SECONDARY Time to Maximum Decline in Log 10 HIV-1 RNA - Part A and C	168; 216; 203.9; 240.15; 204; 240.2	—
SECONDARY Time to Maximum Decline in Log 10 HIV-1 RNA - Part B	624; 636.05; 588; 636.05	—
SECONDARY Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part A and C	-21.8; 14.6; -70.1; -23.6; -43.8; -56.7	—
SECONDARY Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Counts - Part B	-133.2; -106.4; 33; -89; -442.8; -466.1	—
SECONDARY Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part A and C	2.33; 0.29; -1.29; 0.86; 2.13; 0.29	—
SECONDARY Percent Change From Baseline in Cluster of Differentiation (CD) 4+ and CD8+ Lymphocyte Percent - Part B	2.4; 3.25; 4.75; -0.75; -2.8; -6.25	—
SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) - Part B	5.01; 5.05; 5; 4.5; 5; 4.5	—
SECONDARY Maximum Observed Plasma Concentrations (Cmax) - Part A and C	79.376; 201.498; 349.466; 791.317; 1155.448; 1515.389	—
SECONDARY Plasma Concentration 24 Hours Post-Dose (C24) - Part A and C	34.946; 79.002; 154.5; 286.268; 482.349; 624.745	—
SECONDARY Maximum Observed Plasma Concentrations (Cmax) - Part B	695.596; 770.975; 1493.336; 1667.817; 1852; 3159.181	—
SECONDARY Plasma Concentration 24 Hours Post-Dose (C24) - Part B	462.312; 520.048; 899.364; 1099.313; 1163.177; 2010.679	—
SECONDARY Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC([Tau]) - Part A and C	1151.062; 2869.626; 5132.951; 10088.23; 17057.26; 21872.72	—
SECONDARY Area Under The Plasma Concentration - Time Curve Over the Dosing Interval (AUC[Tau]) - Part B	12147.23; 12954.8; 24478.35; 31406.32; 34225.08; 59915.72	—
SECONDARY Accumulation Index (AI): Part A and C	2.152; 1.674; 2.018; 1.856; 2.135; 1.854	—
SECONDARY Apparent Total Body Clearance: Part A and C	30.635; 32.246; 28.364; 29.005; 33.892; 45.267	—
SECONDARY Degree of Fluctuation (DF): Part A and C	0.766; 0.912; 0.758; 0.78; 0.779; 0.818	—
SECONDARY Average Observed Plasma Concentration at Steady State (Css-avg): Part A and C	113.326; 215.111; 489.507; 956.222; 1639.471; 1841.413	—
SECONDARY Plasma Half-life: Part A and C	32.134; 31.967; 27.382; 33.475; 29.171; 34.574	—
SECONDARY Number of Participants With Clinically Significant Grade 3/4 Laboratory Abnormalities From Baseline	0; 0; 0; 0; 0; 1	—
SECONDARY Number of Participants With Clinically Significant Changes in Heart Rate	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG)	1; 1; 1; 0; 0; 2	—
SECONDARY Number of Participants With Abnormal Changes in Physical Examination	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Clinically Significant Changes in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)	0; 0; 0; 0; 0; 0	—

Summary

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

Eligibility 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 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01803074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.