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

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: HIV-1 Infection

Intervention: BMS-955176 (Drug); Placebo matching with BMS-955176 (Drug); Atazanavir (Drug); Ritonavir (Drug); Tenofovir (Drug); Emtricitabine (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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

Clinical Details

Official title: Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacodynamics, Safety and Pharmacokinetics of BMS-955176 (Double-Blinded) and BMS-955176 With Atazanavir +/- Ritonavir (Open-Labeled) in HIV-1 Infected Subjects

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change in plasma HIV-1 RNA levels from baseline (Day 1-predose) on Day 11 with monotherapy

Secondary outcome:

Safety based on frequency of Adverse events (AEs), serious AEs, discontinuations due to AEs, findings of marked abnormalities in vital signs, clinical laboratory tests, ECG readings and physical examinations

Time course of the change from baseline in plasma log10 HIV-1 RNA levels and the time of maximum decrease during the 10-day monotherapy and combination therapy of BMS-955176 with Atazanavir (ATV) +/- Ritonavir (RTV)

Change from baseline in CD4+ and CD8+ lymphocyte counts and percentages following monotherapy and combination therapy of BMS-955176 with ATV +/- RTV in HIV-1 infected subjects

Maximum observed plasma concentration (Cmax) of BMS-955176

Observed concentration at 24 hours postdose (C24) of BMS-955176

Time of maximum observed plasma concentration (Tmax) of BMS-955176

Trough observed plasma concentration (Ctrough) of BMS-955176

Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-955176

Accumulation Index (AI), calculated as ratio of AUC(TAU) at steady state to AUC(TAU) after the first dose of BMS-955176

Apparent total body clearance (CLT/F) of BMS-955176

Terminal Plasma half-life (T-Half)-after last dose only of BMS-955176

Degree of Fluctuation (DF), calculated as steady state (Cmax-C24) / (AUC(TAU) / 24) of BMS-955176

Average steady-state plasma concentration (Css-av), calculated as AUC(TAU) / TAU of BMS-955176

Detailed 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

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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:

- 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

Locations and Contacts

Local Institution, Berlin 10117, Germany

Local Institution, Pretoria, Gauteng 0087, South Africa

Additional Information

BMS Clinical Trial Information

BMS clinical trial educational resource

Investigator Inquiry form

FDA Safety Alerts and Recalls

Starting date: March 2013
Last updated: February 6, 2015

Page last updated: August 23, 2015

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