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

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ViiV Healthcare

Status and phase

Completed
Phase 2

Conditions

Infection, Human Immunodeficiency Virus
HIV Infections

Treatments

Drug: BMS-955176
Drug: Ritonavir
Drug: Tenofovir
Drug: Placebo matching with BMS-955176
Drug: Emtricitabine
Drug: Atazanavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01803074
206739
2012-004124-38 (EudraCT Number)
AI468-002 (Other Identifier)

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

107 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy 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:

  • 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

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

107 participants in 13 patient groups

Part A-Group 1: BMS-955176 (5 mg) or Placebo
Experimental group
Description:
BMS-955176 5 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Treatment:
Drug: Placebo matching with BMS-955176
Drug: BMS-955176
Part A-Group 2: BMS-955176 (10 mg) or Placebo
Experimental group
Description:
BMS-955176 10 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Treatment:
Drug: Placebo matching with BMS-955176
Drug: BMS-955176
Part A-Group 3: BMS-955176 (20 mg) or Placebo
Experimental group
Description:
BMS-955176 20 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Treatment:
Drug: Placebo matching with BMS-955176
Drug: BMS-955176
Part A-Group 4: BMS-955176 (40 mg) or Placebo
Experimental group
Description:
BMS-955176 40 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Treatment:
Drug: Placebo matching with BMS-955176
Drug: BMS-955176
Part B-Group 5: BMS-955176 + Atazanavir
Experimental group
Description:
BMS-955176 40 mg solution by mouth once daily for 28 days Atazanavir 2 x 200 mg capsules by mouth once daily for 28 days
Treatment:
Drug: Atazanavir
Drug: BMS-955176
Part B-Group 6: BMS-955176 + Atazanavir + Ritonavir
Experimental group
Description:
BMS-955176 40 mg solution by mouth once daily for 28 days Atazanavir 1 x 300 mg capsules by mouth once daily for 28 days Ritonavir 1 x 100 mg tablet by mouth once daily for 28 days
Treatment:
Drug: Atazanavir
Drug: Ritonavir
Drug: BMS-955176
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
Experimental group
Description:
Atazanavir 1 x 300 mg capsule by mouth once daily for 28 days Ritonavir 1 x 100 mg tablet by mouth once daily for 28 days Tenofovir 1 x 300 mg tablet by mouth once daily for 28 days Emtricitabine 1 x 200 mg capsule once daily for 28 days
Treatment:
Drug: Atazanavir
Drug: Emtricitabine
Drug: Tenofovir
Drug: Ritonavir
Part C-Group 8: BMS-955176 (40 mg) or Placebo
Experimental group
Description:
BMS-955176 40 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Treatment:
Drug: Placebo matching with BMS-955176
Drug: BMS-955176
Part A-Group 9: BMS-955176 (80 mg) or Placebo
Experimental group
Description:
BMS-955176 80 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Treatment:
Drug: Placebo matching with BMS-955176
Drug: BMS-955176
Part A-Group 10: BMS-955176 (120 mg) or Placebo
Experimental group
Description:
BMS-955176 120 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Treatment:
Drug: Placebo matching with BMS-955176
Drug: BMS-955176
Part A-Group 11 (Optional): BMS-955176 (≤120 mg) or Placebo
Experimental group
Description:
BMS-955176 ≤120 mg solution by mouth once daily for 14 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 14 days
Treatment:
Drug: Placebo matching with BMS-955176
Drug: BMS-955176
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
Experimental group
Description:
BMS-955176 80 mg solution by mouth once daily for 28 days Atazanavir 2 x 200 mg capsules by mouth once daily for 28 days
Treatment:
Drug: Atazanavir
Drug: BMS-955176
Part C-Group 13: BMS-955176 (120 mg) or Placebo
Experimental group
Description:
BMS-955176 120 mg solution by mouth once daily for 10 days OR Placebo matching with BMS-955176 0 mg solution by mouth once daily for 10 days
Treatment:
Drug: Placebo matching with BMS-955176
Drug: BMS-955176

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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