Study to Evaluate a HIV Drug for the Treatment of HIV Infection
NCT ID: NCT01803074
Last Updated: 2019-11-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
107 participants
INTERVENTIONAL
2013-04-04
2014-11-29
Brief Summary
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Detailed Description
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Gender: Both female and male participants for Parts A and C. Male participants for Part B.
HIV = Human Immunodeficiency Virus RNA = Ribonucleic acid
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Part A-Group 1: BMS-955176 (5 mg) or Placebo
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
BMS-955176
BMS-955176
Placebo matching with BMS-955176
Placebo matching with BMS-955176
Part A-Group 2: BMS-955176 (10 mg) or Placebo
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
BMS-955176
BMS-955176
Placebo matching with BMS-955176
Placebo matching with BMS-955176
Part A-Group 3: BMS-955176 (20 mg) or Placebo
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
BMS-955176
BMS-955176
Placebo matching with BMS-955176
Placebo matching with BMS-955176
Part A-Group 4: BMS-955176 (40 mg) or Placebo
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
BMS-955176
BMS-955176
Placebo matching with BMS-955176
Placebo matching with BMS-955176
Part B-Group 5: BMS-955176 + Atazanavir
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
BMS-955176
BMS-955176
Atazanavir
Atazanavir
Part B-Group 6: BMS-955176 + Atazanavir + Ritonavir
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
BMS-955176
BMS-955176
Atazanavir
Atazanavir
Ritonavir
Ritonavir
Part B-Group 7: Atazanavir+Ritonavir+Tenofovir+Emtricitabine
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
Atazanavir
Atazanavir
Ritonavir
Ritonavir
Tenofovir
Tenofovir
Emtricitabine
Emtricitabine
Part C-Group 8: BMS-955176 (40 mg) or Placebo
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
BMS-955176
BMS-955176
Placebo matching with BMS-955176
Placebo matching with BMS-955176
Part A-Group 9: BMS-955176 (80 mg) or Placebo
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
BMS-955176
BMS-955176
Placebo matching with BMS-955176
Placebo matching with BMS-955176
Part A-Group 10: BMS-955176 (120 mg) or Placebo
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
BMS-955176
BMS-955176
Placebo matching with BMS-955176
Placebo matching with BMS-955176
Part A-Group 11 (Optional): BMS-955176 (≤120 mg) or Placebo
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
BMS-955176
BMS-955176
Placebo matching with BMS-955176
Placebo matching with BMS-955176
Part B-Group 12: BMS-955176 (80 mg) + Atazanavir
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
BMS-955176
BMS-955176
Atazanavir
Atazanavir
Part C-Group 13: BMS-955176 (120 mg) or Placebo
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
BMS-955176
BMS-955176
Placebo matching with BMS-955176
Placebo matching with BMS-955176
Interventions
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BMS-955176
BMS-955176
Placebo matching with BMS-955176
Placebo matching with BMS-955176
Atazanavir
Atazanavir
Ritonavir
Ritonavir
Tenofovir
Tenofovir
Emtricitabine
Emtricitabine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
ViiV Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
ViiV Healthcare
Locations
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GSK Investigational Site
Berlin, , Germany
Countries
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References
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Hwang C, Schurmann D, Sobotha C, Boffito M, Sevinsky H, Ray N, Ravindran P, Xiao H, Keicher C, Huser A, Krystal M, Dicker IB, Grasela D, Lataillade M. Antiviral Activity, Safety, and Exposure-Response Relationships of GSK3532795, a Second-Generation Human Immunodeficiency Virus Type 1 Maturation Inhibitor, Administered as Monotherapy or in Combination With Atazanavir With or Without Ritonavir in a Phase 2a Randomized, Dose-Ranging, Controlled Trial (AI468002). Clin Infect Dis. 2017 Aug 1;65(3):442-452. doi: 10.1093/cid/cix239.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2012-004124-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI468-002
Identifier Type: OTHER
Identifier Source: secondary_id
206739
Identifier Type: -
Identifier Source: org_study_id
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