A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117
NCT ID: NCT02018510
Last Updated: 2016-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
2014-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Group 1A
HIV-uninfected individuals
1 mg/kg, single dose IV administration of 3BNC117
1 mg/kg, single dose IV administration of 3BNC117
1 mg/kg, single dose IV administration of 3BNC117
Groups 1B
HIV-uninfected individuals 3 mg/kg, single dose IV administration of 3BNC117
3 mg/kg, single dose IV administration of 3BNC117
3 mg/kg, single dose IV administration of 3BNC117
Group 1C
HIV-uninfected individuals 10 mg/kg, single dose IV administration of 3BNC117
10 mg/kg, single dose IV administration of 3BNC117
10 mg/kg, single dose IV administration of 3BNC117
Group 1D
HIV-uninfected individuals 10 mg/kg, two doses IV of 3BNC117
10 mg/kg, two doses IV of 3BNC117
10 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12
Group 1E
HIV-uninfected individuals 30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
Group 1F
HIV-uninfected individuals 30 mg/kg, two doses IV of 3BNC117
30 mg/kg, two doses IV of 3BNC117
30 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12
Group 2A
HIV-infected individuals on or off ART
1 mg/kg, single dose IV administration of 3BNC117
1 mg/kg, single dose IV administration of 3BNC117
1 mg/kg, single dose IV administration of 3BNC117
Group 2B
HIV-infected individuals on or off ART 3 mg/kg, single dose IV administration of 3BNC117
3 mg/kg, single dose IV administration of 3BNC117
3 mg/kg, single dose IV administration of 3BNC117
Group 2C
HIV-infected individuals on or off ART 10 mg/kg, single dose IV administration of 3BNC117
10 mg/kg, single dose IV administration of 3BNC117
10 mg/kg, single dose IV administration of 3BNC117
Group 2D
HIV-infected individuals on or off ART 30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
Group 2E
HIV-infected individuals off ART, VL 2,000-100,000 copies/ml 30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
Group 3
HIV-infected individuals off ART, VL \< 2,000 copies/ml 30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
Group 4
HIV-infected individuals on ART, VL \< 100,000 copies/ml 30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
Group 5A
HIV-infected individuals on ART, VL \< 20 copies/ml 10 mg/kg, single dose IV administration of 3BNC117
10 mg/kg, single dose IV administration of 3BNC117
10 mg/kg, single dose IV administration of 3BNC117
Group 5B
HIV-infected individuals on ART, VL \< 20 copies/ml 30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
Interventions
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1 mg/kg, single dose IV administration of 3BNC117
1 mg/kg, single dose IV administration of 3BNC117
3 mg/kg, single dose IV administration of 3BNC117
3 mg/kg, single dose IV administration of 3BNC117
10 mg/kg, single dose IV administration of 3BNC117
10 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
30 mg/kg, single dose IV administration of 3BNC117
10 mg/kg, two doses IV of 3BNC117
10 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12
30 mg/kg, two doses IV of 3BNC117
30 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12
Eligibility Criteria
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Inclusion Criteria
* Adult males and females, age 18 to 65
* Amenable to HIV risk reduction counseling and agrees to maintaining behavior consistent with low risk of HIV exposure;
* If a sexually active male or female, participating in sexual activity that could lead to pregnancy, agrees to use an effective method of contraception throughout the study.
* Groups 2-5 (HIV-infected):
* Age 18 to 65
* HIV infection confirmed by ELISA and immunoblot
* Groups 2A-D - on ART with HIV-1 plasma RNA levels below 100,000 copies/ml, or off ART for at least 8 weeks with HIV-1 plasma RNA level between 2,000-100,000 copies/ml by standard assays on 2 occasions at least 1 week apart;
* Group 2E - Untreated HIV-infected (not on ART for at least 8 weeks): HIV-1 RNA plasma levels between 2,000 - 100,000 copies/ml;
* Group 3 - Untreated HIV controllers (not on ART for at least 8 weeks): HIV-1 RNA plasma level of \< 2,000 copies/ml by standard assays, on 2 occasions, at least 1 week apart, and ART-naive.
* Group 4 - ART treated with HIV-1 RNA plasma level of \> 20 copies/ml by standard assays on 2 occasions, at least 1 week apart, while on combination antiretroviral therapy;
* Groups 5A and 5B - ART treated with HIV-1 RNA plasma level of \< 20 copies/ml by standard assays on 2 occasions, at least 1 week apart, while on combination antiretroviral therapy;
* Current CD4 cell count \> 300 cells/µl
* If sexually active male and female, participating in sexual activity that could lead to pregnancy, agrees to use an effective method of contraception throughout the study.
Exclusion Criteria
* Confirmed HIV-1 or HIV-2 infection;
* History of immunodeficiency or autoimmune disease; use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months;
* Any clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation;
* Within the 12 months prior to enrollment, the volunteer has a history of sexually transmitted disease;
* Hepatitis B (surface antigen, HbsAg) or hepatitis C (HCV antibodies);
* Laboratory abnormalities in the parameters listed below:
* Absolute neutrophil count ≤ 2,000
* Hemoglobin ≤ 12 gm/dL if female; ≤ 13.5 gm/dL if male
* Platelet count ≤ 140,000
* ALT ≥ 1.25 x ULN
* AST ≥ 1.25 x ULN
* Total bilirubin ≥ 1.1 ULN
* Creatinine ≥ 1.1 x ULN
* Coagulation parameters (PT, PTT, INR) ≥ 1.1 x ULN
* Pregnancy or breastfeeding;
* Any vaccination within 14 days prior to 3BNC117 administration;
* Receipt of any experimental HIV vaccine in the past or monoclonal antibody therapy of any kind in the past;
* Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
* Groups 2-5 (HIV-infected):
* History of AIDS-defining illness
* History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months;
* Any clinically significant acute or chronic medical condition, other than HIV infection, that in the opinion of the investigator would preclude participation;
* Hepatitis B (surface antigen, HbsAg) or hepatitis C (HCV antibodies);
* Laboratory abnormalities in the parameters listed below:
* Absolute neutrophil count ≤ 1,300
* Hemoglobin ≤ 10 gm/dL
* Platelet count ≤ 125,000
* ALT ≥ 2.0 x ULN
* AST ≥ 2.0 x ULN
* Total bilirubin ≥ 1.1 ULN
* Creatinine ≥ 1.1 x ULN
* Coagulation parameters ≥ 1.1 x ULN;
* Current antiretroviral regimen includes either maraviroc or enfuvirtide;
* Pregnancy or breastfeeding;
* Any vaccination within 14 days prior to 3BNC117 administration;
* Receipt of any experimental HIV vaccine or monoclonal antibody therapy of any kind in the past;
* Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.
18 Years
65 Years
ALL
Yes
Sponsors
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Weill Medical College of Cornell University
OTHER
Brigham and Women's Hospital
OTHER
University of Cologne
OTHER
Rockefeller University
OTHER
Responsible Party
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Principal Investigators
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Marina Caskey, MD
Role: PRINCIPAL_INVESTIGATOR
Rockefeller Univesrity
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
The Rockefeller University
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
University of Cologne
Cologne, , Germany
Countries
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References
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Schoofs T, Klein F, Braunschweig M, Kreider EF, Feldmann A, Nogueira L, Oliveira T, Lorenzi JC, Parrish EH, Learn GH, West AP Jr, Bjorkman PJ, Schlesinger SJ, Seaman MS, Czartoski J, McElrath MJ, Pfeifer N, Hahn BH, Caskey M, Nussenzweig MC. HIV-1 therapy with monoclonal antibody 3BNC117 elicits host immune responses against HIV-1. Science. 2016 May 20;352(6288):997-1001. doi: 10.1126/science.aaf0972. Epub 2016 May 5.
Other Identifiers
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MCA-0835
Identifier Type: -
Identifier Source: org_study_id