A Phase 1, Open Label, Dose-escalation Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 3BNC117

Completed · Phase 1

Conditions studied: Healthy, HIV

In brief

The proposed study is a first-in-man phase I study that aims to evaluate the safety, tolerability and pharmacokinetics of 3BNC117 in HIV-infected and HIV-uninfected subjects, and its antiretroviral activity in HIV-infected subjects.

Key facts

Study ID

NCT02018510

Run by

Rockefeller University

People needed

49

Starts

2014-01-01

Expected to finish

2016-01-01

Last updated by the study team

2016-12-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Group 1 (HIV-uninfected):
• 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.

You may not qualify if…

• Group 1 (HIV-uninfected):
• 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:

Where it is running

• 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

Full record on ClinicalTrials.gov

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