3BNC117 and 10-1074 in HIV Uninfected Adults

• Status: Completed
• Trial end date: 2018-01-09
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1 clinical trial to evaluate the safety and pharmacokinetics of the highly neutralizing anti-human immunodeficiency virus-1 monoclonal antibodies 3BNC117 and 10-1074, when given in combination, in human immunodeficiency virus (HIV)-uninfected individuals. This study is intended to support the development of the combination of 3BNC117 and 10-1074 mAbs for use as prophylaxis against HIV infection in healthy HIV-uninfected individuals at risk for HIV infection.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rockefeller University
• Treatments: Antibodies; Antibodies, Monoclonal; Antineoplastic Agents, Immunological; Immunoglobulins

Criteria

Inclusion Criteria:

• Males and females, age 18 to 65.

• Amenable to HIV risk reduction counseling and agrees to maintain behavior consistent with low risk of HIV exposure.

• If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use two effective methods of contraception (i.e. condom with spermicide, diaphragm with spermicide, hormone-eluting IUD, hormone-based contraceptive with condom) for the duration of 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 (such as autoimmune diseases) that in the opinion of the investigator would preclude participation.

• Within the 12 months prior to enrollment, the participant has a history of sexually transmitted infection.

• Chronic Hepatitis B or Hepatitis C infection.

• Laboratory abnormalities in the parameters listed:

• Absolute neutrophil count ≤ 2,000;

• Hemoglobin ≤ 12 gm/dL if female; ≤ 13.5 gm/dL if male;

• Platelet count ≤ 125,000;

• Alanine Aminotransferase (ALT) ≥ 1.25 x ULN; Aspartate Aminotransferase (AST) ≥ 1.25 x ULN;

• Alkaline phosphatase ≥ 1.5 x ULN

• Total bilirubin > 1.0 x ULN;

• Creatinine ≥1.1 x ULN;

• Pregnancy or lactation.

• Any vaccination within 14 days prior to infusion

• Receipt of any experimental HIV vaccine in the past.

• History of severe reaction to a vaccine or drug infusion or history of severe allergic reactions.

• Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.