A Study of the Safety, Pharmacokinetics and Antiretroviral Activity of 10-1074

Completed · Phase 1

Conditions studied: Healthy, HIV

In brief

This is a phase 1 clinical trial to evaluate the safety, pharmacokinetics and the antiretroviral effects of the highly neutralizing anti-HIV-1 monoclonal antibody 10-1074 in HIV-infected and HIV-uninfected individuals.

Key facts

Study ID

NCT02511990

Run by

Rockefeller University

People needed

33

Starts

2015-07-01

Expected to finish

2017-12-01

Last updated by the study team

2018-02-05

Who can join

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

You may qualify if…

• Group 1 (HIV-infected)
• Males and females, age 18 to 65
• HIV-1 infection confirmed by two independent assays.
• Group (1A-1C): HIV-infected individuals off ART for at least 8 weeks with HIV-1 plasma RNA levels < 100,000 copies/ml by standard assays, or on ART with HIV-1 plasma RNA levels < 500 copies/ml. HIV-1 RNA levels should be measured on 2 occasions, at least 1 week apart and one measurement must be performed within 49 days prior to enrollment.
• Group (1D): HIV-infected individuals off ART for at least 8 weeks with HIV-1 plasma RNA levels < 100,000 copies/ml by standard assays, measured on 2 occasions, at least 1 week apart. At least one measurement must be performed within 49 days prior to enrollment.
• Current CD4 count > 300 cells/μl.
• If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use two effective methods of contraception from 10 days prior to the 10-1074 infusion until the end of the study.
• Group 2 (HIV-uninfected):
• 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 throughout the study period, as described for the HIV-infected groups above.

You may not qualify if…

• Group 1 (HIV-infected):
• Have a history of AIDS-defining illness within 1 year prior to enrollment.
• 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.
• Chronic Hepatitis B or Hepatitis C infection.
• Laboratory abnormalities in the parameters listed below:
• Absolute neutrophil count ≤ 1,000; Hemoglobin ≤10 gm/dL; Platelet count ≤100,000; ALT ≥ 2.0 x ULN; AST ≥ 2.0 x ULN; Total bilirubin ≥ 1.25 x ULN; Creatinine ≥ 1.1 x ULN; Coagulation parameters (PT, PTT or INR) ≥ 1.25 x ULN.
• Pregnancy or lactation.
• Any vaccination within 14 days prior to 10-1074 administration.
• 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.
• Group 2 (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 (such as autoimmune diseases) 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 infection.
• Chronic Hepatitis B or Hepatitis C infection.
• Laboratory abnormalities in the parameters listed:
• Absolute neutrophil count ≤ 1,500; Hemoglobin ≤ 12 gm/dL if female; ≤ 13.5 gm/dL if male; Platelet count ≤ 140,000; Alanine transaminase (ALT) ≥ 1.25 x upper limit of normal (ULN); aspartate transaminase (AST) ≥ 1.25 x ULN; Total bilirubin ≥ 1.25 x ULN; Creatinine ≥ 1.1 x ULN; Coagulation parameters (prothrombin time - PT, partial thromboplastin time - PTT or INR) ≥ 1.25 x ULN.
• Pregnancy or lactation.
• Any vaccination within 14 days prior to 10-1074 administration.
• 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.

Where it is running

• The Rockefeller University — New York, New York, United States
• University of Cologne — Cologne, Germany

Full record on ClinicalTrials.gov

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