Last updated on July 2019

Pharmacokinetics of SAR441236


Brief description of study

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of SAR441236, a tri-specific broadly neutralizing antibody against the human immunodeficiency virus (HIV).

Detailed Study Description

This study will evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of SAR441236, a tri-specific broadly neutralizing antibody against HIV.

The study includes two arms. In Arm A, three cohorts of antiretroviral-treated, virologically suppressed participants will be randomized to receive a single intravenous (IV) dose of SAR441236 or placebo on Day 0. After Cohort 1, each subsequent cohort will open for enrollment only after an evaluation of safety outcomes for all participants in the previous cohort indicates that it is safe to increase the dose of SAR441236. All participants in Cohorts 1-3 will be followed for 24 weeks.

In Arm A, Cohort 4, participants will be randomized to receive an IV infusion of SAR441236 or placebo once every 12 weeks beginning at entry, for a total of 4 infusions. Participants in this cohort will be followed for 72 weeks.

Participants in Arm A will continue taking non-study-provided antiretroviral treatment throughout the study.

In Arm B, four cohorts of ART nave, viremic participants will each receive a single IV dose of SAR441236 on Day 0. After Cohort 5, each subsequent cohort will be opened for enrollment after an evaluation of safety outcomes for all participants in the previous cohort indicates that it is safe to increase the dose of SAR441236.

Based on an evaluation of virologic study data, an additional Arm B cohort of antiretroviral nave, viremic participants, Cohort 9, may open at a lower dose. Participants in Cohort 9 will receive a single IV dose of SAR441236. All Arm B participants will be followed for 24 weeks.

Participants in Arm B will initiate non-study-provided combination antiretroviral therapy (selected by their primary HIV clinician) on Day 28.

Clinical Study Identifier: NCT03705169

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Northwestern University CRS

Chicago, IL United States
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Weill Cornell Chelsea CRS

New York, NY United States
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Columbia P&S CRS

New York, NY United States
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Weill Cornell Uptown CRS

New York, NY United States
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Chapel Hill CRS

Chapel Hill, NC United States
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Case Clinical Research Site

Cleveland, OH United States
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Ucsf Hiv/Aids Crs

San Francisco, CA United States
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University of Pittsburgh CRS

Pittsburgh, PA United States
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Alabama CRS

Birmingham, AL United States
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Penn Therapeutics, CRS

Philadelphia, PA United States
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UCLA CARE Center CRS

Los Angeles, CA United States
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Rush University CRS

Chicago, IL United States
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Ohio State University CRS

Columbus, OH United States
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Recruitment Status: Open


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