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Monoclonal Antibodies

SAR441236 for HIV

Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intensive sar441236 pk samples taken at hours 0, 2, 4, 6, and 10 and days 1 and 2 after infusions 1 and 4 and non-intensive sampling at pre-dose (weeks 0, week 12, 24, 36) and weeks 2, 4 , 8, 10, 13, 14, 16, 22, 26, 28, 34, 37, 38, 40, and 48.
Awards & highlights

Study Summary

This trial will test a new drug to see if it is safe, works well, and is tolerated by people with HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intensive sar441236 pk samples taken at hours 0, 2, 4, 6, and 10 and days 1 and 2 after infusions 1 and 4 and non-intensive sampling at pre-dose (weeks 0, week 12, 24, 36) and weeks 2, 4 , 8, 10, 13, 14, 16, 22, 26, 28, 34, 37, 38, 40, and 48.
This trial's timeline: 3 weeks for screening, Varies for treatment, and intensive sar441236 pk samples taken at hours 0, 2, 4, 6, and 10 and days 1 and 2 after infusions 1 and 4 and non-intensive sampling at pre-dose (weeks 0, week 12, 24, 36) and weeks 2, 4 , 8, 10, 13, 14, 16, 22, 26, 28, 34, 37, 38, 40, and 48. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Change in Plasma HIV-1 RNA (log10 Copies/mL) From Baseline to Day 7 of SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts)
Mean Dose-normalized AUC 0-12wk of SAR441236
Proportion of Participants Experiencing a Grade 3 or Higher Adverse Event (AE) That is Related to Study Treatment.
Secondary outcome measures
Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort.
Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts.
Clearance or Apparent Clearance of SAR441236 After a Single IV Infusion of SC Injection.
+15 more

Trial Design

10Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm C: 1 mg/kg SAR441236Experimental Treatment1 Intervention
Participants continued non-study-provided ART and received 1 mg/kg of SAR441236, administered as an SC injection(s) on Day 0 (Cohort 11).
Group II: Arm C: 0.3 mg/kg SAR441236Experimental Treatment1 Intervention
Participants continued non-study-provided ART and received 0.3 mg/kg of SAR441236, administered as a subcutaneous (SC) injection(s) on Day 0 (Cohort 10).
Group III: Arm B: 30 mg/kg SAR441236Experimental Treatment1 Intervention
Participants received 30 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 8).
Group IV: Arm B: 1 mg/kg SAR441236Experimental Treatment1 Intervention
Participants received 1 mg/kg of SAR441236, administered as a single IV infusion on Day 0. Antiretroviral treatment was initiated or re-initiated by Day 28 (Cohort 5).
Group V: Arm A: 30 mg/kg SAR441236Experimental Treatment1 Intervention
Participants continued non-study-provided ART and received 30 mg/kg of SAR441236, administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4).
Group VI: Arm A: 3 mg/kg for SAR441236Experimental Treatment1 Intervention
Experimental: Arm A: 3 mg/kg SAR441236 Participants continued on non-study-provided ART, and received 3 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 2).
Group VII: Arm A: 10 mg/kg SAR441236Experimental Treatment1 Intervention
Participants continued non-study-provided ART and received 10 mg/kg of SAR441236, administered as a single IV infusion on Day 0 (Cohort 3).
Group VIII: Arm A: 1 mg/kg SAR441236Experimental Treatment1 Intervention
Participants continued on non-study-provided ART and received 1 mg/kg of SAR441236, administered as a single intravenous (IV) infusion on Day 0 (Cohort 1).
Group IX: Arm C: 0 mg/kg SAR441236Placebo Group1 Intervention
Placebo participants were pooled across those receiving: 0.3 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 10). 1 mg/kg dose volume-equivalent administered as an SC injection(s) (Cohort 11). All continued on non-study provided ART.
Group X: Arm A: 0 mg/kg SAR441236Placebo Group1 Intervention
Placebo participants were pooled across those receiving: 1 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 1). 3 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 2). 10 mg/kg dose volume-equivalent administered as a single IV infusion (Cohort 3) 30 mg/kg dose volume-equivalent administered as an IV infusion on Day 0 and then every 12 weeks for a total of four doses (Cohort 4) All continued on non-study provided ART.

Find a Location

Who is running the clinical trial?

ModeX TherapeuticsIndustry Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,417 Total Patients Enrolled
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,928 Total Patients Enrolled

Media Library

SAR441236 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03705169 — Phase 1
HIV Research Study Groups: Arm C: 0 mg/kg SAR441236, Arm C: 1 mg/kg SAR441236, Arm A: 1 mg/kg SAR441236, Arm A: 3 mg/kg for SAR441236, Arm A: 10 mg/kg SAR441236, Arm A: 30 mg/kg SAR441236, Arm A: 0 mg/kg SAR441236, Arm B: 1 mg/kg SAR441236, Arm B: 30 mg/kg SAR441236, Arm C: 0.3 mg/kg SAR441236
HIV Clinical Trial 2023: SAR441236 Highlights & Side Effects. Trial Name: NCT03705169 — Phase 1
SAR441236 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03705169 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would qualify as an ideal participant for this research?

"This medical trial calls for up to 84 participants between ages 18 and 70 living with HIV-1. To be eligible, applicants must fulfill these criteria."

Answered by AI

Has the Federal Drug Administration authorized Antiretroviral therapy for use?

"Due to the limited evidence surrounding its safety and efficacy, our team has assigned Antiretroviral treatment a score of 1."

Answered by AI

What are the intended outcomes of this medical experiment?

"This trial intends to measure the AUC12wk of SAR441236 over a 24-week period for Cohorts 1-3 and Arms B and C. Secondary endpoints include Trough concentration of SAR441236 after infusion or SC injection measured through laboratory evaluations, Change in plasma HIV-1 RNA (log10 copies/mL) from baseline to Day 14 and 28 of monotherapy also evaluated with lab tests, as well as Maximum reduction of plasma HIV-1 RNA during 28 days of monotherapy for viremic participants with HIV monitored by laboratory evaluations."

Answered by AI

What is the maximum capacity of participants for this clinical experiment?

"This investigation necessitates 84 volunteers that meet the prerequisites for inclusion. Possible study sites include Case Clinical Research Site in Cleveland, OH and Brigham and Women's Hospital Therapeutics Clinical Research Site (BWH TCRS) CRS in Boston, MA."

Answered by AI

Are there multiple sites in the city offering this clinical trial?

"This trial is being carried out at 23 separate sites, with several of them based in Cleveland, Boston, and Providence. For those interested in participating it's urged to select the closest site for their convenience."

Answered by AI

Is it possible to enroll patients in this research endeavor at the present moment?

"Affirmative. Clinicaltrials.gov currently presents that this trial is actively recruiting participants, having been first posted on April 22nd 2019 and most recently updated October 26th 20202. The study requires the enrollment of 84 patients across 23 locations."

Answered by AI

Is this research endeavor enrolling participants who are of legal age?

"As per the eligibility requirements, participants must be aged 18-70 to take part in this trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pharmacokinetics and Safety of SAR441236
2019. "Pharmacokinetics and Safety of SAR441236". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03705169.
~9 spots leftby Apr 2025
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