NCT03705169 is a Phase 1 clinical trial of SAR441236 in HIV-1-infection, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Who is sponsoring NCT03705169?

NCT03705169 is sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

What drugs are being tested in NCT03705169?

Interventions in NCT03705169: SAR441236, Placebo.

What condition does NCT03705169 study?

NCT03705169 studies HIV-1-infection.

Is NCT03705169 still recruiting?

NCT03705169 is currently terminated. Last updated 12 January 2024.

Are results published for NCT03705169?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-01-12 · How we verify

NCT03705169

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pharmacokinetics and Safety of SAR441236

Terminated Phase 1 Results posted Last updated 12 January 2024

What this trial tests

Phase 1 trial testing SAR441236 in HIV-1-infection in 52 participants. Terminated before completion.

Timeline

20 May 2019

Primary endpoint
4 April 2022

4 April 2022

Quick facts

Lead sponsor	National Institute of Allergy and Infectious Diseases (NIAID)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	52
Start date	20 May 2019
Primary completion	4 April 2022
Estimated completion	4 April 2022
Sites	23 locations across United States

Drugs / interventions tested

SAR441236 — full drug profile →
Placebo

Conditions studied

HIV-1-infection — all drugs for HIV-1-infection →

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Who can join

Adults 18 to 70, any sex, with HIV-1-infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Participants Experiencing a Grade 3 or Higher Adverse Event (AE) That is Related to Study Treatment. Primary · Measured from Day 0 through entire study follow-up, up to 24 weeks post study treatment administration for single dose cohorts (all arms) and up to 36 weeks after the fourth study treatment administration for the multi-dose cohort (Arm A only).

The proportion of participants reporting a grade 3 (severe), grade 4 (potentially life-threatening), or grade 5 (death) adverse event, that was judged by the core safety team (blinded to active/placebo treatment in Arms A and C) to be at least possibly related to study treatment. Based on the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017

Group	Value	95% CI
Arm A: 1 mg/kg SAR441236	0	0 – 0.60
Arm A: 3 mg/kg for SAR441236	0	0 – 0.60
Arm A: 10 mg/kg SAR441236	0	0 – 0.60
Arm A: 30 mg/kg SAR441236	0	0 – 0.31
Arm A: 0 mg/kg SAR441236	0	0 – 0.31
Arm B: 1 mg/kg SAR441236	0	0 – 0.52
Arm B: 30 mg/kg SAR441236	0	0 – 0.84
Arm C: 0.3 mg/kg SAR441236	0	0 – 0.6
Arm C: 1 mg/kg SAR441236	0	0 – 0.6
Arm C: 0 mg/kg SAR441236	0	0 – 0.6

Mean Dose-normalized AUC 0-12wk of SAR441236 Primary · SAR441236 PK samples at pre-dose, Hours 0, 2 (Arm A, B only) , 4 (Arm A, B only), 6 (Arm A, B only), and 10, Days 1, 2, 3, 4 (Arm B only), 7, 10 (Arm B only), and Weeks 2, 4, 8 (single dose only), 10 (multi dose only), and 12.

Dose-normalized Area Under the Concentration time curve (AUC) for each participant was calculated from all available SAR441236 concentrations measured prior to and after first treatment and prior to any subsequent treatment instances (Arm A: 30 mg/kg only). Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine AUC 0-12WK.

Group	Value	95% CI
Arm A: 1 mg/kg SAR441236	593	± 282
Arm A: 3 mg/kg for SAR441236	631	± 120
Arm A: 10 mg/kg SAR441236	610	± 54.5
Arm A: 30 mg/kg SAR441236	743	± 296
Arm B: 1 mg/kg SAR441236	552
Arm B: 30 mg/kg SAR441236	159
Arm C: 0.3 mg/kg SAR441236	254	± 145
Arm C: 1 mg/kg SAR441236	236	± 126

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) Primary · Measured at Day 0 and Day 7

Baseline was defined as the last measurement taken prior to treatment initiation. Change was calculated as the log10-transformed value on Day 7 minus the log10-transformed value at baseline.

Group	Value	95% CI
Arm B: 1 mg/kg SAR441236	-0.10	± 0.42
Arm B: 30 mg/kg SAR441236	-0.38	± 0.24

Mean Change in Plasma HIV-1 RNA (log10 Copies/mL) From Baseline to Post-infusion Time Points During SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts) Secondary · Measured at Day 0 and at Day 1, 2, 3, and 4, and Week 1, 2, and 3

Baseline was defined as the last measurement taken prior to treatment initiation. Change was calculated as the log10-transformed value of plasma HIV-1 RNA at the post-infusion time point minus the log10-transformed value at baseline.

Change from baseline to Day 1

Group	Value	95% CI
Arm B: 1 mg/kg SAR441236	0.04	± 0.07
Arm B: 30 mg/kg SAR441236	0.10	± 0.12

Change from baseline to Day 2

Group	Value	95% CI
Arm B: 1 mg/kg SAR441236	0.04	± 0.14
Arm B: 30 mg/kg SAR441236	-0.06	± 0.07

Change from baseline to Day 3

Group	Value	95% CI
Arm B: 1 mg/kg SAR441236	-0.04	± 0.20
Arm B: 30 mg/kg SAR441236	-0.39	± 0.04

Change from baseline to Day 4

Group	Value	95% CI
Arm B: 1 mg/kg SAR441236	0.01	± 0.40
Arm B: 30 mg/kg SAR441236	-0.68	± 0.03

Change from baseline to Week 1

Group	Value	95% CI
Arm B: 1 mg/kg SAR441236	-0.10	± 0.42
Arm B: 30 mg/kg SAR441236	-0.38	± 0.24

Change from baseline to Week 2

Group	Value	95% CI
Arm B: 1 mg/kg SAR441236	-0.08	± 0.08
Arm B: 30 mg/kg SAR441236	0.09	± 0.38

Change from baseline to Week 3

Group	Value	95% CI
Arm B: 1 mg/kg SAR441236	0.03	± 0.37
Arm B: 30 mg/kg SAR441236	0.07	± 0.48

Mean Change in Plasma HIV-1 RNA (log10 Copies/mL) From Baseline to Day 14 of SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts) Secondary · Measured at Day 0 and Day 14

Baseline was defined as the last measurement taken prior to treatment initiation. Change was calculated as the value of plasma HIV-1 RNA on Day 14 minus the value at baseline.

Group	Value	95% CI
Arm B: 1 mg/kg SAR441236	-0.08	± 0.08
Arm B: 30 mg/kg SAR441236	0.09	± 0.38

Mean Maximum Reduction of Plasma HIV-1 RNA During up to 28 Days of SAR441236 Monotherapy for Viremic Participants With HIV (Arm B Cohorts) Secondary · Measured at Day 0 and at up to Day 28 (while on SAR441236 monotherapy)

The maximum reduction in plasma HIV-1 RNA was calculated as the largest decline from baseline, defined as the last measurement taken prior to treatment initiation, to any post-infusion timepoint while the participant was on SAR441236 monotherapy (i.e., prior to initiating or reinitiating ART).

Group	Value	95% CI
Arm B: 1 mg/kg SAR441236	-0.30	± 0.23
Arm B: 30 mg/kg SAR441236	-0.68	± 0.03

Attributions of Anti-SAR441236 Antibodies Among Participants in Single-dose Cohorts. Secondary · Measured at Day 0 and at Week 2, 4, 12, and 24

Number of participants who were anti-drug antibody (ADA) negative, ADA positive (treatment induced), and missing were calculated at each sampled timepoint.

ADA Status at Day 0

Group	Value	95% CI
Arm A: 1 mg/kg SAR441236	0
Arm A: 3 mg/kg for SAR441236	0
Arm A: 10 mg/kg SAR441236	0
Arm B: 1 mg/kg SAR441236	0
Arm B: 30 mg/kg SAR441236	0
Arm C: 0.3 mg/kg SAR441236	0
Arm C: 1 mg/kg SAR441236	0
Arm A: 1 mg/kg SAR441236	4
Arm A: 3 mg/kg for SAR441236	4
Arm A: 10 mg/kg SAR441236	4
Arm B: 1 mg/kg SAR441236	5
Arm B: 30 mg/kg SAR441236	2
Arm C: 0.3 mg/kg SAR441236	4
Arm C: 1 mg/kg SAR441236	4
Arm A: 1 mg/kg SAR441236	0
Arm A: 3 mg/kg for SAR441236	0
Arm A: 10 mg/kg SAR441236	0
Arm B: 1 mg/kg SAR441236	0
Arm B: 30 mg/kg SAR441236	0
Arm C: 0.3 mg/kg SAR441236	0
Arm C: 1 mg/kg SAR441236	0

ADA Status at Week 2

Group	Value	95% CI
Arm A: 1 mg/kg SAR441236	0
Arm A: 3 mg/kg for SAR441236	0
Arm A: 10 mg/kg SAR441236	1
Arm B: 1 mg/kg SAR441236	1
Arm B: 30 mg/kg SAR441236	1
Arm C: 0.3 mg/kg SAR441236	0
Arm C: 1 mg/kg SAR441236	1
Arm A: 1 mg/kg SAR441236	4
Arm A: 3 mg/kg for SAR441236	4
Arm A: 10 mg/kg SAR441236	3
Arm B: 1 mg/kg SAR441236	3
Arm B: 30 mg/kg SAR441236	1
Arm C: 0.3 mg/kg SAR441236	4
Arm C: 1 mg/kg SAR441236	3
Arm A: 1 mg/kg SAR441236	0
Arm A: 3 mg/kg for SAR441236	0
Arm A: 10 mg/kg SAR441236	0
Arm B: 1 mg/kg SAR441236	1
Arm B: 30 mg/kg SAR441236	0
Arm C: 0.3 mg/kg SAR441236	0
Arm C: 1 mg/kg SAR441236	0

ADA Status at Week 4

Group	Value	95% CI
Arm A: 1 mg/kg SAR441236	0
Arm A: 3 mg/kg for SAR441236	0
Arm A: 10 mg/kg SAR441236	1
Arm B: 1 mg/kg SAR441236	4
Arm B: 30 mg/kg SAR441236	0
Arm C: 0.3 mg/kg SAR441236	0
Arm C: 1 mg/kg SAR441236	0
Arm A: 1 mg/kg SAR441236	3
Arm A: 3 mg/kg for SAR441236	4
Arm A: 10 mg/kg SAR441236	3
Arm B: 1 mg/kg SAR441236	1
Arm B: 30 mg/kg SAR441236	2
Arm C: 0.3 mg/kg SAR441236	4
Arm C: 1 mg/kg SAR441236	4
Arm A: 1 mg/kg SAR441236	1
Arm A: 3 mg/kg for SAR441236	0
Arm A: 10 mg/kg SAR441236	0
Arm B: 1 mg/kg SAR441236	0
Arm B: 30 mg/kg SAR441236	0
Arm C: 0.3 mg/kg SAR441236	0
Arm C: 1 mg/kg SAR441236	0

ADA Status at Week 12

Group	Value	95% CI
Arm A: 1 mg/kg SAR441236	0
Arm A: 3 mg/kg for SAR441236	1
Arm A: 10 mg/kg SAR441236	1
Arm B: 1 mg/kg SAR441236	2
Arm B: 30 mg/kg SAR441236	0
Arm C: 0.3 mg/kg SAR441236	0
Arm C: 1 mg/kg SAR441236	1
Arm A: 1 mg/kg SAR441236	4
Arm A: 3 mg/kg for SAR441236	3
Arm A: 10 mg/kg SAR441236	3
Arm B: 1 mg/kg SAR441236	0
Arm B: 30 mg/kg SAR441236	1
Arm C: 0.3 mg/kg SAR441236	4
Arm C: 1 mg/kg SAR441236	3
Arm A: 1 mg/kg SAR441236	0
Arm A: 3 mg/kg for SAR441236	0
Arm A: 10 mg/kg SAR441236	0
Arm B: 1 mg/kg SAR441236	3
Arm B: 30 mg/kg SAR441236	1
Arm C: 0.3 mg/kg SAR441236	0
Arm C: 1 mg/kg SAR441236	0

ADA Status at Week 24

Group	Value	95% CI
Arm A: 1 mg/kg SAR441236	0
Arm A: 3 mg/kg for SAR441236	1
Arm A: 10 mg/kg SAR441236	0
Arm B: 1 mg/kg SAR441236	3
Arm B: 30 mg/kg SAR441236	0
Arm C: 0.3 mg/kg SAR441236	0
Arm C: 1 mg/kg SAR441236	2
Arm A: 1 mg/kg SAR441236	4
Arm A: 3 mg/kg for SAR441236	3
Arm A: 10 mg/kg SAR441236	4
Arm B: 1 mg/kg SAR441236	0
Arm B: 30 mg/kg SAR441236	0
Arm C: 0.3 mg/kg SAR441236	4
Arm C: 1 mg/kg SAR441236	2
Arm A: 1 mg/kg SAR441236	0
Arm A: 3 mg/kg for SAR441236	0
Arm A: 10 mg/kg SAR441236	0
Arm B: 1 mg/kg SAR441236	2
Arm B: 30 mg/kg SAR441236	2
Arm C: 0.3 mg/kg SAR441236	0
Arm C: 1 mg/kg SAR441236	0

Attributions of Anti-SAR441236 Antibodies Among Participants in Multi-dose Cohort. Secondary · Measured at Day 0, at Weeks 2 and 4 after Infusion 1, at Infusion 2, at Infusion 3, at Infusion 4, and at Weeks 12 and 36 post-Infusion 4

Number of participants who were anti-drug antibody (ADA) negative, ADA positive (treatment induced), and missing were calculated at each sampled timepoint.

ADA Status at Inf 1: Day 0

Group	Value	95% CI
Arm A: 30 mg/kg SAR441236	0
Arm A: 30 mg/kg SAR441236	9
Arm A: 30 mg/kg SAR441236	0

ADA Status at Inf 1: Week 2

Group	Value	95% CI
Arm A: 30 mg/kg SAR441236	0
Arm A: 30 mg/kg SAR441236	8
Arm A: 30 mg/kg SAR441236	1

ADA Status at Inf 1: Week 4

Group	Value	95% CI
Arm A: 30 mg/kg SAR441236	0
Arm A: 30 mg/kg SAR441236	7
Arm A: 30 mg/kg SAR441236	2

ADA Status at Inf 2: Day 0

Group	Value	95% CI
Arm A: 30 mg/kg SAR441236	1
Arm A: 30 mg/kg SAR441236	5
Arm A: 30 mg/kg SAR441236	3

ADA Status at Inf 3: Day 0

Group	Value	95% CI
Arm A: 30 mg/kg SAR441236	0
Arm A: 30 mg/kg SAR441236	6
Arm A: 30 mg/kg SAR441236	3

ADA Status at Inf 4: Day 0

Group	Value	95% CI
Arm A: 30 mg/kg SAR441236	0
Arm A: 30 mg/kg SAR441236	6
Arm A: 30 mg/kg SAR441236	3

ADA Status at Inf 4: Week 12

Group	Value	95% CI
Arm A: 30 mg/kg SAR441236	0
Arm A: 30 mg/kg SAR441236	6
Arm A: 30 mg/kg SAR441236	3

ADA Status at Inf 4: Week 36

Group	Value	95% CI
Arm A: 30 mg/kg SAR441236	1
Arm A: 30 mg/kg SAR441236	4
Arm A: 30 mg/kg SAR441236	4

Mean Change From Baseline in CD4+ T Cell Counts Following the First Treatment of SAR441236 or Placebo for All Cohorts Secondary · Measured at Day 0 and Week 12

Baseline was defined as the last measurement obtained prior to treatment initiation. Change was calculated as the value of CD4+ T cell counts (cells/mm\^3) at Week 12 (prior to subsequent study treatment, if any) minus the value at baseline.

Group	Value	95% CI
Arm A: 1 mg/kg SAR441236	-6	± 87
Arm A: 3 mg/kg for SAR441236	-96	± 222
Arm A: 10 mg/kg SAR441236	96	± 249
Arm A: 30 mg/kg SAR441236	-36	± 246
Arm A: 0 mg/kg SAR441236	-43	± 117
Arm B: 1 mg/kg SAR441236	10	± 273
Arm B: 30 mg/kg SAR441236	138	± NA
Arm C: 0.3 mg/kg SAR441236	61	± 176
Arm C: 1 mg/kg SAR441236	-136	± 216
Arm C: 0 mg/kg SAR441236	-53	± 289

Mean Change From Baseline in CD4+ T Cell Counts Following Each Infusion for Cohort 4 Secondary · Measured at Day 0 and at Week 12 after each infusion

Baseline was defined as the last measurement obtained prior to treatment initiation. Change was calculated as the value of CD4 + T cell counts (cells/mm\^3) at Week 12 after each infusion minus the value at baseline.

Change in from baseline to Week 12 after 2nd treatment

Group	Value	95% CI
Arm A: 30 mg/kg SAR441236	73	± 357
Arm A: 0 mg/kg SAR441236	28	± 190

Change in from baseline to Week 12 after 3rd treatment

Group	Value	95% CI
Arm A: 30 mg/kg SAR441236	78	± 232
Arm A: 0 mg/kg SAR441236	17	± 252

Change in from baseline to Week 12 after 4th treatment

Group	Value	95% CI
Arm A: 30 mg/kg SAR441236	-83	± 253
Arm A: 0 mg/kg SAR441236	77	± 111

Mean Maximum Concentration (Cmax) of SAR441236 After a Single IV Infusion or SC Injection. Secondary · SAR441236 PK samples at pre-dose, Hours 0, 2 (Arm A, B only) , 4 (Arm A, B only), 6 (Arm A, B only), and 10, Days 1, 2, 3, 4 (Arm B only), 7, 10 (Arm B only), and Weeks 2, 4, 8 (single dose only), 10 (multi dose only), 12, and 24 (single dose only).

Cmax for each participant was calculated as the maximum observed concentration from all available SAR441236 concentrations measured prior to and after first treatment and prior to any subsequent treatment instances (Arm A: 30 mg/kg only). Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine Cmax.

Group	Value	95% CI
Arm A: 1 mg/kg SAR441236	25.2	± 11
Arm A: 3 mg/kg for SAR441236	72.7	± 27.7
Arm A: 10 mg/kg SAR441236	295	± 265
Arm A: 30 mg/kg SAR441236	771	± 250
Arm B: 1 mg/kg SAR441236	24.9	± 3.5
Arm B: 30 mg/kg SAR441236	483	± 249
Arm C: 0.3 mg/kg SAR441236	1.69	± 0.74
Arm C: 1 mg/kg SAR441236	4.77	± 2.32

Half-life (T1/2) of SAR441236 After a Single IV Infusion or SC Injection. Secondary · SAR441236 PK samples at pre-dose, Hours 0, 2 (Arm A, B only) , 4 (Arm A, B only), 6 (Arm A, B only), and 10, Days 1, 2, 3, 4 (Arm B only), 7, 10 (Arm B only), and Weeks 2, 4, 8 (single dose only), 10 (multi dose only), 12, and 24 (single dose only).

Half-life for each participant was calculated using regression analysis on all available SAR441236 concentrations measured prior to and after first treatment and prior to any subsequent treatment instances (Arm A: 30 mg/kg only). Standard noncompartmental techniques, using Phoenix WinNonlin, were used to determine half-life.

Group	Value	95% CI
Arm A: 1 mg/kg SAR441236	34.8	± 4.73
Arm A: 3 mg/kg for SAR441236	38.1	± 4.94
Arm A: 10 mg/kg SAR441236	30.9	± 4.90
Arm A: 30 mg/kg SAR441236	37.0	± 6.46
Arm B: 1 mg/kg SAR441236	27.2	± 2.37
Arm B: 30 mg/kg SAR441236	23.2	± 3.97
Arm C: 0.3 mg/kg SAR441236	58.5	± 1.41
Arm C: 1 mg/kg SAR441236	47.7	± 6.13

Adverse events — posted to ClinicalTrials.gov

Time frame: From study entry to study completion (36 weeks after the final infusion for Cohort 4 and 24 weeks after the first infusion/injection for other cohorts) or premature study discontinuation.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A: 1mg/kg SAR441236

Serious: 1/4 (25%)

Deaths: 0/4

Arm A: 3 mg/kg SAR441236

Serious: 0/4 (0%)

Deaths: 0/4

Arm A: 10 mg/kg SAR441236

Serious: 0/4 (0%)

Deaths: 0/4

Arm A: 30 mg/kg SAR441236

Serious: 2/11 (18%)

Deaths: 0/11

Arm A: 0 mg/kg SAR441236

Serious: 0/10 (0%)

Deaths: 0/10

Arm B: 1 mg/kg SAR441236

Serious: 1/5 (20%)

Deaths: 0/5

Arm B: 30 mg/kg SAR441236

Serious: 0/2 (0%)

Deaths: 0/2

Arm C: 0.3 mg/kg SAR441236

Serious: 0/4 (0%)

Deaths: 0/4

Arm C: 1 mg/kg SAR441236

Serious: 0/4 (0%)

Deaths: 0/4

Arm C: 0 mg/kg SAR441236

Serious: 0/4 (0%)

Deaths: 0/4

Serious adverse events (4 terms)

Reaction	System	Arm A: 1mg/kg SAR441236	Arm A: 3 mg/kg 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	Arm C: 1 mg/kg SAR441236	Arm C: 0 mg/kg SAR441236
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Soft tissue infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—	—	—	—	—
Suicidal ideation	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—

Other adverse events (61 terms — click to expand)

Reaction	System	Arm A: 1mg/kg SAR441236	Arm A: 3 mg/kg 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	Arm C: 1 mg/kg SAR441236	Arm C: 0 mg/kg SAR441236
Creatinine renal clearance decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—	—	—	—
Blood glucose increased	Investigations	—	—	—	—	—	—	—	—	—	—
Blood uric acid increased	Investigations	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—
External ear pain	Ear and labyrinth disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—	—	—
Injection site erythema	General disorders	—	—	—	—	—	—	—	—	—	—
Injection site swelling	General disorders	—	—	—	—	—	—	—	—	—	—
Localised oedema	General disorders	—	—	—	—	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—	—	—	—	—	—
Pain	General disorders	—	—	—	—	—	—	—	—	—	—
Bronchitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Cellulitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Fungal foot infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Fungal skin infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Pharyngitis streptococcal	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Tooth infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—	—	—
Joint dislocation	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Skin laceration	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—
Blood albumin decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Blood bicarbonate decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Blood sodium increased	Investigations	—	—	—	—	—	—	—	—	—	—
Neutrophil count decreased	Investigations	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Pneumonia, Soft tissue infection, Malignant melanoma, Suicidal ideation.

Data from ClinicalTrials.gov NCT03705169 adverse events section.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Two Randomized Trials of Neutralizing Antibodies to Prevent HIV-1 Acquisition.
Corey L, Gilbert PB, Juraska M, Montefiori DC, et al · · 2021 · cited 457× · PMID 33730454 · DOI 10.1056/nejmoa2031738
Antibodies to combat viral infections: development strategies and progress.
Pantaleo G, Correia B, Fenwick C, Joo VS, et al · · 2022 · cited 210× · PMID 35725925 · DOI 10.1038/s41573-022-00495-3
Avidity in antibody effector functions and biotherapeutic drug design.
Oostindie SC, Lazar GA, Schuurman J, Parren PWHI. · · 2022 · cited 170× · PMID 35790857 · DOI 10.1038/s41573-022-00501-8
Safety and antiviral activity of triple combination broadly neutralizing monoclonal antibody therapy against HIV-1: a phase 1 clinical trial.
Julg B, Stephenson KE, Wagh K, Tan SC, et al · · 2022 · cited 126× · PMID 35551291 · DOI 10.1038/s41591-022-01815-1
Broadly neutralizing antibodies for the treatment and prevention of HIV infection.
Caskey M. · · 2020 · cited 81× · PMID 31764199 · DOI 10.1097/coh.0000000000000600
Biology drives the discovery of bispecific antibodies as innovative therapeutics.
Nie S, Wang Z, Moscoso-Castro M, D'Souza P, et al · · 2020 · cited 79× · PMID 33928225 · DOI 10.1093/abt/tbaa003
Clinical Trials of Broadly Neutralizing Monoclonal Antibodies for Human Immunodeficiency Virus Prevention: A Review.
Mahomed S, Garrett N, Baxter C, Abdool Karim Q, et al · · 2021 · cited 77× · PMID 32604408 · DOI 10.1093/infdis/jiaa377
Broadly Neutralizing Antibodies for HIV-1 Prevention.
Walsh SR, Seaman MS. · · 2021 · cited 73× · PMID 34354713 · DOI 10.3389/fimmu.2021.712122

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03705169 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID)
Last refreshed: 12 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03705169.

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NCT03705169

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (4 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for HIV-1-infection

Other National Institute of Allergy and Infectious Diseases (NIAID) trials

Verify against primary sources