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Antiretroviral treatment for HIV

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital CRS (MGH CRS), Boston, MAHIVAntiretroviral treatment - Drug
Eligibility
18 - 70
All Sexes
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Study Summary

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Group 5

Study Objectives

4 Primary · 19 Secondary · Reporting Duration: Measured through Week 24 for Cohorts 1-3 and Arms B and C cohorts

Week 36
Change in CD4+ T cell counts (cells/mm^3) from baseline to week 12 following each infusion for Cohort 4
Clearance of SAR441236 after each infusion for Cohort 4
Distribution volume of SAR441236 after each infusion for Cohort 4
Half life of SAR441236 after each infusion for Cohort 4
Maximum concentration of SAR441236 after each infusion for Cohort 4
Time to half life of SAR441236 after each infusion for Cohort 4
Trough concentration of SAR441236 after each infusion for Cohort 4
Week 36
Attributions of anti-SAR441236 antibodies
Occurrence of a Grade 3 or higher adverse event (AE) that is related to study treatment (as judged by the core safety team, blinded to active/placebo treatment in Arms A and C) any time from study treatment administration through the entire follow-up
Measured through Day 28
Change in plasma HIV-1 RNA (copies/mL) from baseline and post infusion for viremic participants with HIV (Arm B cohorts)
Change in plasma HIV-1 RNA (log10 copies/mL) from baseline (defined as the last measurement taken prior to treatment initiation) to Day 14 and Day 28 of monotherapy for Arm B cohorts
Maximum reduction of plasma HIV-1 RNA during 28 days of monotherapy for viremic participants with HIV (Arm B cohorts)
Measured through Day 7
Change in plasma HIV-1 RNA (log10 copies/mL) from baseline (defined as the last measurement taken prior to the treatment initiation) to Day 7 of monotherapy for viremic participants with HIV (Arm B cohorts)
Measured through Week 12
AUC12wk of SAR441236
Change in CD4+ T cell counts (cells/mm^3) from baseline to week 12 following single dose of SAR441236 for all cohorts
Measured through Week 24
Clearance of SAR441236 after infusion or SC injection for Cohorts 1-3 and Arm B and Arm C cohorts
Distribution volume of SAR441236 after infusion or SC injection for Cohorts 1-3 and Arm B and Arm C cohorts
Half life of SAR441236 after infusion or SC injection for Cohorts 1-3 and Arm B and Arm C cohorts
Maximum concentration of SAR441236 after infusion or SC injection for Cohorts 1-3 and Arm B and Arm C cohorts
Time to half life of SAR441236 after infusion or SC injection for Cohorts 1-3 and Arm B and Arm C cohorts
Trough concentration of SAR441236 after infusion or SC injection for Cohorts 1-3 and Arm B and Arm C cohorts
Week 24
Occurrence of a Grade 3 or higher AE that is related to study treatment (as judged by the core safety team, blinded to active/placebo treatment in Arms A and C) any time from study treatment administration through the entire follow-up
Measured through Week 4
Body Weight Changes

Trial Safety

Safety Progress

1 of 3

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1
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Side Effects for

FTC/TDF + 3rd Agent (Double-Blind)
20%Upper respiratory tract infection
13%Diarrhoea
8%Nasopharyngitis
8%Bronchitis
8%Sinusitis
8%Back pain
7%Headache
7%Pain in extremity
7%Fatigue
7%Arthralgia
6%Anxiety
6%Cough
6%Nausea
6%Hypertension
5%Influenza
5%Pyrexia
4%Insomnia
3%Rash
3%Influenza like illness
2%Syphilis
2%Gastroenteritis
1%Onychomycosis
1%Encephalopathy
1%Fungal skin infection
1%Cholecystitis
1%Pneumonia
1%Ankle fracture
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02121795) in the FTC/TDF + 3rd Agent (Double-Blind) ARM group. Side effects include: Upper respiratory tract infection with 20%, Diarrhoea with 13%, Nasopharyngitis with 8%, Bronchitis with 8%, Sinusitis with 8%.

Trial Design

17 Treatment Groups

Arm A, Cohort 1B: Placebo for SAR441236
1 of 17
Arm B, Cohort 6: SAR441236
1 of 17
Arm B, Cohort 7: SAR441236
1 of 17
Arm B, Cohort 8: SAR441236
1 of 17
Arm B, Cohort 9: SAR441236
1 of 17
Arm A, Cohort 4A: SAR441236
1 of 17
Arm C, Cohort 10B: Placebo for SAR441236
1 of 17
Arm C, Cohort 11A: SAR441236
1 of 17
Arm C, Cohort 11B: Placebo for SAR441236
1 of 17
Arm A, Cohort 3A: SAR441236
1 of 17
Arm A, Cohort 3B: Placebo for SAR441236
1 of 17
Arm A, Cohort 4B: Placebo for SAR441236
1 of 17
Arm B, Cohort 5: SAR441236
1 of 17
Arm C, Cohort 10A: SAR441236
1 of 17
Arm A, Cohort 2A: SAR441236
1 of 17
Arm A, Cohort 2B: Placebo for SAR441236
1 of 17
Arm A, Cohort 1A: SAR441236
1 of 17

Experimental Treatment

84 Total Participants · 17 Treatment Groups

Primary Treatment: Antiretroviral treatment · Has Placebo Group · Phase 1

Arm A, Cohort 1B: Placebo for SAR441236Experimental Group · 2 Interventions: Placebo, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm B, Cohort 6: SAR441236Experimental Group · 2 Interventions: SAR441236, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm B, Cohort 7: SAR441236Experimental Group · 2 Interventions: SAR441236, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm B, Cohort 8: SAR441236Experimental Group · 2 Interventions: SAR441236, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm B, Cohort 9: SAR441236Experimental Group · 2 Interventions: SAR441236, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm A, Cohort 4A: SAR441236Experimental Group · 2 Interventions: SAR441236, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm C, Cohort 10B: Placebo for SAR441236Experimental Group · 2 Interventions: Placebo, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm C, Cohort 11A: SAR441236Experimental Group · 2 Interventions: SAR441236, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm C, Cohort 11B: Placebo for SAR441236Experimental Group · 2 Interventions: Placebo, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm A, Cohort 3A: SAR441236Experimental Group · 2 Interventions: SAR441236, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm A, Cohort 3B: Placebo for SAR441236Experimental Group · 2 Interventions: Placebo, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm A, Cohort 4B: Placebo for SAR441236Experimental Group · 2 Interventions: Placebo, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm B, Cohort 5: SAR441236Experimental Group · 2 Interventions: SAR441236, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm C, Cohort 10A: SAR441236Experimental Group · 2 Interventions: SAR441236, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm A, Cohort 2A: SAR441236Experimental Group · 2 Interventions: SAR441236, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm A, Cohort 2B: Placebo for SAR441236Experimental Group · 2 Interventions: Placebo, Antiretroviral treatment · Intervention Types: Biological, Drug
Arm A, Cohort 1A: SAR441236Experimental Group · 2 Interventions: SAR441236, Antiretroviral treatment · Intervention Types: Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2640

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measured through week 24 for cohorts 1-3 and arms b and c cohorts

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,166 Previous Clinical Trials
4,936,996 Total Patients Enrolled
SanofiIndustry Sponsor
2,052 Previous Clinical Trials
2,960,646 Total Patients Enrolled
Athe Tsibris, MD, MSStudy ChairBrigham and Women's Hospital, Harvard Medical School
Daniel R. Kuritzkes, MDStudy ChairBrigham and Women's Hospital Therapeutics CRS, Harvard Medical School
2 Previous Clinical Trials
117 Total Patients Enrolled
Pablo Tebas, MDStudy ChairPenn Therapeutics CRS
18 Previous Clinical Trials
512 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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