Safety and Immunotherapeutic Activity of an Anti-PD-1 Antibody (Cemiplimab) in Participants With HIV-1 on Suppressive cART

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT03787095
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • Cemiplimab — BIOLOGICAL
    Administered as an intravenous (IV) infusion
  • Placebo — BIOLOGICAL
    Diluent for REGN2810, administered as an IV infusion

Study Details

The purpose of this study was to evaluate the safety and immunotherapeutic activity of an anti-PD-1 antibody (cemiplimab) in participants with HIV-1 on suppressive combination antiretroviral therapy (cART).

Key Dates

First listed
Dec 26, 2018
Start date
Aug 13, 2019
Status verified
Feb 2022
Primary completion
Aug 18, 2020
Completion
Aug 18, 2020

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Cemiplimab
    Participants received 0.3 mg/kg of cemiplimab, administered at Day 0 and Week 6 for a total of two infusions. Participants continued their current non-study provided ART regimen.
  • Placebo Comparator: Cohort 1: Placebo
    Participants received placebo, administered at Day 0 and Week 6 for a total of two infusions. Participants continued their current non-study provided ART regimen.

Primary Outcome Measure

Count of Participants With a Grade >=3 Adverse Event (AE) or Grade >=1 Immune-related AE (irAE) Related to Study Treatment [ Time Frame: Study Entry through Week 48 or premature discontinuation ]

Locations (3)

FacilityCityStateZIPSite coordinators
Alabama CRSBirminghamAlabama35294-
UCSD Antiviral Research Center CRSSan DiegoCalifornia92103-
Chapel Hill CRSChapel HillNorth Carolina27599-

Find similar trials in Birmingham, AL

By condition
HIV
By specialty
Infectious disease
By research site
Alabama CRS· Birmingham, ALUCSD Antiviral Research Center CRS· San Diego, CAChapel Hill CRS· Chapel Hill, NC

Related Studies