A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-523LS and PGT121.414.LS) During Analytic Treatment Interruption in Participants Living With HIV Who Initiated ART During Acute/Early HIV-1 Infection

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06987318
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • HIV-1-infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • VRC07-523LS — BIOLOGICAL
    Administered by Intravenous (IV) infusion at Week 0 and 12 weeks later
  • PGT121.414.LS — BIOLOGICAL
    Administered by IV infusion at Week 0

Study Details

The purpose of this study is to evaluate the safety, tolerability, and efficacy of combination broadly neutralizing antibodies (bNAbs), to induce HIV-1 control during analytic treatment interruption (ATI).

Key Dates

Start date
Jun 12, 2026
Status verified
Nov 2025
Primary completion
Aug 29, 2027
Completion
May 7, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
  • Experimental: Arm B

Primary Outcome Measure

Number of participants experiencing a Grade ≥3 Adverse Event (AE) or Serious Adverse Events (SAE) that are related to VRC07-523LS or PGT121.414.LS [ Time Frame: Baseline through 36 weeks after the last dose of study treatment received ]

Locations (10)

FacilityCityStateZIPSite coordinators
Alabama CRSBirminghamAlabama35222
Heather Logan
[email protected]
205-934-6774
UCSD Antiviral Research Center CRSSan DiegoCalifornia92103
Steven Hendrickx
[email protected]
619-543-6968
University of Colorado Hospital CRSAuroraColorado80045
Nicola Haakonsen
303-724-5931
The Ponce de Leon Center CRSAtlantaGeorgia30308-2012
Ericka R. Patrick
[email protected]
404-616-6313
Northwestern University CRSChicagoIllinois60611
Baiba Berzins
[email protected]
312-695-5012
Massachusetts General Hospital CRS (MGH CRS)BostonMassachusetts02114
Amy Sbrolla
[email protected]
617-726-5598
Chapel Hill CRSChapel HillNorth Carolina27599-7215
Erin Hoffman
[email protected]
919-843-0720
Ohio State University CRSColumbusOhio43210
Lindsay Summers
[email protected]
614-293-8529
Penn Therapeutics CRSPhiladelphiaPennsylvania19104
Jason Kirschner
[email protected]
215-615-2316
Houston Advancing Research Team CRSHoustonTexas77030
Maria Laura Martinez
[email protected]
713-500-6718

Find similar trials in Birmingham, AL

By research site
Alabama CRS· Birmingham, ALUCSD Antiviral Research Center CRS· San Diego, CAUniversity of Colorado Hospital CRS· Aurora, COThe Ponce de Leon Center CRS· Atlanta, GANorthwestern University CRS· Chicago, ILMassachusetts General Hospital CRS (MGH CRS)· Boston, MA

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