A Study to Evaluate the Safety and Antiviral Activity of Two Human Monoclonal Antibodies (VRC07-5… (NCT06987318) | Clinical Trial Compass
Not Yet RecruitingPhase 1
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
United States40 participantsStarted 2026-06-12
Plain-language summary
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).
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Ability and willingness of participant to provide informed consent.
* Initiation of combination ART within 90 days of acute HIV diagnosis as defined by any of the criteria listed below:
* A negative HIV Ab or HIV Ag/Ab Combination Assay and a detectable HIV-1 RNA (qualitative or quantitative) or a subsequently positive Western blot (WB) or equivalent HIV-1 confirmatory assay (e.g. Geenius assay) if no positive HIV-1 RNA test was available.
* A positive HIV Ab or HIV Ag/Ab Combination Assay or p24 antigen test and a negative or indeterminate HIV confirmatory/differentiating test with a detectable HIV-1 RNA (qualitative or quantitative).
* A positive HIV Ab or HIV-1 RNA or p24 antigen and positive WB or Geenius HIV-1/HIV-2 Supplemental Assay that is negative for p31 band.
* Two different rapid HIV tests with discordant results followed by subsequently positive HIV serum antibody and/or HIV-1 RNA tests.
* A positive HIV antibody test according to standard criteria obtained within 60 days after an initial negative or indeterminate HIV antibody, antigen, or nucleic acid amplification.
* For women who are able to become pregnant, negative serum or urine pregnancy test within 48 hours prior to Step 1 entry.
* All study candidates must agree not to participate in an assisted conception process (e.g., sperm donation, intrauterine insemination, in vitro fertilization) from the screening visit until 12 weeks after the final study visit.
* Women who can …
What they're measuring
1
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
Timeframe: Baseline through 36 weeks after the last dose of study treatment received
2
Proportion of study participants experiencing viral suppression, defined as HIV-1 RNA <200 copies/mL and remaining off ART
Timeframe: At 62 weeks after Step 1 entry
Trial details
NCT IDNCT06987318
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)