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 States, Brazil, Peru40 participantsStarted 2026-12-01
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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial focused primarily on safety — what does that mean for what's actually known right now about whether these two antibodies, VRC07-523LS and PGT121.414.LS, could help control HIV in people like me?
2The trial involves an 'analytic treatment interruption,' meaning I would have to stop my ART for a period — given my current health and viral history, how risky would stopping my antiretroviral therapy actually be for me personally?
3The study is specifically looking for people who started ART during acute or early HIV infection — does my treatment history match that requirement, and is that distinction something that makes me a different kind of candidate than someone who started ART later?
4Since the trial isn't recruiting yet, do you have a sense of when it might open, and is it worth waiting for this study or should we be thinking about other treatment strategies in the meantime?
5One of the main things researchers are measuring is whether people can stay off ART with their viral load below 200 copies/mL — if that doesn't happen for me during the trial, what would the plan be to get me back on treatment safely??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)