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HIV-1-infectionPhase 1NCT06987318

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

A Phase 1 study testing VRC07-523LS and PGT121.414.LS in people with HIV-1-infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in 3 countries.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
HIV-1-infection
What is being tested?
VRC07-523LS and PGT121.414.LS
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
13 sitesin 3 countries
Study dates
1 Dec 2026to 7 May 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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 become pregnant and are engaging in sexual activity that could lead to pregnancy must agree to use one highly effective method of contraception from Step 1 entry until 12 weeks after the final study visit.
  • Willingness to use barrier protection (male or female) during sexual activity during ATI and through confirmed viral resuppression.
  • Weight ≥50 kg and ≤150 kg at screening.
  • On stable suppressive ART for at least 12 months prior to Step 1 entry. No known ART interruption for longer than 14 days within 12 months prior to Step 1 entry. No more than two known ART interruptions of a duration between 14 and 60 consecutive days since initiation of ART.
  • ART regimens must contain a protease inhibitor (PI) or integrase strand transfer inhibitor (INSTI) as one of the active drugs in the ART regimen at the time of Step 1 entry.
  • CD4+ cell count of >450 cells/mL obtained within 60 days prior to Step 1 entry.
  • Within 60 days prior to Step 1 entry, plasma HIV-1 RNA < 50 copies/mL of plasma.
  • Plasma HIV-1 RNA <50 copies/mL (or below the assay limit of quantification if the local assay limit of quantification is >50 copies/mL) since initial viral suppression on ART and for at least 1 year prior to Step 1 entry.
  • Willingness to participate in an ATI.
  • The following laboratory values obtained within 60 days prior to Step 1 entry:
  • Absolute neutrophil count (ANC) ≥1000 cells/mm^3
  • Hemoglobin ≥12.0 g/dL for men and ≥11.0 g/dL for women
  • Platelet count ≥125,000/mm^3
  • Estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m^2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) 2021 equation
  • Total bilirubin <1.5 x upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) (SGOT) <1.5 x ULN
  • Alanine aminotransferase (ALT) (SGPT) <1.5 x ULN
  • Alkaline phosphatase <1.5 x ULN
  • Hepatitis C virus (HCV) antibody negative result within 60 days prior to Step 1 entry or, for participants who are HCV antibody positive (based on testing performed at any time prior to Step 1 entry), a negative HCV RNA result obtained within 60 days prior to Step 1 entry.
  • Negative hepatitis B surface antigen (HBsAg) result obtained within 60 days prior to Step 1 entry.
  • Ability and willingness to restart ART following ATI according to study guidelines.
  • Completion of pre-entry leukapheresis or Large Volume Blood Draw (LVBD).

Who cannot join

  • Breastfeeding or plans to become pregnant within the next 36 months.
  • Known allergy/sensitivity or any hypersensitivity to components of study treatment or its formulation.
  • Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
  • Receipt of any investigational vaccine within 6 months prior to Step 1 entry.
  • Receipt of any vaccine within 14 days prior to Step 1 entry.
  • Prior receipt of anti-HIV broadly neutralizing antibody therapy.
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  • Prior receipt of a latency-reversing agent (LRA), whether licensed or investigational, unless reviewed and approved by the study's CMC.
  • AIDS-defining illness or opportunistic infection within 24 months prior to Step 1 entry.
  • Any clinically significant acute or chronic medical condition (such as autoimmune diseases), other than HIV infection, that in the opinion of the investigator would preclude participation.
  • Any history of an HIV-associated malignancy, including Kaposi's sarcoma and any type of lymphoma, or virus-associated cancers.
  • History of progressive multifocal leukoencephalopathy (PML).
  • Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery within 36 months prior to Step 1 entry or for whom such therapies are expected in the subsequent 12 months.
  • Receipt of cabotegravir-LA intramuscular (IM) or rilpivirine-LA IM or lenacapavir (SQ) within 24 months prior to Step 1 entry.
  • Resistance to one or more drugs in two or more ARV drug classes.
  • History of systemic corticosteroids (long-term use), immunosuppressive anti-cancer or other immunosuppressive agents, interleukins, systemic interferons, systemic chemotherapy, or other medications considered significant by the investigator within the 6 months prior to Step 1 entry.
  • History of or current clinical atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 ACC/AHA guidelines, including a previous diagnosis of any of the following:
  • Acute myocardial infarction
  • Acute coronary syndromes
  • Stable or unstable angina
  • Coronary or other arterial revascularization
  • Stroke
  • Transient ischemic attack
  • Peripheral arterial disease presumed to be of atherosclerotic origin
  • For participants aged ≥40: 10-year ASCVD risk score estimated by Pooled Cohort Equations >20% within 60 days prior to Step 1 entry.
  • Acute or serious illness requiring systemic treatment and/or hospitalization within 60 days prior to Step 1 entry.

Trial locations and contacts

13 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

13 sites in 3 countries

United States10 sites

  • The Ponce de Leon Center CRS

    Atlanta, Georgia, 30308-2012

    Ericka R. Patrick, 404-616-6313, erpatri@emory.edu

  • University of Colorado Hospital CRS (Site #6101)

    Aurora, Colorado, 80045

    Nicola Haakonsen, 303-724-0708, Nicola.haakonsen@cuanschutz.edu

  • Alabama CRS (Site # 31788)

    Birmingham, Alabama, 35222

    Heather Logan, 205-873-8686, heatherlogan@uabmc.edu

  • Massachusetts General Hospital CRS (MGH CRS)

    Boston, Massachusetts, 02114

    Amy Sbrolla, 617-726-5598, asbrolla@mgh.harvard.edu

  • Chapel Hill CRS

    Chapel Hill, North Carolina, 27599-7215

    Erin Hoffman, 919-843-0720, erin_hoffman@med.unc.edu

  • Northwestern University CRS (Site #2701)

    Chicago, Illinois, 60611

    Sherryl Wolfe, 312-695-4997, s-wolfe@northwestern.edu

  • Ohio State University CRS

    Columbus, Ohio, 43210

    Lindsay Summers, 614-293-8529, lindsay.summers@osumc.edu

  • Houston Advancing Research Team CRS (Site #31473)

    Houston, Texas, 77030

    Maria L. Martinez, 713-500-6718, maria.l.martinez@uth.tmc.edu

  • Penn Therapeutics CRS (Site #6201)

    Philadelphia, Pennsylvania, 19104

    Jason Kirschner, 347-674-1545, jason.kirschner@pennmedicine.upenn.edu

  • UCSD Antiviral Research Center CRS

    San Diego, California, 92103

    Steven Hendrickx, 619-543-6968, smhendrickx@health.ucsd.edu

Other trials in United States

Brazil2 sites

  • Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS (Site #12201)

    Porto Alegre, Rio Grande do Sul, 91350-180

    Rita d. Lira, +55 51-33572603, lrita@ghc.com.br

  • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site # 12101)

    Rio de Janeiro, 21040-360

    Brenda Hoagland, 55 21 38659122, brenda.hoagland@ini.fiocruz.br

Other trials in Brazil

Peru1 site

  • Barranco CRS

    Lima, 15063

    Consuelo Tristan, +51 1-206-7800 ext. 210, ctristan@impactaperu.org

Other trials in Peru

About this study

Official title: A Phase I 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

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).

Read the detailed description

This study is an open-label, two-arm, multi-step phase I study evaluating a combination of two broadly neutralizing antibodies (bNAbs), VRC07-523LS and PGT121.414.LS, in people living with HIV (PWH) who started antiretroviral therapy (ART) during acute/early infection. Participants will receive PGT121.414.LS and VRC07-523LS prior to undergoing an analytical treatment interruption (ATI). Participants will restart ART and continue follow-up after ATI to confirm viral suppression.

Participants will be screened for eligibility and have a pre-entry visit. After determination of eligibility, participants will be enrolled sequentially into Arm A (n=20) and then Arm B (n=20). The study consists of three steps including an analytic treatment interruption.

Arm A:

  • Step 1: Participants remain on ART and will receive an infusion of VRC07-523LS and PGT121.414.LS at study entry.
  • Step 2: Participants will interrupt their ART and receive a second infusion of VRC07-523LS 12 weeks after the initial infusion. Participants will be monitored closely for indications to resume ART.
  • Step 3: Upon meeting ART restart criteria in Step 2; participants will resume ART and be followed for up to 24 weeks.

Arm B:

  • Step 1: Participants remain on ART and will receive an infusion of VRC07-523LS and PGT121.414.LS at study entry and a second infusion of VRC07-523LS 12 weeks later.
  • Step 2: Participants will interrupt their ART. Participants will be monitored closely for indications to resume ART.
  • Step 3: Upon meeting ART restart criteria in Step 2; participants will resume ART and be followed for up to 24 weeks.

Participation in both arms will last up to 98 weeks.

Conditions
HIV-1-infection
Being tested
VRC07-523LS, PGT121.414.LS
Keywords
Suppressive Antiretroviral Therapy, Acute HIV-1, Broadly neutralizing antibody, Antibodies, HIV, HIV antibody, HIV Broadly neutralizing antibody

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VRC07-523LSBiological

    Administered by Intravenous (IV) infusion at Week 0 and 12 weeks later

  • PGT121.414.LSBiological

    Administered by IV infusion at Week 0

Study groups in NCT06987318
Study groupRoleWhat they receive
Arm AExperimentalNot described
Receives: Biological: VRC07-523LS; Biological: PGT121.414.LS
Arm BExperimentalNot described
Receives: Biological: VRC07-523LS; Biological: PGT121.414.LS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: At 62 weeks after Step 1 entry

Secondary outcomes (12)

  1. Change from Step 1 entry in cell-associated HIV-1 RNA/DNA ratio in total CD4+ cells

    To be measured focusing on unspliced and single spliced env mRNA and corresponding total and env DNA.

    Measured: Study entry through 72 weeks

  2. Change from Step 1 entry in low-level viremia measured by single copy assay (SCA)

    Measured: Study entry through 72 weeks

  3. Change from Step 1 entry in levels of intact proviral DNA in CD4+ T-cells

    Measured: Study entry through 72 weeks

  4. Change from Step 1 entry in levels of inducible infectious virus on CD4+ T-cells

    Measured: Study entry through 72 weeks

  5. Average number of weeks from ATI until meeting the virologic criteria for ART restart

    Measured: Week 2 through Week 72

  6. Proportion of participants with HIV-1 RNA<1000 copies/mL

    Measured: At 62 weeks

  7. Serum concentrations of VRC07-523LS and PGT121.414.LS at the time meeting the virologic criteria for ART restart

    Measured: At week 72

  8. Area Under the Curve (AUC) of VRC07-523LS and PGT121.414.LS

    Measured: Week 0 through End of Study, an average of 98 weeks

  9. IC50 for neutralization sensitivity of the HIV-1 envelope population to VRC07-523LS and PGT121.414.LS

    Measured: Week 0 through Week 72

  10. Proportion of participants who develop antibodies to VRC07-523LS and PGT121.414.LS

    Measured: Week 0 through End of Study, an average of 98 weeks

  11. CD4+ T-cells counts

    Measured: Week 0 through End of Study, an average of 98 weeks

  12. HIV-1-specific T-cell count measured by Intracellular Cytokine Staining

    Measured: Week 0 through Week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2025
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion29 Aug 2027 (estimated)
  4. Study completion7 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Enrollment will be opened to Arm A first. Once Arm A enrollment is completed, enrollment to Arm B will be opened.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06987318
Sponsor's protocol ID
A5389
Other IDs
38669
Status last verified
Oct 2026
First submitted
25 Apr 2025
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie results in the publication, after deidentification.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC07-523LS and PGT121.414.LS in people with HIV-1-infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States, Brazil, Peru. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06987318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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