VRC07-523LS + PGT121.414.LS for HIV

Recruiting at 12 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Must be taking: Protease inhibitors, Integrase inhibitors

Must not be taking: Corticosteroids, Chemotherapy, others

Disqualifiers: AIDS, Malignancy, ASCVD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for individuals living with HIV who started antiretroviral therapy (ART) early after infection. Participants must be willing to interrupt their current ART under close monitoring to test new treatments.

Inclusion Criteria

Ability and willingness of participant to provide informed consent

Specific laboratory values within 60 days prior to Step 1 entry

Hepatitis C virus (HCV) antibody negative result within 60 days prior to Step 1 entry or negative HCV RNA result for HCV antibody positive participants

Exclusion Criteria

I have not had an AIDS-defining illness or opportunistic infection in the last 2 years.

I do not have any serious health conditions that would stop me from joining.

Breastfeeding or plans to become pregnant within the next 36 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-entry

Participants have a pre-entry visit to confirm eligibility and prepare for study entry

1 week

1 visit (in-person)

Step 1

Participants remain on ART and receive an infusion of VRC07-523LS and PGT121.414.LS

12 weeks

2 visits (in-person)

Step 2

Participants interrupt ART and receive a second infusion of VRC07-523LS, monitored for ART resumption

12 weeks

2 visits (in-person)

Step 3

Participants resume ART upon meeting criteria and are followed for viral suppression

24 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 98 weeks

Treatment Details

Interventions

• PGT121.414.LS
• VRC07-523LS

Trial Overview The study tests the safety and effectiveness of two human monoclonal antibodies, VRC07-523LS and PGT121.414.LS, in controlling HIV without regular ART during a monitored treatment pause.

Participant Groups

Group I: Arm B Experimental Treatment 2 Interventions

Group II: Arm A Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

Monogram Biosciences

Collaborator