Antibodies for HIV

Not yet recruiting at 7 trial locations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is testing a lab-made antibody called ePGT121v1-LS that targets a specific part of HIV. Researchers will give it by vein (IV) and under the skin (SC), both on its own and together with two other antibodies, VRC07-523LS and PGDM1400LS, which target different parts of the virus. They will assess safety and side effects, determine the right dose, study how the body processes the drug (pharmacokinetics or PK), and measure how well it neutralizes HIV in the blood (serum neutralizing activity). The expectation is that ePGT121v1-LS, whether given alone or with PGDM1400LS and VRC07-523LS, by IV or SC, will be safe in generally healthy adults and that the antibodies will not interfere with each other when used together.

Approximately 83 volunteers in overall good health and without HIV-1 will be enrolled into two parts (A and B).

Part A has six groups. In Groups 1-3, participants will get ePGT121v1-LS given by IV at one of three dose levels: 5 mg/kg, 20 mg/kg, or 40 mg/kg. In Groups 4-6, participants will receive three antibodies-first ePGT121v1-LS, then PGDM1400LS and VRC07-523LS-given by IV at two separate visits that are 24 weeks apart. The total study duration for participants in Part A is 48 weeks of scheduled clinic visits.

Part B has two groups. In Group 7, people will get ePGT121v1-LS as SC shots at two visits 12 weeks apart. Each visit will give a total of 375 mg, split into three injections of 125 mg each. In Group 8, people will also have two visits 12 weeks apart and will receive three antibodies as SC shots in this order: first ePGT121v1-LS (125 mg), then PGDM1400LS (100 mg), and then VRC07-523LS (100 mg). The total study duration for participants in Part B is 24 weeks of scheduled clinic visits.

Are You a Good Fit for This Trial?

This trial is for generally healthy adults without HIV-1. It's testing a new antibody treatment given by vein (IV) or under the skin (SC). Participants will be divided into groups to receive different doses and combinations of antibodies over several weeks.

Inclusion Criteria

In good overall health based on medical history, physical exam, and screening lab tests

Women who could become pregnant agree to use effective birth control for sex that could lead to pregnancy starting at least 21 days before enrollment and continuing through the last study visit

If a woman who could become pregnant: negative pregnancy test within 72 hours before the first study treatment. Women with specific medical history do not need pregnancy testing

Exclusion Criteria

Previously received an HIV vaccine in a vaccine trial (case by case decision)

Autoimmune disease that is not mild, stable, and uncomplicated

I have a diagnosed bleeding disorder.

What Are the Treatments Tested in This Trial?

Interventions

• ePGT121v1-LS
• PGDM1400LS
• VRC07-523LS

Trial Overview

The study tests ePGT121v1-LS alone or with PGDM1400LS and VRC07-523LS, administered either IV or SC. It aims to find safe dosages, understand how the body processes these drugs, and their effectiveness in neutralizing HIV.

How Is the Trial Designed?

Group I: Part B: Group 8 Experimental Treatment 3 Interventions

ePGT121v1-LS 125 mg + PGDM1400LS 100 mg + VRC07-523LS 100 mg to be administered via SC injection sequentially in this order at Week 0 and Week 12

Group II: Part B: Group 7 Experimental Treatment 1 Intervention

ePGT121v1-LS 375 mg (3 injections of 125 mg each) to be administered via subcutaneous (SC) injection at Week 0 and Week 12

Group III: Part A: Group 6 Experimental Treatment 3 Interventions

ePGT121v1-LS 40 mg/kg + PGDM1400LS 40 mg/kg + VRC07-523LS 40 mg/kg to be administered via IV infusion sequentially in this order at Week 0 and Week 24

Group IV: Part A: Group 5 Experimental Treatment 3 Interventions

ePGT121v1-LS 20 mg/kg + PGDM1400LS 20 mg/kg + VRC07-523LS 20 mg/kg to be administered via IV infusion sequentially in this order at Week 0 and Week 24

Group V: Part A: Group 4 Experimental Treatment 3 Interventions

ePGT121v1-LS 5 mg/kg + PGDM1400LS 5 mg/kg + VRC07-523LS 5 mg/kg to be administered via IV infusion sequentially in this order at Week 0 and Week 24

Group VI: Part A: Group 3 Experimental Treatment 1 Intervention

ePGT121v1-LS 40 mg/kg to be administered via IV infusion at Week 0 and Week 24

Group VII: Part A: Group 2 Experimental Treatment 1 Intervention

ePGT121v1-LS 20 mg/kg to be administered via IV infusion at Week 0 and Week 24

Group VIII: Part A: Group 1 Experimental Treatment 1 Intervention

ePGT121v1-LS 5 mg/kg to be administered via intravenous (IV) infusion at Week 0 and Week 24

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials

3,361

Recruited

5,516,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+