MGD020 + MGD014 for HIV

Recruiting at 2 trial locations

Overseen By Global Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: MacroGenics

Must be taking: Antiretrovirals

Must not be taking: HIV-1 entry inhibitors

Disqualifiers: HIV-1 vaccine, Active infection, others

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

Compensation: Varies

Number of Visits: 3

17 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new drugs, MGD020 and MGD014, in people with HIV who are already on treatment. These drugs help the immune system find and kill HIV-infected cells by acting as a bridge between immune cells and the virus.

Will I have to stop taking my current medications?

No, you will not have to stop taking your current antiretroviral therapy (ART) medications. The trial requires participants to continue their ART throughout the study.

Who Is on the Research Team?

Pepi Pencheva, MD

Principal Investigator

MacroGenics

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70 with well-controlled HIV on antiretroviral therapy (ART) for at least 24 months, having a viral load under 50 copies/mL. They must have stable health, no recent serious infections or COVID-19, and not be in other studies. Participants should agree to contraception use during the study and for four months after.

Inclusion Criteria

HIV-1 infection documented by rapid HIV test or HIV enzyme or chemiluminescence immunoassay and confirmed by a different second test

I have been on HIV medication for at least 2 years and will continue it during the study.

Plasma HIV-1 RNA viral load: < 50 copies/mL at 2 time points within 24 months prior to screening (1 time point within 12 months prior to screening), < 50 copies/mL at screening, and not ≥ 50 copies/mL on 2 consecutive time points within 24 months nor > 1000 copies/mL at any time within 6 months prior to screening

Exclusion Criteria

I haven't had any HIV-1 vaccines or treatments in the last 6 months, except MGD014 or MGD020.

I haven't needed IV treatment for an infection in the last 7 days.

Participation in another investigational clinical research study within 60 days prior to screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Part 1A: Dose Escalation

Participants receive a single dose of MGD020 with a 2-week safety observation period before dose escalation

Up to 43 days

Multiple visits for dose administration and safety monitoring

Part 1B: Combination Dose Escalation

Participants receive a single dose of MGD020 and a fixed dose of MGD014, with dose escalation to determine MTD or MAD

Up to 43 days

Multiple visits for dose administration and safety monitoring

Part 2: Multi-dose Expansion

Participants receive the MTD or MAD of MGD020 and a fixed dose of MGD014 every 2 weeks for 3 doses over 4 weeks

4 weeks

3 visits for dose administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MGD014
• MGD020

Trial Overview The trial tests MGD020 alone or combined with MGD014 in people with HIV. It's an early-phase study assessing safety, tolerability, how the body processes these drugs (pharmacokinetics), immune response (immunogenicity), and drug effects (pharmacodynamics). The treatment involves different doses of MGD020 followed by combination doses with MGD014.

How Is the Trial Designed?

Group I: Part 2: MGD020 and MGD014 Experimental Treatment 2 Interventions

Multiple doses of MGD020 and MGD014

Group II: Part 1B: MTD/MAD MGD020 and MGD014 Experimental Treatment 2 Interventions

Single dose MGD020 and MGD014

Group III: Part 1B: MTD/MAD -1 MGD020 and MGD014 Experimental Treatment 2 Interventions

Single dose MGD020 and MGD014

Group IV: Part 1A: Dose level 6 Experimental Treatment 1 Intervention

Single dose MGD020

Group V: Part 1A: Dose level 5 Experimental Treatment 1 Intervention

Single dose MGD020

Group VI: Part 1A: Dose level 4 Experimental Treatment 1 Intervention

Single dose MGD020

Group VII: Part 1A: Dose level 3 Experimental Treatment 1 Intervention

Single dose MGD020

Group VIII: Part 1A: Dose level 2 Experimental Treatment 1 Intervention

Single dose MGD020

Group IX: Part 1A: Dose level 1 Experimental Treatment 1 Intervention

Single dose MGD020

Who Is Running the Clinical Trial?

MacroGenics

Lead Sponsor

Trials

51

Recruited

5,400+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials

3,361

Recruited

5,516,000+