17 Participants Needed

MGD020 + MGD014 for HIV

Recruiting at 2 trial locations
GT
Overseen ByGlobal Trial Manager
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: MacroGenics
Must be taking: Antiretrovirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

PP

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
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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
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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?
9Treatment groups
Experimental Treatment
Group I: Part 2: MGD020 and MGD014Experimental Treatment2 Interventions
Group II: Part 1B: MTD/MAD MGD020 and MGD014Experimental Treatment2 Interventions
Group III: Part 1B: MTD/MAD -1 MGD020 and MGD014Experimental Treatment2 Interventions
Group IV: Part 1A: Dose level 6Experimental Treatment1 Intervention
Group V: Part 1A: Dose level 5Experimental Treatment1 Intervention
Group VI: Part 1A: Dose level 4Experimental Treatment1 Intervention
Group VII: Part 1A: Dose level 3Experimental Treatment1 Intervention
Group VIII: Part 1A: Dose level 2Experimental Treatment1 Intervention
Group IX: Part 1A: Dose level 1Experimental Treatment1 Intervention

Find a Clinic Near You

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+
Unbiased ResultsWe believe in providing patients with all the options.
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