MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy

A Phase 1 study testing MGD014 in people with HIV-1-infection, run by MacroGenics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a Phase 1, open-label single-center study to determine the safety of MGD014 in participants with human immunodeficiency virus (HIV) infection on stable suppressive antiretroviral therapy (ART). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: HIV-1-infection
What is being tested?: MGD014
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 25 Sep 2018to 28 Sep 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability and willingness of participant to provide written informed consent.
HIV-1 infection, documented by any FDA-approved rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
On a potent, stable, continuous ART regimen for ≥ 24 months prior to Screening.
Plasma HIV-1 RNA < 50 copies/mL at two time points in the previous 12 months prior to screening (one time point can be screening) and never ≥ 50 copies/mL on 2 consecutive time points in the last 24 months.
Adequate organ function based on acceptable laboratory parameters.

Who cannot join

Women of childbearing potential defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or menopause.
History or other evidence of severe illness, immunodeficiency other than HIV, or any other condition that would make the potential participant unsuitable for study.
History or other evidence of any condition or process for which signs or symptoms could be confused with reactions to MGD014.
History of any HIV immunotherapy or HIV vaccine except for MGD014 within 12 months prior to screening.
History of clinically significant cardiovascular disease, severe allergic reactions, malignancy (except non-melanoma skin cancer) within 5 years, seizure disorder within 2 years, organ/tissue transplant, autoimmune disease, unstable asthma, bleeding disorder.
Evidence of active viral, or antifungal treatment within 7 days prior to the initiation of study drug

Show all 11Show fewer

Active, asymptomatic, or suspected COVID-19/SARS-CoV-2 infection.
Active, untreated syphilis.
Use of blood products, cytokine therapy, growth-stimulating factors, cytotoxic chemotherapy or investigational therapy within 90 days.
Current use of the antivirals maraviroc and/or enfuvirtide.
Any vaccination with exception of flu vaccine within 30 days of screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Immunologic and Virologic Responses of MGD014 Therapy in HIV-Infected Individuals on Suppressive Antiretroviral Therapy

Read the detailed description

Eligible participants will be maintained on ART and receive either one infusion (Part 1) or multiple infusions of MGD014 (Part 2). Part 1 is a single ascending dose study with a 1+3 design for the first 2 dose cohorts, and a 3+3 design with staggered accrual for the 6 higher dose cohorts, with an aim of determining the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of ascending doses up to either the Optimal Biologic Dose (OBD) or the maximum administered dose (MAD).

Part 2 is a multi-dose expansion cohort with MGD014 administered at the OBD, as determined in Part 1. In Part 2, additional assessments on the effects of MGD014 on HIV latent infection parameters will be evaluated.

Conditions: HIV-1-infection
Being tested: MGD014
Keywords: HIV, Latent HIV-1 infection, HIV therapy, antibody-based therapy

What participants receive

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

MGD014Biological
HIV-1 x CD3 bispecific DART molecule

Study groups in NCT03570918
Study group	Role	What they receive
MGD014 0.1 micrograms/kilogram (mcg/kg)	Experimental	a single 2-hour infusion Receives: Biological: MGD014
MGD014 0.3 mcg/kg	Experimental	a single 2-hour infusion Receives: Biological: MGD014
MGD014 1.0 mcg/kg	Experimental	a single 2-hour infusion Receives: Biological: MGD014
MGD014 3.0 mcg/kg	Experimental	a single 2-hour infusion Receives: Biological: MGD014
MGD014 10.0 mcg/kg	Experimental	a single 2-hour infusion Receives: Biological: MGD014
MGD014 30.0 mcg/kg	Experimental	a single 2-hour infusion Receives: Biological: MGD014
MGD014 100.0 mcg/kg	Experimental	a single 2-hour infusion Receives: Biological: MGD014
MGD014 300.0 mcg/kg	Experimental	a single 2-hour infusion Receives: Biological: MGD014
MGD014 300.0 mcg/kg multiple doses	Experimental	2-hour infusion every 2 weeks for 3 infusions Receives: Biological: MGD014

What is being measured

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

Number of Participants With Treatment-Emerging Adverse Events
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.
Measured: up to 77 days

Secondary outcomes (9)

AUC Inf: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity of MGD014
AUCinf, area under the concentration-time curve from the time of dose extrapolated to time infinity and reflects total drug exposure
Measured: Study Day 0 to 42
Cmax: Maximum Plasma Concentration
Cmax is the maximum (or peak) serum concentration of a drug in the body after the drug has been administered
Measured: Study Day 0
Tmax: Time to Maximum Concentration
Tmax is the time it takes a drug to reach the maximum concentration
Measured: Study Day 0
Ctrough: Trough Level Concentration
a trough level or trough concentration (Ctrough) is the concentration reached by a drug immediately before the next dose is administered,
Measured: Study Day 14
Clearance
Total body clearance of the drug from plasma of MGD014
Measured: Study Day 0 to 42
Vz: Terminal Phase Volume of Distribution of MGD014
The ratio of the total quantity of drug in the body to drug plasma concentration during the elimination
Measured: Study Day 1, 2, 7, 14, 21, 28, and 42 (single infusion) and Study Day 1, 3, 14, 28, 42, and 77 (multiple infusions)
Terminal Half Life of MGD014
The half-life is the amount of time required for 50% of the drug to be removed from the body
Measured: Study Day 0 to Study Day 42
Number of Participants That Developed Antidrug Antibodies to MGD014
Number of participants with antidrug antibodies to MGD014
Measured: Study Day 1, 14, 28 and 42 (single infusion) and Study Day 1, 14, 28 and 77 (multiple infusions)
Number of Participants With Increased Cytokine Levels
Number of participants with increased cytokine levels from baseline after MGD014 administration. This safety measure compares serum cytokine levels obtained prior to dosing with levels obtained after dosing. Increased cytokines can be a measure of T-cell activation in response to MGD014 binding. Cytokines analyzed included interferon-gamma, tumor necrosis factor-alpha, interleukin (IL)2, IL-5, IL-6, and IL-10.
Measured: Study Day 1, 2 and 7 (single infusion) and Study Day 1, 3, 14 and 28 (multiple infusions)

Timeline

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

25 Sep 201828 Sep 2021

First posted27 Jun 2018
Study start25 Sep 2018
Primary completion28 Sep 2021
Study completion28 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV-1-infectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Open-label dose-escalation study
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03570918
Sponsor's protocol ID: CP-MGD014-01
Other IDs: 272201500032C-2-0-1
Status last verified: Aug 2022
First submitted: 18 Jun 2018
Last updated: 2 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV-1-infection trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Evaluate the Safety, Immunologic and Virologic Responses of MGD014 Therapy in HIV-Infected Individuals on Suppressive Antiretroviral Therapy
ClinicalTrials.gov ID: NCT03570918
Acronym / sponsor ID: CP-MGD014-01
Conditions: HIV-1-infection
Keywords: HIV, Latent HIV-1 infection, HIV therapy, antibody-based therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: MacroGenicsIndustry (pharma, biotech, devices)
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 25 Sep 2018 (actual)
Primary completion: 28 Sep 2021 (actual)
Study completion: 28 Sep 2021 (actual)
First posted: 27 Jun 2018 (actual)
Results: Posted 2 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 9
Model description: Open-label dose-escalation study

Arm	Type	Receives
MGD014 0.1 micrograms/kilogram (mcg/kg)	Experimental	Biological: MGD014a single 2-hour infusion
MGD014 0.3 mcg/kg	Experimental	Biological: MGD014a single 2-hour infusion
MGD014 1.0 mcg/kg	Experimental	Biological: MGD014a single 2-hour infusion
MGD014 3.0 mcg/kg	Experimental	Biological: MGD014a single 2-hour infusion
MGD014 10.0 mcg/kg	Experimental	Biological: MGD014a single 2-hour infusion
MGD014 30.0 mcg/kg	Experimental	Biological: MGD014a single 2-hour infusion
MGD014 100.0 mcg/kg	Experimental	Biological: MGD014a single 2-hour infusion
MGD014 300.0 mcg/kg	Experimental	Biological: MGD014a single 2-hour infusion
MGD014 300.0 mcg/kg multiple doses	Experimental	Biological: MGD0142-hour infusion every 2 weeks for 3 infusions

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Ability and willingness of participant to provide written informed consent.
HIV-1 infection, documented by any FDA-approved rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
On a potent, stable, continuous ART regimen for ≥ 24 months prior to Screening.
Plasma HIV-1 RNA < 50 copies/mL at two time points in the previous 12 months prior to screening (one time point can be screening) and never ≥ 50 copies/mL on 2 consecutive time points in the last 24 months.
Adequate organ function based on acceptable laboratory parameters.

Key exclusion criteria (11 listed)

Women of childbearing potential defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or menopause.
History or other evidence of severe illness, immunodeficiency other than HIV, or any other condition that would make the potential participant unsuitable for study.
History or other evidence of any condition or process for which signs or symptoms could be confused with reactions to MGD014.
History of any HIV immunotherapy or HIV vaccine except for MGD014 within 12 months prior to screening.
History of clinically significant cardiovascular disease, severe allergic reactions, malignancy (except non-melanoma skin cancer) within 5 years, seizure disorder within 2 years, organ/tissue transplant, autoimmune disease, unstable asthma, bleeding disorder.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MGD014HIV-1 x CD3 bispecific DART molecule	Biological	MGD014 0.1 micrograms/kilogram (mcg/kg), MGD014 0.3 mcg/kg, MGD014 1.0 mcg/kg, MGD014 10.0 mcg/kg, MGD014 100.0 mcg/kg, MGD014 3.0 mcg/kg, MGD014 30.0 mcg/kg, MGD014 300.0 mcg/kg, MGD014 300.0 mcg/kg multiple doses

Primary outcome

Number of Participants With Treatment-Emerging Adverse Events
Time frame: up to 77 days
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of study drug administration through the End of Study visit.

9 secondary outcomes

AUC Inf: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity of MGD014
Time frame: Study Day 0 to 42
Cmax: Maximum Plasma Concentration
Time frame: Study Day 0
Tmax: Time to Maximum Concentration
Time frame: Study Day 0
Ctrough: Trough Level Concentration
Time frame: Study Day 14
Clearance
Time frame: Study Day 0 to 42
Vz: Terminal Phase Volume of Distribution of MGD014
Time frame: Study Day 1, 2, 7, 14, 21, 28, and 42 (single infusion) and Study Day 1, 3, 14, 28, 42, and 77 (multiple infusions)
Terminal Half Life of MGD014
Time frame: Study Day 0 to Study Day 42
Number of Participants That Developed Antidrug Antibodies to MGD014
Time frame: Study Day 1, 14, 28 and 42 (single infusion) and Study Day 1, 14, 28 and 77 (multiple infusions)
Number of Participants With Increased Cytokine Levels
Time frame: Study Day 1, 2 and 7 (single infusion) and Study Day 1, 3, 14 and 28 (multiple infusions)

Results and safety

Results posted to the registry on 2 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MGD014 0.1 Micrograms/Kilogram (mcg/kg)	1	1
MGD014 0.3 mcg/kg	1	1
MGD014 1.0 mcg/kg	4	4
MGD014 3.0 mcg/kg	3	3
MGD014 10.0 mcg/kg	3	3
MGD014 30.0 mcg/kg	3	3
MGD014 100.0 mcg/kg	3	3
MGD014 300.0 mcg/kg	3	3
MGD014 300 mcg/kg Multiple Doses	0	0

Primary outcome: Number of Participants With Treatment-Emerging Adverse Events

Time frame: up to 77 days. Count of participants. Unit: Participants

Measure	MGD014 0.1 Micrograms/Kilogram (mcg/kg) n = 1	MGD014 0.3 mcg/kg n = 1	MGD014 1.0 mcg/kg n = 4	MGD014 3.0 mcg/kg n = 3	MGD014 10.0 mcg/kg n = 3	MGD014 30.0 mcg/kg n = 3	MGD014 100.0 mcg/kg n = 3	MGD014 300.0 mcg/kg n = 3	MGD014 300.0 mcg/kg Multiple Doses n = 3
Value	1	1	4	3	2	2	2	3	2

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 19 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MGD014 0.1 mcg/kg	0 of 1 (0%)	1 of 1 (100%)	0 of 1
MGD014 0.3 mcg/kg	0 of 1 (0%)	1 of 1 (100%)	0 of 1
MGD014 1.0 mcg/kg	0 of 4 (0%)	4 of 4 (100%)	0 of 4
MGD014 3.0 mcg/kg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
MGD014 10.0 mcg/kg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
MGD014 30 mcg/kg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
MGD014 100 mcg/kg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
MGD014 300 mcg/kg	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Multiple Dose MGD014 300 mcg/kg	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for HIV-1-infection

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chief Medical Officer study director

MacroGenics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MGD014 in people with HIV-1-infection, run by MacroGenics at 1 site in United States.

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 5 inclusion and 11 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: finished, as of the sponsor's last update on 2 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Yes. Results are posted in the registry (first posted 2 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emerging Adverse Events (time frame: up to 77 days). 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 NCT03570918.

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 2 Sep 2022.