Human Immunodeficiency Virus I InfectionPhase 1NCT05261191

A Study of MGD020 Alone or Combined With MGD014 in Persons With HIV-1 on Antiretroviral Therapy

A Phase 1 study testing MGD020 and MGD014 in people with Human Immunodeficiency Virus I Infection and Immunodeficiency Virus Type 1, Human, run by MacroGenics at 3 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Human Immunodeficiency Virus I Infection, Immunodeficiency Virus Type 1, Human, Human Immunodeficiency Virus Type 1
What is being tested?: MGD020 and MGD014
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 3 sitesUnited States
Study dates: 26 Sep 2022to 29 May 2024
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged ≥ 18 years and ≤ 70 years of age and able to provide informed consent
HIV-1 infection documented by rapid HIV test or HIV enzyme or chemiluminescence immunoassay and confirmed by a different second test.
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), and
< 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

Show all 10Show fewer

On continuous antiretroviral therapy (ART) for at least 24 months prior to screening and must continue ART throughout the study.
CD4 cell count > 350 cells/mm3 at screening
Acceptable laboratory values related to bone marrow, kidney and liver function.
Individuals of childbearing potential must agree to use highly effective forms of contraception throughout the study through 6 months after the last dose of MGD014.

Who cannot join

History of any HIV-1 vaccine or HIV-1 immunotherapy, except MGD014 or MGD020, within 6 months prior to screening.
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient.
Active viral, bacterial, or systemic fungal infection requiring intravenous antibiotic, antiviral, or antifungal treatment within 7 days prior to the initiation of study drug.
Active coronavirus disease 19 (COVID-19)/severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Participation in another investigational clinical research study within 60 days prior to screening.
History of virologic failure on an ART regimen containing FDA-approved HIV-1 entry inhibitors (maraviroc, enfuvirtide, and/or ibalizumab). Virologic failure is defined as a confirmed plasma HIV-1 RNA ≥ 150 copies/mL following assessment of drug adherence, repeat HIV-1 RNA testing with continued treatment, and/or resistance testing

Trial locations and contacts

3 sites in 1 country.

United States3 sites

UNC Hospital - Chapel Hill
Chapel Hill, North Carolina, 27599
Case Western Reserve University Hospital
Cleveland, Ohio, 44106
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029

Other trials in United States

About this study

Official title: A Phase 1 Study of MGD020 as a Single Agent or in Combination With MGD014 in Persons With HIV-1 on Antiretroviral Therapy

Study CP-MGD020-01 is a phase 1, open-label, dose-escalation, and multi-dose expansion study of MGD020 as a single agent or in combination with MGD014 in persons with HIV-1 (PWH) on antiretroviral therapy (ART). The study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of the study drugs. The study consists of 3 parts (Part 1A, Part 1B, and Part 2). The participant's standard of care ART regimen is continued throughout the study period.

MGD020 is a bispecific DART® molecule that binds CD3 and gp41 subunit of HIV-1 envelope. MGD014 is a bispecific DART® molecule that binds CD3 and gp120 subunit of HIV-1 envelope. These DART molecules redirect CD3+ T lymphocytes to kill HIV-1-infected CD4+ T cells.

Part 1A evaluates groups of participants given a single dose of MGD020. A 2-week safety period is observed prior to escalation to the next dose level. Dose escalation continues until either the maximum tolerated dose (MTD) or maximum administered dose (MAD) is determined.

Part 1B begins after the end of Part 1A. Part 1B evaluates groups of participants given a single dose of the MGD020 MTD or MAD from Part 1A and a fixed dose of of MGD014. The first group will be treated with a single dose of MGD020, at a dose determined to be one dose lower than the single-agent MTD/MAD from Part 1A, and a single 300 mcg/kg dose of MGD014. Dose escalation proceeds until either the MTD or MAD is determined.

Part 2 begins after the end of Part 1B. Part 2 is a multi-dose expansion group. Each participant will receive the MTD or MAD of MGD020 from Part 1B and a fixed dose of MGD014 from Part 1B, administered every 2 weeks (Q2W) for 3 combination doses over 4 weeks. Up to 6 participants may be enrolled in Part 2.

Conditions: Human Immunodeficiency Virus I Infection, Immunodeficiency Virus Type 1, Human, Human Immunodeficiency Virus Type 1
Being tested: MGD020, MGD014
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

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

MGD020Biological
MGD020 is a bispecific DART molecule that binds CD3 and gp41 subunit of HIV-1 envelope.
MGD014Biological
MGD014 is a bispecific DART molecule that binds CD3 and gp120 subunit of HIV-1 envelope.

Study groups in NCT05261191
Study group	Role	What they receive
Part 1A: Dose level 1	Experimental	Single dose MGD020 Receives: Biological: MGD020
Part 1A: Dose level 2	Experimental	Single dose MGD020 Receives: Biological: MGD020
Part 1A: Dose level 3	Experimental	Single dose MGD020 Receives: Biological: MGD020
Part 1A: Dose level 4	Experimental	Single dose MGD020 Receives: Biological: MGD020
Part 1A: Dose level 5	Experimental	Single dose MGD020 Receives: Biological: MGD020
Part 1A: Dose level 6	Experimental	Single dose MGD020 Receives: Biological: MGD020
Part 1B: MTD/MAD -1 MGD020 and MGD014	Experimental	Single dose MGD020 and MGD014 Receives: Biological: MGD020; Biological: MGD014
Part 1B: MTD/MAD MGD020 and MGD014	Experimental	Single dose MGD020 and MGD014 Receives: Biological: MGD020; Biological: MGD014
Part 2: MGD020 and MGD014	Experimental	Multiple doses of MGD020 and MGD014 Receives: Biological: MGD020; Biological: MGD014

What is being measured

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

Number and Types of Adverse Events (AEs), Including Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 Alone in Part 1A
Observation of side effects determines the highest safe dose for further study
Measured: Throughout the study, up to 43 days
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 1B.
Observation of side effects determines the highest safe dose for further study
Measured: Throughout the study, up to 43 days
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 2.
Observation of side effects determines the highest safe dose for further study
Measured: Throughout the study, up to 81 days.

Secondary outcomes (15)

Mean Maximum Concentration of MGD020
The highest concentration of MGD020 at the end of the infusion
Measured: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Mean Maximum Concentration of MGD014
The highest concentration of MGD014 at the end of the infusion (Cmax).
Measured: Throughout the study, up to 43 days for Part 1B, and up to 78 days for Part 2
Mean Time to Maximal Concentration of MGD020
The amount of time required to get maximum concentration of MGD020
Measured: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Mean Time to Maximal Concentration of MGD014
The amount of time required to get maximum concentration of MGD014
Measured: Throughout the study, up to 43 days for Part 1B, and up to 78 days for Part 2
Mean Area Under the Concentration-time Curve (AUC) of MGD020
Total body exposure to MGD020
Measured: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Mean AUC of MGD014
Total body exposure to MGD014
Measured: Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2
Mean Half-life of MGD020
The amount of time needed for the body to clear half of the dose of MGD020
Measured: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Mean Half-life of MGD014
The amount of time needed for the body to clear half of the dose of MGD014
Measured: Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2
Mean Volume of Distribution at Steady State (Vss) of MGD020
This parameter measures how much of the drug remains in the bloodstream or is distributed to body tissues.
Measured: Throughout the study, up to 78 days for Part 2
Mean Volume of Distribution at Steady State of MGD014
This parameter measures how much of the drug remains in the bloodstream or is distributed to body tissues.
Measured: Throughout the study, up to 78 days for Part 2
Mean Clearance of MGD020
Total body clearance of the drug from plasma of MGD020
Measured: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Mean Clearance of MGD014
Total body clearance of the drug from plasma of MGD014
Measured: Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2
Number of Participants With Elevations in Serum Cytokine Levels of IFN-γ, IL-2, IL-5, IL-6, IL-10, or TNF-α
Measured: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2.
Anti-drug Antibody Formation to MGD020
Number of patients who develop antibodies against MDG020
Measured: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Anti-drug Antibody Formation to MGD014
Number of patients who develop antibodies against MDG014
Measured: Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2

Timeline

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

26 Sep 202229 May 2024

First posted2 Mar 2022
Study start26 Sep 2022
Primary completion29 May 2024
Study completion29 May 2024

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 Human Immunodeficiency Virus I 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
Masking: None (open label)
Enrolment: 17 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05261191
Sponsor's protocol ID: CP-MGD020-01
Other IDs: 272201500032C-P00008-9999-1
Status last verified: Mar 2025
First submitted: 18 Feb 2022
Last updated: 28 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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

RecruitingObservational study
Evaluation of Patients With HAM/TSP
HTLV-I Infection, Tropical Spastic Paraparesis
RecruitingPhase 1
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
HIV Infections
RecruitingPhase 1/2
Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
HIV, Hematologic Malignancies
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis

All Human Immunodeficiency Virus I Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study of MGD020 as a Single Agent or in Combination With MGD014 in Persons With HIV-1 on Antiretroviral Therapy
ClinicalTrials.gov ID: NCT05261191
Acronym / sponsor ID: CP-MGD020-01
Conditions: Human Immunodeficiency Virus I Infection, Immunodeficiency Virus Type 1, Human, Human Immunodeficiency Virus Type 1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 17 participants (actual)
Lead sponsor: MacroGenicsIndustry (pharma, biotech, devices)
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services
Study start: 26 Sep 2022 (actual)
Primary completion: 29 May 2024 (actual)
Study completion: 29 May 2024 (actual)
First posted: 2 Mar 2022 (actual)
Results: Posted 28 Mar 2025

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
Part 1A: Dose level 1	Experimental	Biological: MGD020Single dose MGD020
Part 1A: Dose level 2	Experimental	Biological: MGD020Single dose MGD020
Part 1A: Dose level 3	Experimental	Biological: MGD020Single dose MGD020
Part 1A: Dose level 4	Experimental	Biological: MGD020Single dose MGD020
Part 1A: Dose level 5	Experimental	Biological: MGD020Single dose MGD020
Part 1A: Dose level 6	Experimental	Biological: MGD020Single dose MGD020
Part 1B: MTD/MAD -1 MGD020 and MGD014	Experimental	Biological: MGD020, Biological: MGD014Single dose MGD020 and MGD014
Part 1B: MTD/MAD MGD020 and MGD014	Experimental	Biological: MGD020, Biological: MGD014Single dose MGD020 and MGD014
Part 2: MGD020 and MGD014	Experimental	Biological: MGD020, Biological: MGD014Multiple doses of MGD020 and MGD014

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Aged ≥ 18 years and ≤ 70 years of age and able to provide informed consent
HIV-1 infection documented by rapid HIV test or HIV enzyme or chemiluminescence immunoassay and confirmed by a different second test.
Plasma HIV-1 RNA viral load
On continuous antiretroviral therapy (ART) for at least 24 months prior to screening and must continue ART throughout the study.
CD4 cell count > 350 cells/mm3 at screening

Key exclusion criteria (6 listed)

History of any HIV-1 vaccine or HIV-1 immunotherapy, except MGD014 or MGD020, within 6 months prior to screening.
History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient.
Active viral, bacterial, or systemic fungal infection requiring intravenous antibiotic, antiviral, or antifungal treatment within 7 days prior to the initiation of study drug.
Active coronavirus disease 19 (COVID-19)/severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
Participation in another investigational clinical research study within 60 days prior to screening.

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
MGD020MGD020 is a bispecific DART molecule that binds CD3 and gp41 subunit of HIV-1 envelope.	Biological	Part 1A: Dose level 1, Part 1A: Dose level 2, Part 1A: Dose level 3, Part 1A: Dose level 4, Part 1A: Dose level 5, Part 1A: Dose level 6, Part 1B: MTD/MAD -1 MGD020 and MGD014, Part 1B: MTD/MAD MGD020 and MGD014, Part 2: MGD020 and MGD014
MGD014MGD014 is a bispecific DART molecule that binds CD3 and gp120 subunit of HIV-1 envelope.	Biological	Part 1B: MTD/MAD -1 MGD020 and MGD014, Part 1B: MTD/MAD MGD020 and MGD014, Part 2: MGD020 and MGD014

Primary outcome

Number and Types of Adverse Events (AEs), Including Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 Alone in Part 1A
Time frame: Throughout the study, up to 43 days
Observation of side effects determines the highest safe dose for further study
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 1B.
Time frame: Throughout the study, up to 43 days
Observation of side effects determines the highest safe dose for further study
Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 2.
Time frame: Throughout the study, up to 81 days.
Observation of side effects determines the highest safe dose for further study

15 secondary outcomes

Mean Maximum Concentration of MGD020
Time frame: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Mean Maximum Concentration of MGD014
Time frame: Throughout the study, up to 43 days for Part 1B, and up to 78 days for Part 2
Mean Time to Maximal Concentration of MGD020
Time frame: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Mean Time to Maximal Concentration of MGD014
Time frame: Throughout the study, up to 43 days for Part 1B, and up to 78 days for Part 2
Mean Area Under the Concentration-time Curve (AUC) of MGD020
Time frame: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Mean AUC of MGD014
Time frame: Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2
Mean Half-life of MGD020
Time frame: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Mean Half-life of MGD014
Time frame: Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2
Mean Volume of Distribution at Steady State (Vss) of MGD020
Time frame: Throughout the study, up to 78 days for Part 2
Mean Volume of Distribution at Steady State of MGD014
Time frame: Throughout the study, up to 78 days for Part 2
Mean Clearance of MGD020
Time frame: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Mean Clearance of MGD014
Time frame: Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2
Number of Participants With Elevations in Serum Cytokine Levels of IFN-γ, IL-2, IL-5, IL-6, IL-10, or TNF-α
Time frame: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2.
Anti-drug Antibody Formation to MGD020
Time frame: Throughout the study, up to 43 days for Parts 1A and 1B, and up to 78 days for Part 2
Anti-drug Antibody Formation to MGD014
Time frame: Throughout the study, up to 43 days for Parts 1B, and up to 78 days for Part 2

Results and safety

Results posted to the registry on 28 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1A: Cohort 1	1	1
Part 1A: Cohort 2	1	1
Part 1A: Cohort 3	1	1
Part 1A: Cohort 4	3	3
Part 1A: Cohort 5	3	3
Part 1A: Cohort 6	6	6
Part 1B: Cohort 1	0	0
Part 1B: Cohort 2	0	0
Part 2	0	0

Primary outcome: Number and Types of Adverse Events (AEs), Including Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 Alone in Part 1A

Time frame: Throughout the study, up to 43 days. Number. Unit: participants with adverse events by type

Measure	Part 1A: Cohort 1 n = 1	Part 1A: Cohort 2 n = 1	Part 1A: Cohort 3 n = 1	Part 1A: Cohort 4 n = 3	Part 1A: Cohort 5 n = 3	Part 1A: Cohort 6 n = 6
Any Adverse Event	1	1	1	3	1	5
Treatment-related Adverse Event	0	1	1	1	0	2
Severe adverse event	0	0	0	0	0	0
Treatment-related severe adverse event	0	0	0	0	0	0
Event leading to MGD020 withdrawal	0	0	0	0	0	0

Primary outcome: Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 1B.

Time frame: Throughout the study, up to 43 days. Number. Unit: participants with AE by type

Measure	Part 1B: Cohort 1 n = 3	Part 1B: Cohort 2 n = 3
Any AE	2	1
Treatment-related AE	2	0
Severe AE	1	0
Severe treatment-related AE	0	0
Event leading to MGD020 withdrawal	0	0
Event leading to MGD014 withdrawal	0	0

Primary outcome: Number and Types of AEs, Including SAEs, and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 and MGD014 in Part 2.

Time frame: Throughout the study, up to 81 days.. Number. Unit: participants with AE by type

Measure	Part 2 n = 3
Any AE	2
Treatment-related AE	0
Severe AE	0
Severe treatment-related AE	0
Event leading to MGD020 withdrawal	0
Event leading to MGD014 withdrawal	0

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: The safety assessment is based on evaluation of AEs occurring from the first administration of study drug(s) through the End of Study Visit or 30 days after the last dose of study drug(s) [up to approximately Day 43 in Part 1A and 1B, and up to approximately 81 days in Part 2] , whichever is later. The safety assessment is based on signs, symptoms, physical examination findings, and laboratory test results.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1A: Cohort 1	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Part 1A: Cohort 2	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Part 1A: Cohort 3	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Part 1A: Cohort 4	0 of 3 (0%)	3 of 3 (100%)	0 of 3
Part 1A: Cohort 5	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Part 1A: Cohort 6	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Part 1B: Cohort 1	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3
Part 1B: Cohort 2	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3
Part 2	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 28 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Human Immunodeficiency Virus I Infection

RecruitingObservational study
Evaluation of Patients With HAM/TSP
HTLV-I Infection, Tropical Spastic Paraparesis
RecruitingPhase 1
A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants
HIV Infections
RecruitingPhase 1/2
Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Allogeneic Hematopoietic Cell Bone Marrow Transplantation Followed by Graft-versus-Host-Disease (GVHD) Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies ...
HIV, Hematologic Malignancies
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis

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.

Pepi Pencheva, MD study director

MacroGenics

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MGD020 and MGD014 in people with Human Immunodeficiency Virus I Infection and Immunodeficiency Virus Type 1, Human, run by MacroGenics at 3 sites 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 10 inclusion and 6 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 28 Mar 2025). 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 and Types of Adverse Events (AEs), Including Serious Adverse Events (SAEs), and AEs Leading to Treatment Discontinuation in Participants Receiving MGD020 Alone in Part 1A (time frame: Throughout the study, up to 43 days). The study lists 3 primary outcomes in all. 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 NCT05261191.

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 28 Mar 2025.