Phase 1 N=21 Treatment

MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy

HIV-1-infection

Bottom Line

View on ClinicalTrials.gov: NCT03570918 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2022

Primary outcome: Primary: Number of Participants With Treatment-Emerging Adverse Events — 1; 1; 4; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: MGD014 (Biological)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MacroGenics
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Treatment-Emerging Adverse Events	1; 1; 4; 3; 2; 2	—
SECONDARY AUC Inf: Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity of MGD014	134; 313; 2610; 6360; 22300; 50900	—
SECONDARY Cmax: Maximum Plasma Concentration	2.9; 5.8; 24.5; 67.7; 181; 469	—
SECONDARY Tmax: Time to Maximum Concentration	3.0; 1.9; 2.4; 2.0; 2.7; 1.9	—
SECONDARY Ctrough: Trough Level Concentration	320	—
SECONDARY Clearance	0.04; 0.07; 0.03; 0.05; 0.04; 0.04	—
SECONDARY Vz: Terminal Phase Volume of Distribution of MGD014	2.1; 4.1; 8.7; 19.7; 17.5; 17.4	—
SECONDARY Terminal Half Life of MGD014	32.0; 38.6; 244; 300; 295; 282	—
SECONDARY Number of Participants That Developed Antidrug Antibodies to MGD014	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Participants With Increased Cytokine Levels	0; 0; 1; 0; 0; 0	—

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).

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03570918). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.