MGD014 in HIV-Infected Individuals on Suppressive Antiretroviral Therapy

Status Completed

Clinical 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03570918
Study type	Interventional
Source	MacroGenics
Contact
Status	Completed
Phase	Phase 1
Start date	September 25, 2018
Completion date	September 28, 2021

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03940521` - Bioclinical Evaluation of 2 Biomarkers of Aviremic HIV-1 in CD4+ T Cells of Adults Undergoing Treatment
Completed	`NCT03227731` - Immediate or Deferred Pre-exposure Prophylaxis for HIV Prevention: Safe Options for Pregnant and Lactating Women	Phase 2/Phase 3
Not yet recruiting	`NCT06336434` - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy	Phase 1/Phase 2
Active, not recruiting	`NCT04022967` - ANRS 12372 MODERATO Study	Phase 3
Not yet recruiting	`NCT06337032` - A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments	Phase 4
Not yet recruiting	`NCT06282783` - Studying Topiramate for Re-Activating the HIV-1 Reservoir	Phase 1/Phase 2
Completed	`NCT04711265` - Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
Recruiting	`NCT03536234` - Efficacy and Safety of GnRH Analogue Triptorelin for HIV-1 Reservoir Reduction in ART Treated HIV-1 Infected Patients	Phase 2
Completed	`NCT04340388` - Contribution of Dolutegravir to Obesity and Cardiovascular Disease	Phase 4
Withdrawn	`NCT05769569` - Safety and Efficacy of Neutralizing Antibodies and Vaccination for Induction of HIV Remission	Phase 1
Enrolling by invitation	`NCT05584397` - Comparing Immune Activation and Latent HIV Reservoir Size Between People Living With HIV on Tenofovir-containing Versus NRTI-free ART
Completed	`NCT04388904` - Rapid Reinitiation of a Single Tablet Antiretroviral Therapy Using Symtuza® in HIV-1 Infected Treatment-Experienced Patients Off Therapy. (ReSTART)	Phase 4
Not yet recruiting	`NCT04894357` - Impact of V106I on Resistance to Doravirine
Completed	`NCT04963712` - Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder	Early Phase 1
Completed	`NCT04568239` - Impact of M184V on the Virological Efficacy to 3TC/DTG (LAMRES)
Not yet recruiting	`NCT04311944` - Early Fast-Track Versus Standard Care for Persons With HIV Initiating TLD	N/A
Not yet recruiting	`NCT04513496` - Telemedicine in HIV Care in Buenos Aires
Not yet recruiting	`NCT04311957` - Continuation of Protease-Inhibitor Based Second-Line Therapy vs. Switch to B/F/TAF in Virologically Suppressed Adults	Phase 4
Completed	`NCT03998176` - Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF) in HIV-1 Infected Patients With Active Illicit Substance usE	Phase 4
Completed	`NCT04416906` - A Test and Treat Strategy in New HIV Diagnosis.	Phase 3