Status:
COMPLETED
A Study of MGD020 Alone or Combined With MGD014 in Persons With HIV-1 on Antiretroviral Therapy
Lead Sponsor:
MacroGenics
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Conditions:
Human Immunodeficiency Virus I Infection
Immunodeficiency Virus Type 1, Human
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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 the...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05261191
Start Date
September 26 2022
End Date
May 29 2024
Last Update
March 28 2025
Active Locations (3)
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1
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
2
UNC Hospital - Chapel Hill
Chapel Hill, North Carolina, United States, 27599
3
Case Western Reserve University Hospital
Cleveland, Ohio, United States, 44106