Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MacroGenics
With
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)
Department of Health and Human Services
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
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
Clareo Health | A Study of MGD020 Alone or Combined With MGD014 in Persons With HIV-1 on Antiretroviral Therapy
