HIV/AIDS
Conditions
Interventions
Sponsors
University of North Carolina Chapel Hill
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. HIV infection 2. Ages = 18 to = 65 years old 3. Able and willing to give written informed consent. 4. Able and willing to stay in contact with site during the duration of the trial 5. Able and willing to provide adequate locator information. 6. Able and willing to comply with all study requirements through duration of the trial. 7. Continuous ART for a minimum of 24 months prior to screening, defined as not missing more than 9 consecutive days in the last 3 months prior to screening. 8. No change in any ART medication in the 30 days prior to screening 9. Able and willing to comply with all study requirements through duration of the trial 10. CD4 cell count = 400 cells/mm3 performed at screening 11.Plasma HIV-1 RNA <50 copies/mL at 2 time points in the 24 months prior to screening and never =50 copies/mL on 2 consecutive time points in the last 24 months 12. No HIV RNA =200 copies/mL in the 6 months prior to screening 13. At US sites, Hepatitis C (HCV) antibody negative result at screening or, if the participant is HCV antibody positive, a negative HCV RNA at screening; at Kenyan sites, participants must be HCV antibody negative at screening 14. Hepatitis B surface antigen (HBsAg) negative at screening 15. Women of child-bearing potential must have a negative serum pregnancy test with a sensitivity of at least 25 mIU/mL at screening 16. For participants with partners who do not have HIV or HIV status unknown, willingness to abstain from sexual intercourse, use a condom, and/or advise partner(s) to use pre-exposure prophylaxis (PrEP) consistently during the study TTI and until plasma HIV-1 RNA is <200 copies/mL if assigned to Arm B. 17. All participants must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) while on study and for 6 months after their last IP intervention.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breastfeeding. 2. Untreated syphilis infection defined as a positive rapid plasma reagin (RPR) without clear documentation of treatment 3. Current treatment for HCV or HCV treatment within 6 months prior to enrollment. 4. Received any infusion blood product or hematopoetic growth factors within 3 months prior to enrollment. 5. Started ART within 90 days of diagnosis with acute HIV-1 infection. 6. Use of antiretrovirals that might interfere with MGD014 or MGD020: maraviroc (Selzentry), enfuvirtide (T-20), fostemsavir (Rubokia), Ibalizumab (Trogarzo) 7. Use of long-acting antiretroviral regimens given potential TTI 8. Use of any of the following agents within 90 days prior to enrollment: immunomodulatory, cytokine, or growth stimulating factors such as systemic cytotoxic chemotherapy or immune globulin, interferons, coumadin, warfarin, or other Coumadin derivative anticoagulants 9. Intent to use immunomodulatory treatment during the study 10. Use of systemic corticosteroids within 30 days prior to enrollment, or anticipated need for periodic use of systemic corticosteroids during the study 11. Use of medications that carry risk of torsade des pointes 12.Receipt of compounds with HDAC inhibitor-like activity, such as valproic acid within the last 30 days. Potential participants may enroll after a 30-day washout period 13. Use of any other investigational treatment within 6 months prior to enrollment, with the exception of Phase 2 or higher studies of antiretroviral agents 14. Any serious illness requiring systemic treatment or hospitalization, the participant must either complete therapy or be clinically stable on therapy, in the opinion of the site investigator, for at least 90 days prior to enrollment 15. Any medical, psychiatric, substance abuse, occupational or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or assessment of safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Occurrence of at least one = Grade 3 AE including signs/symptoms, lab toxicities, and/or clinical events that is probably or definitely related to study treatment from the first day of study treatment through two weeks after completion of study treatment 2. Receipt of the full course of study treatment, defined as receipt of all four MGD014 and MGD020 doses and no more than 4 missed doses of VOR, or a TTI of less than 10 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Serum MGD020 concentrations 2. Serum MGD014 concentrations 3. Incidence of ADA to MGD020 and MGD014 4. Incidence of treatment emergent AEs, SAEs, and AEs leading to discontinuation | — |
Countries
Kenya
Contacts
Public ContactCharles Kilel
Community Liason Kericho CRC
Outcome results
None listed