Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MGD020 · 1 trial · 1 indication
Safety data will include signs/symptoms, lab toxicities, and/or clinical events that are probably or definitely related to study treatment MGD014, MGD020, Temporary Treatment Interruption (TTI) and/or Vorinostat (VOR) through two weeks post completion of study treatment. The DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table), corrected Version 2.1, July 2017 was used to measure safety where Grade 1 is defined as mild, Grade 2 is defined as moderate, Grade 3 is defined as severe, and Grade 4 is defined as potentially life-threatening.
Receipt of the full course of study treatment is defined as receipt of all four MGD014 and MGD020 infusions. In addition for Arm B, the temporary treatment interruption (TTI) must have been longer than 10 days. In addition for Arm C, the participant must have received at least 16 Vorinostat (VOR) doses (Arm C).
| Arm | Type | Description |
|---|---|---|
| Arm A - MGD014/MGD020 Infusions | EXPERIMENTAL | MGD014 and MGD020 infusions at Day 0, Week 2, Week 4 and Week 6. |
| Arm B - MGD014/MGD020 Infusions with Temporary Treatment Interruption (TTI) | EXPERIMENTAL | MGD014 and MGD020 infusions at Day 0, Week 2, Week 4, and Week 6 in combination with a TTI from Day 4 to Week 8. |
| Arm C - MGD014/MGD020 Infusions with Vorinostat | EXPERIMENTAL | MGD014 and MGD020 infusions at Day 0, Week 2, Week 8, and Week 10 in combination with VOR from Day 0 to Week 4 and Week 8 to Week 12. |
| Name | Type | Description |
|---|---|---|
| MGD020 | DRUG | Administered intravenously at 300mg/kg over 60 minutes. |
| MGD014 | DRUG | Administered intravenously at 300mg/kg over 60 minutes. |
| Vorinostat | DRUG | Administered orally at 400 mg every 72 hours. |
| Temporary treatment interruption | OTHER | Discontinuation of antiretroviral therapy (ART) through Week 8. If a participant meets protocol-defined ART restart criteria during the temporary treatment interruption (TTI), ART will be reinitiated immediately. Participants who do not meet restart criteria will remain off ART and continue weekly monitoring until Week 8, at which point ART will be resumed. |
Inclusion Criteria: 1. HIV infection initially documented by at least one of the following at any time prior to study entry: * any licensed rapid HIV test * HIV antibody test * HIV Ag/Ab assay …and documented confirmation by at least one of the following at any time prior to study e...
MGD020 is an investigational small molecule being developed for the treatment of HIV (Human Immunodeficiency Virus). It is currently in Phase 1 clinical development, meaning it has not yet been approved and is still being studied for safety and efficacy in humans.
MGD020 is being developed by United Therapeutics Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker UTHR. The company is conducting a Phase 1 clinical trial of MGD020 in patients with HIV.
MGD020 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The ongoing Phase 1 trial is actively recruiting participants to evaluate the drug's safety, tolerability, and pharmacokinetics in people with HIV.
MGD020 is being studied in a Phase 1 clinical trial with the identifier NCT07217379, titled "The DART DELIVER-02 Study." This randomized, controlled trial is recruiting 24 participants with HIV at sites in the United States and Kenya, and is currently in the recruiting stage.
No, MGD020 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The ongoing study, NCT07217379, is designed to evaluate the drug's safety and early efficacy signals in patients with HIV, but regulatory approval has not been granted.