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Study Summary
This trial is studying MGD020 as a possible treatment for HIV-1. MGD020 is a molecule that binds to CD3 and gp41 subunit of HIV-1 envelope. This study will test the safety, tolerability, and how well MGD020 works in people with HIV-1 on antiretroviral therapy. The study has 3 parts. Part 1 will test different doses of MGD020 given as a single dose. Part 2 will test MGD020 in combination with MGD014, given as a single dose. Part 3 will test MGD020 and MGD014 given as 3 doses over 4 weeks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I haven't had any HIV-1 vaccines or treatments in the last 6 months, except MGD014 or MGD020.I haven't needed IV treatment for an infection in the last 7 days.I have HIV and my previous treatment with specific HIV medications was not successful.I am between 18 and 70 years old and can give my consent.I have been on HIV medication for at least 2 years and will continue it during the study.I currently have COVID-19.My blood tests for bone marrow, kidney, and liver are within normal ranges.You are not 50 or more copies/mL on 2 consecutive time points within 24 months nor > 1000 copies/mL at any time within 6 months prior to screening.
- Group 1: Part 1A: Dose level 2
- Group 2: Part 2: MGD020 and MGD014
- Group 3: Part 1B: MTD/MAD -1 MGD020 and MGD014
- Group 4: Part 1A: Dose level 3
- Group 5: Part 1A: Dose level 1
- Group 6: Part 1A: Dose level 5
- Group 7: Part 1A: Dose level 6
- Group 8: Part 1A: Dose level 4
- Group 9: Part 1B: MTD/MAD MGD020 and MGD014
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many volunteers are currently participating in this clinical trial?
"Indeed, the information on clinicaltrials.gov displays that this medical trial is currently recruiting for participants. The experiment was initially posted on September 26th 2022 and last modified on October 6th 2022. It requires 54 patients from one specific site to take part in the study."
Are individuals still being invited to participate in this clinical investigation?
"Affirmative. The information hosted on clinicaltrials.gov affirms that this medical trial is actively courting participants, with an initial posting date of September 26th 2022 and most recent amendments published to the study occurring October 6th 2022. 54 people are needed across 1 location for full enrolment."
Is the age restriction for this research study limited to 35 years and below?
"Those wishing to participate in this study must be between 18 and 70 years old. There are 169 trials for minors, while those over 65 have access to 454 different studies."
Am I qualified to join this research project?
"Eligibility for this research requires patients to have HIV-1 and fall within the accepted age range of 18 - 70. A total of 54 participants are being sought out."
Does MGD020 present any risks to those who use it therapeutically?
"Due to the preliminary nature of this trial, MGD020 was given a rating of 1 for safety. This being classified as Phase 1 indicates that there is minimal data available supporting its efficacy and security levels."
Who else is applying?
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