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GSK3810109A for Human Immunodeficiency Virus Infection
Study Summary
This trial is testing a new antiviral drug, GSK3810109A, to see if it is safe and effective in HIV-1 infected adults who have not taken any other HIV treatment before.
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2023 Phase 2 trial • 63 Patients • NCT04871113Trial Design
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Who is running the clinical trial?
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- If the doctor believes that you have a high risk of harming yourself or have had thoughts of wanting to harm yourself in the past, you may not be able to participate in the study.You have received any vaccine for HIV-1 prevention or treatment.You have previously received a licensed or experimental type of medication called a monoclonal antibody.You have a known history of liver disease called cirrhosis, which can be caused by different factors including viral hepatitis.You have not received ARTs (in combination or monotherapy) after the diagnosis of HIV-1 infection.You have a skin condition that could make it hard to evaluate the injection sites, such as infections, rashes, or allergies.
- Group 1: Part 2: Participants receiving GSK3810109A (Cohort 4)
- Group 2: Part 2: Participants receiving GSK3810109A (Cohort 5)
- Group 3: Part 1: Participants receiving GSK3810109A 40 mg/kg (Cohort 1)
- Group 4: Part 1: Participants receiving GSK3810109A 280 mg (Cohort 2)
- Group 5: Part 2: Participants receiving GSK3810109A (Cohort 3)
- 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
Is the eligibility criteria for this study limited to individuals under 35 years of age?
"This research study is accepting patients who are at least 18 years of age and no more than 65 years old."
How many healthcare facilities are partaking in this experiment?
"The trial is currently taking place in 15 different sites, with the most prominent being Birmingham, Long Beach and Indianapolis. To reduce any travelling hassles, we recommend you select a site that's closest to your current residence."
Has GSK3810109A been given regulatory clearance by the FDA?
"Based on our internal analysis, the safety profile GSK3810109A is rated as a 2. This rating reflects its current status in Phase 2 trials where only limited data supports safety but no evidence of efficacy has been documented yet."
Is it feasible for me to join this medical study?
"This medical trial is searching for up to 44 participants living with HIV, aged 18-65. Notably, the criteria spans gender and sexual practices: men and women of childbearing potential must have negative pregnancy tests prior to participating and all individuals should be counselled on safer sexual practices. Additionally, only antiretroviral naïve patients who weigh between 50kg - 115kg are eligible."
Is enrollment open for this clinical experiment at the moment?
"The hosting website, clinicaltrials.gov states that this trial is no longer seeking participants having been first posted on June 22nd 2021 and last updated October 25th 2022. Despite the inactivity of this particular study, there are still 484 other trials attempting to enroll patients at present."
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What portion of applicants met pre-screening criteria?
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