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Semaglutide for Human Immunodeficiency Virus Infection
Study Summary
This trial will test whether semaglutide can help people with HIV who also have fatty liver disease, by reducing the amount of fat in their liver and improving insulin resistance.
- Human Immunodeficiency Virus Infection
- Non-alcoholic Fatty Liver Disease
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 104 Patients • NCT04189848Trial Design
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- If you were assigned male at birth, your waist circumference must be at least 95 cm. If you were assigned female at birth, your waist circumference must be at least 94 cm.You are allowed to switch to a different form of medication that combines multiple drugs into one pill or tablet.You are breastfeeding or planning to become pregnant.You cannot switch your HIV medication during the study.You cannot have taken certain hormones or steroids within the past 3 months before entering the study.You are willing and able to use an auto-inject pen once a week for 24 weeks.A kit approved by the US FDA or a similar regulatory body is required for this study. If the study is conducted outside of the United States, a kit approved by a regulatory body in that country is necessary. It is recommended that non-US studies use US FDA-approved kits.You have been drinking too much alcohol regularly for at least 3 months before the screening.You plan on taking medications that may cause significant changes in your weight during the study.You have taken any medication or treatment that affects your immune system in the last three months before starting the study.You are allergic or sensitive to any ingredients in the study drug.You cannot store the study product at the required temperature.The site investigator thinks you are not suitable to participate in the study due to your medical condition.You must be willing and able to have MRI scans.You have been taking the same amount of Vitamin E for at least a year before starting the study.You have a severe condition that slows down your digestion process.You plan to make big changes to your diet or exercise routine during the study.You have received a liver transplant in the past.If you test positive for HIV on a first test, you will need to take a second test using a different method to confirm the result. This is to make sure that the first test was accurate.You have not changed your HIV medication in the past 24 weeks.You cannot substitute one medication for another within the same class.
- Group 1: Semaglutide
- 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
What adverse effects have been linked to Semaglutide's use?
"Considering the nature of this phase 2 trial - which entails some evidence backing its safety but no proof for efficacy, our team at Power has assigned Semaglutide a score of 2."
Are there multiple venues executing this experiment in the city?
"8 different clinical sites are conducting this research, with the University of Colorado Hospital CRS (Site ID: 6101) in Aurora, University of Washington AIDS CRS (Site ID: 1401) in Seattle, and Houston AIDS Research Team CRS (Site ID: 31473) being particularly noteworthy. The full list also includes 8 additional locations."
How many participants are taking part in the research project?
"Unfortunately, this specific clinical trial is not presently recruiting. It was originally posted on October 1st 2020 and the last edit occurred on October 6th 2022. However, if you're seeking other studies there are 1519 trials for HIV-positive individuals as well as 58 separate investigations related to Semaglutide that are actively enrolling participants."
Has Semaglutide been examined in past experiments?
"Semaglutide was initially investigated in 2018 by Novo Nordisk Investigational Site. As of now, 124 studies have been finalized and 58 are ongoing, with a notable presence in Aurora, Colorado."
In what situations is Semaglutide typically prescribed?
"Primarily, semaglutide is used to help patients manage weight-related issues. In addition, it can be effective in treating coexisting conditions when accompanied by a reduced caloric diet and exercise."
Does this clinical trial represent a pioneering effort?
"Novo Nordisk A/S first studied Semaglutide in 2018, involving 1387 participants. By the end of that trial, it had been approved for Phase 4 drug use and has since spawned 58 concurrent studies spanning 55 nations and 772 cities."
Is the recruitment of participants still ongoing for this clinical trial?
"Unfortunately, this clinical trial has ceased its recruitment of participants. Initially posted on October 1st 2020 and most recently updated on the 6th of October 2022, it is no longer accepting additional patients. However, there are numerous other studies ongoing which may be suitable alternatives; 1519 trials recruiting those with HIV infections and 58 programs focusing on Semaglutide have open enrollment opportunities."
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