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DOR/3TC/TDF for Weight Management in HIV (DeLiTE Trial)
DeLiTE Trial Summary
This trial is designed to determine whether switching patients who are gaining weight on an integrase inhibitor-based regimen to a different regimen for one year can help to slow down or even reverse the weight gain.
DeLiTE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowDeLiTE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.DeLiTE Trial Design
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Who is running the clinical trial?
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- I am not taking any medications that interact with doravirine.I have gained more than 10% of my body weight since starting my INSTI-based treatment.I am not taking any medication known to harm the kidneys.My kidney function is reduced with a creatinine clearance under 50 mL/min.My HIV treatment is not working due to resistance to specific medications.I have had kidney problems from TDF medication.You are pregnant or planning to become pregnant within the next year.I started taking medication that can cause weight gain in the last 6 months.I am using effective birth control during the study.I have been on an INSTI-based treatment for 1-5 years.
- Group 1: DOR/3TC/TDF
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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 is the sample size for this clinical research endeavor?
"Currently, this clinical trial is not enrolling patients. It was first posted on April 26th 2021 and last modified on May 17th 2022. If you are looking for alternative studies, there are 258 trials actively recruiting participants with weight gain issues and 93 trials with DOR/3TC/TDF available to join."
Is the combination of DOR/3TC/TDF an accepted pharmaceutical protocol?
"There is a substantial body of evidence that confirms the safety and efficacy of DOR/3TC/TDF, hence it was rated 3 on our 1-to-3 scale."
How is the drug combination of DOR/3TC/TDF traditionally used?
"DOR/3TC/TDF is routinely used for conditions where there are no doravirine resistance-associated mutations present. It can also help patients suffering from HIV, treatment failure or high risk cases."
To what extent have previous explorations explored the efficacy of DOR/3TC/TDF?
"Presently, there are 93 active clinical trials for DOR/3TC/TDF with 35 of those in Phase 3. The epicenter is Boylston, Massachusetts; yet across the country 1480 sites are running experiments involving this medical intervention."
What specific goals is this clinical trial attempting to fulfill?
"The primary aim of this evaluation, which will span the course of a year, is to detect factors related to premature trial cessation. Secondary objectives include assessing relative weight alteration per annum compared with baseline data; absolute body mass at 48 weeks in comparison to baseline values sans outside clothing, purses and accessories; and ascertaining the proportion of participants who sustain viral suppression (HIV RNA < 50 copies/ml) after transitioning from INSTI-containing medication regimens to DOR/TDF/3TC."
Is the recruitment process for this clinical trial still ongoing?
"This particular medical trial is no longer taking new patients. It was initially posted on April 26th 2021, and its most recent updates were made on May 17th 2022. If you're looking for alternative studies, there are currently 258 trials recruiting participants with weight gain issues and 93 more for DOR/3TC/TDF treatments that still need volunteers."
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