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Doravirine for HIV-Associated Weight Gain
Study Summary
This trial will assess whether people with HIV who have experienced significant weight gain after starting treatment with an integrase strand transfer inhibitor (INSTI) plus tenofovir alafenamide/emtricitabine (TAF/FTC) or TAF/3TC (lamivudine) can either slow their rate of weight gain or lose weight within about 1 year if they switch to a regimen containing doravirine (DOR; a newer, non-nucleoside reverse transcriptase inhibitor medication).
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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- My HIV-1 levels have been undetectable for at least the past year.It's okay if you missed taking your medication a few times in the past year, as long as the gaps were not more than a week long and you had no more than three of them.I started TAF/FTC or TAF/3TC at least 48 weeks before joining the study.The term "licensed" means that the kit used in the study has been approved by a government agency or certified by a reputable organization in the country where the study is taking place.I have confirmed HIV-1 infection.I can get the required HIV medications for the study's duration.If you test positive for HIV on the first test, you need to take a second test using a different method to confirm the result. This is required by the World Health Organization and the Centers for Disease Control and Prevention.I've been on a specific HIV treatment regimen for at least 48 weeks.My tests show major mutations linked to NNRTI resistance.I switched my HIV medication within the same class more than 24 weeks ago.I have taken nevirapine once to prevent passing HIV to my child.I have a confirmed HIV-1 diagnosis.I plan to start or stop taking medication for mental health, thyroid, or diabetes that affects weight.I plan to have weight loss surgery or make major diet or exercise changes soon.I have been diagnosed with osteoporosis or osteopenia.You currently use drugs or alcohol regularly, or have recently stopped using methamphetamine within the past 60 days. This may prevent you from following the study guidelines.I gained over 10% of my weight without a clear reason after starting or changing to INSTI-based ART.I am not planning to start or change any medications that could significantly affect my weight during the study.I have experienced severe kidney side effects from TDF.I haven't been hospitalized or needed serious treatment in the last 30 days.You have a body mass index (BMI) of 27.5 or higher.My HIV has specific mutations (K65R/E/N or M184V/I).I've been on a specific HIV treatment regimen for at least 48 weeks.The ability and willingness of the participant or their legal guardian/representative to provide informed consent is required.I can get the required HIV medications for the study's duration.I have been on a stable hormone dose for more than 12 weeks.
- Group 1: DOR 100 mg + TAF/FTC (or TAF/3TC, depending on location)
- Group 2: DOR 100 mg + TDF/FTC (or TDF/3TC, depending on location)
- Group 3: Continuation of entry INSTI+TAF/FTC (or TAF/3TC)
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Are recruitment efforts currently underway for this medical exploration?
"This medical trial is currently in the recruitment process and has been since May 20th 2021, with its last update occurring on February 22nd 2022."
What is the upper limit for participants in this experiment?
"In order to run this clinical trial, 222 eligible individuals are required. People can join the study at Houston AIDS Research Team CRS (31473) in Texas or Harbor-UCLA CRS (603) in California."
Are there documented accounts of further research into Integrase strand transfer inhibitors?
"Presently, there are 139 clinical trials taking place for Integrase strand transfer inhibitors with 40 of them in the late stages. While Boylston, Massachusetts is a major hub for this research, other 1959 sites across the country are also running studies on Integrase strand transfer inhibitors."
What medical condition typically warrants treatment with Integrase strand transfer inhibitors?
"Integrase strand transfer inhibitors are frequently prescribed to treat HIV infections, however they can also prove effective in preventing transmission and suppressing viral loads when used with patients who have not developed doravirine resistance-associated mutations."
In what number of places is this trial currently being conducted?
"This research project is being conducted at 23 clinical trial sites, with Houston AIDS Research Team CRS (31473) in Houston, Texas; Harbor-UCLA CRS (603) in Torrance, California; and Case CRS (2501) Cleveland, Ohio amongst them."
What potential risks do Integrase strand transfer inhibitors pose to individuals?
"There is a wealth of evidence confirming integrase strand transfer inhibitors' safety, thus garnering it a score of 3."
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