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Dolutegravir + Tenofovir Alefenamide Metabolic Effects in Healthy Volunteers
Study Summary
This trial studies how a common HIV drug affects how the body uses energy. Healthy adults aged 18-55 can take part. Tests include measuring oxygen intake, X-rays, and laser scans.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have had weight loss surgery in the past.I do not have an infection with HIV or hepatitis A, B, or C.My BMI is either below 18.5 or above 30.I have diabetes.I have asthma or COPD.I have or have had glaucoma.I am currently using prescription medications, including Descovy or Truvada in the last 6 months.I have liver disease or my liver enzyme levels are high.I am willing to stay in the hospital for two 11-day periods over 5 weeks.I have never been exposed to cabotegravir.I am not taking over-the-counter meds that could affect the study drugs.I haven't had cancer in the last 5 years, except for treatable skin cancer.I am currently using products that change how my body uses energy.I have kidney problems or my kidneys don’t filter waste well.I have a history of heart problems or an abnormal heart test result.I do not have psychological conditions like claustrophobia or depression that would prevent me from safely participating.I am between 18 and 55 years old.My thyroid function is normal or any abnormalities are not significant.My blood pressure is over 140/90 mm Hg or I am on medication for high blood pressure.
- Group 1: Tenofovir alafenamide
- Group 2: Dolutegravir
- 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 participation in this medical study open to octogenarians and beyond?
"Aged between 18 and 55? This clinical trial is the one for you. There are 74 studies suitable for minors, while 206 of them focus on older adults."
Are there still opportunities for participation in this experiment?
"According to the clinicaltrials.gov portal, this specific medical investigation is no longer searching for individuals at this moment in time. The trial was initially uploaded on December 20th 2022 and has not been modified since then. Luckily, there are 303 other trials seeking volunteers currently available."
Are there any potential dangers associated with Tenofovir alafenamide treatments?
"With Phase 2 clinical trials providing evidence of safety, Tenofovir alafenamide is estimated to have a score of 2 in terms of its risk-factor. Unfortunately, no data has been collected with regards to efficacy yet."
Who is qualified to participate in this research study?
"This medical trial needs to enlist 120 age-eligible patients with weight gain. To be considered, participants must agree to the following: being between 18 and 55 years old, providing informed consent, remaining in the calorimetry suite on 6 occasions, living at a clinical centre for two 10 day stretches over 5 weeks time period, and allowing samples and data be used for future research."
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What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
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