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Integrase Strand Transfer Inhibitor
Dolutegravir + Tenofovir Alefenamide Metabolic Effects in Healthy Volunteers
Phase 2
Recruiting
Led By Janaki C Kuruppu, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
Healthy individuals aged 18 to 55 who can consent and stay in a clinic for two periods of 11 days. They shouldn't have asthma, COPD, HIV, hepatitis A/B/C, extreme weight changes recently or be athletes. No cancer (except certain skin cancers), diabetes, thyroid issues, glaucoma, psychological conditions like claustrophobia or depression that affect participation safety. Not for pregnant/post-partum women or those with high blood pressure, anemia, drug/alcohol abuse history within five years.
What is being tested?
The trial is testing how the HIV medication dolutegravir affects body energy use compared to tenofovir alafenamide. Participants will take one drug for eight days during each clinic stay and undergo tests including room calorimetry measuring oxygen intake and carbon dioxide output six times; DEXA scans for body fat and bone density; plus other assessments of body composition.
What are the potential side effects?
Potential side effects are not detailed but may include reactions related to metabolic changes due to the medications being tested. Since these drugs are generally used in treating HIV/AIDS patients rather than healthy volunteers as in this study context, specific side effects experienced by participants could differ from typical patient profiles.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 10 and 38
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 10 and 38
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in 24-hour energy expenditure and 24-hour RQ from baseline to day 1 and day 8 of ARV therapy with each drug
Secondary study objectives
Relationship between demographic data or baseline laboratory values and changes in energy expenditure or caloric intake
Relationship between pharmacokinetic parameters for TAF and DTG and changes in energy expenditure or caloric intake.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Tenofovir alafenamideActive Control1 Intervention
25mg one tablet orally once a day for 8 days.
Group II: DolutegravirActive Control1 Intervention
50mg one tablet orally once daily for 8 days.
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Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,323 Previous Clinical Trials
5,364,648 Total Patients Enrolled
4 Trials studying Obesity
1,511 Patients Enrolled for Obesity
Janaki C Kuruppu, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
1 Previous Clinical Trials
127 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Tenofovir alafenamide
- Group 2: Dolutegravir
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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