Integrase inhibitor versus protease inhibitor based regimen for HIV-1 infected women (WAVES): a randomised, controlled, double-blind, phase 3 study.
Kathleen Squires, Cissy Kityo, Sally Hodder...
https://pubmed.ncbi.nlm.nih.gov/27562742Actively Recruiting
Phase 2
Age: 18Years - 55Years
All Genders
Healthy Volunteers
ID05652478
Early Metabolic Effects of Antiretroviral Drugs in Healthy Volunteers: A Phase 2 Randomized Study
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-06-08
120
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how certain antiretroviral drugs called integrase strand transfer inhibitors (INSTIs), used to treat HIV, may cause weight gain and affect metabolism in healthy people. This Phase 2 randomized trial aims to understand changes in plasma metabolites and other biological markers after 4 weeks of treatment with these drugs without the influence of HIV infection. The study also explores how these medications may alter gene expression and the body's metabolic pathways. Participants will be randomly assigned to one of four groups receiving different oral treatments for 4 weeks: Dolutegravir (DTG), Tenofovir alafenamide (TAF), a combination of DTG and TAF, or Tenofovir Disoproxil Fumarate (TDF). Before starting treatment, participants undergo a lead-in baseline visit with exams and blood tests. During the 4-week treatment, participants take their assigned drug once daily. The study includes optional fat tissue biopsies and microbiome sample collections. Participants will visit the clinic multiple times for exams, lab tests, and monitoring. Evaluations include physical exams, nutritional assessments, heart function tests, dual-energy X-ray absorptiometry (DEXA) scans to measure body fat and bone density, and continuous glucose monitoring. Samples from blood, fat tissue, and microbiome sites will be collected before and after treatment to analyze changes. The study tracks metabolic, genetic, and proteomic changes over approximately 6 weeks from baseline through the end of treatment and follow-up.
CONDITIONS
Brief Title
Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study
Who Can Participate
Age: 18Years - 55Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Aged 18 to 55 years.
- Able to provide informed consent.
- Willing to allow samples and data to be stored and shared for future research.
- Agrees to use a barrier method of contraception or abstain from sexual activity from screening through the end of study participation.
You will not qualify if you...
- Current infection with HIV or hepatitis A, B, or C.
- Body mass index (BMI) less than 18.5 or greater than 30.0 kg/m².
- Weight change greater than 5% in the past 6 months.
- History or current cardiovascular disease, including congestive heart failure or abnormal ECG.
- History or current liver disease or elevated liver enzymes above twice the normal limit.
- History or current kidney disease or low estimated creatinine clearance (≤80 mL/min).
- Current cancer or cancer history within 5 years, excluding localized skin cancers.
- History of bariatric surgery.
- Diabetes diagnosis or hemoglobin A1c greater than 6.4%.
- Fasting serum glucose above 126 mg/dL.
- History or current thyroid disorders except minor non-significant deviations.
- History or current asthma or chronic obstructive pulmonary disease.
- Psychological conditions such as clinical depression or bipolar disorder incompatible with study participation.
- Pregnancy or within 1 year after childbirth.
- Breastfeeding.
- High blood pressure above 140/90 mm Hg or current blood pressure medication use.
- Hemoglobin outside 10% below or above normal laboratory ranges.
- History of drug, opioid, or alcohol abuse within 5 years or current excessive use.
- Current use of specific medications or supplements that may interfere with study drugs.
- Use of HIV PrEP drugs TAF, TDF, or FTC in past 6 months.
- Exposure to cabotegravir or lenacapavir.
- Allergic reactions to study drugs.
- Daily caffeine intake exceeding 500 mg.
- Current smoking or tobacco use.
- Recent or planned changes in diet or exercise that could affect study results.
- High-risk sexual activity or inability to use barrier contraception.
- Any other condition or factor that increases risk, prevents compliance, or confounds study results.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 2 weeks
Participants undergo a 2-week treatment-free lead-in period before starting the study drugs.
Visits as needed during lead-in
Treatment
Duration - 4 weeks
Participants take assigned study drug(s) daily for 4 weeks while undergoing assessments including multi-omic sample collections such as adipose tissue biopsy and microbiome sampling before and after treatment.
Daily medication with multiple sample collection visits before and after treatment
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
M
Mary E McLaughlin, R.N.
B
Brian P Epling, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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Jean-Michel Molina, Bonaventura Clotet, Jan van Lunzen...
https://pubmed.ncbi.nlm.nih.gov/26424673Efficacy and tolerability of 3 nonnucleoside reverse transcriptase inhibitor-sparing antiretroviral regimens for treatment-naive volunteers infected with HIV-1: a randomized, controlled equivalence trial.
Jeffrey L Lennox, Raphael J Landovitz, Heather J Ribaudo...
https://pubmed.ncbi.nlm.nih.gov/25285539