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Nucleoside/nucleotide reverse transcriptase inhibitor

Switch to E/C/FTC/TAF daily for HIV/AIDS (UCLACAREMITO Trial)

Phase 1 & 2
Waitlist Available
Led By Theodoros Kelesidis, MD, PhD, Msc
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month visit after switch
Awards & highlights

Summary

This trial will explore whether the newer nucleoside/nucleotide reverse transcriptase inhibitor tenofovir alafenamide is associated with less mitochondrial toxicity than tenofovir disoproxil fumarate in people living with HIV.

Eligible Conditions
  • HIV/AIDS
  • Antiviral Toxicity
  • Antiviral Drug Reaction
  • Mitochondrial Dysfunction

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month visit after switch
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month visit after switch for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cells
Secondary outcome measures
Change in amount of mitochondrial DNA (mtDNA) over 12 months after switch of antiretrovirals.
Change in mitochondrial function [abnormal mitochondrial dynamics (increase fragmentation of mitochondria)] over 12 months after switch of antiretrovirals.
Change in mitochondrial function [membrane potential (Δψm)] over 12 months after switch of antiretrovirals.
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Switch to E/C/FTC/TAF dailyExperimental Treatment1 Intervention
Intervention: Participants will be asked to switch antiretrovirals (ART) for a period up to 12 months and mitochondrial physiology will be assessed using a variety of assays. The new ART will be If the participant is on an ART other than Elvitegravir (ELV)/cobicistat CO)/emtricitabine (FTC)/tenofovir (TDF)] (E/C/FTC/TDF) then the participant will be asked to switch to E/C/FTC/TDF for up to 6 months. This will allow for future switch (after these 6 months) from E/C/FTC/TDF 1 tablet once daily to E/C/FTC/ tenofovir alafenamide (TAF) 1 tablet once daily for a period of 12 months. If the participant is on E/C/FTC/TDF 1 tablet once daily then the participant will be asked to switch from /C/FTC/TDF 1 tablet once daily to /C/FTC/TAF 1 tablet once daily for a period of 12 months.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Switch to E/C/FTC/TAF daily
2019
Completed Phase 2
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor
1,541 Previous Clinical Trials
10,267,017 Total Patients Enrolled
Gilead SciencesIndustry Sponsor
1,086 Previous Clinical Trials
848,404 Total Patients Enrolled
Theodoros Kelesidis, MD, PhD, MscPrincipal Investigator - University of California, Los Angeles
Resnick Neuropsychiatric Hospital at UCLA, Ronald Reagan UCLA Medical Center
University Athens (Medical School)
St Elizabeth'S Medical Center (Residency)
~4 spots leftby Sep 2025
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