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NCT03251144 · ClinicalTrials.gov registry record · Phase 1

Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF)

A Phase 1 study of HIV/AIDS and Mitochondrial Alteration, sponsored by University of California, Los Angeles.

Completed
Registry status
Phase 1
Development phase
26
Enrollment target
1
Study location

NCT03251144: Completed Phase 1 study of HIV/AIDS and Mitochondrial Alteration, sponsored by University of California, Los Angeles.

NCT03251144 is a Phase 1 study of HIV/AIDS and Mitochondrial Alteration that has completed, run by University of California, Los Angeles. The registered enrollment target is 26 participants, below the 33,180-participant average among 61 other HIV/AIDS trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03251144, a Phase 1 study of HIV/AIDS and Mitochondrial Alteration, has completed, sponsored by University of California, Los Angeles.

COMPLETED
Registry status
Phase 1
Development phase
26 participants
Enrollment target
1
Study location

Study Summary

Increased comorbidities such as cardiovascular disease (CVD), are emerging problems in HIV infection but the mechanisms are unclear. Understanding how antiretrovirals can minimize morbidity in treated HIV infection is a research priority. Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) are included in all HIV treatment regimens. Tenofovir (TFV) disoproxil fumarate (TDF) has been associated with an increased risk of nephrotoxicity and bone disease compared with other NRTIs. Tenofovir alafenamide (TAF) is an oral prodrug of TFV, but is more stable in plasma as compared with TDF and lower plasma levels of TFV are thought to lead to the favorable safety profile of TAF. Mitochondrial dysfunction has a key role in HIV pathogenesis and may be the common denominator that drives pathogenesis of several comorbidities. Despite the better safety profile of newer (such as TDF) compared to older NRTIs, there are concerns for the potential for longer term toxicity of NRTIs since the exact cellular effects of NRTIs remain unclear. It is unknown whether a four-fold increase in intracellular drug levels seen in peripheral blood mononuclear cells (PBMCs) with TAF may increase toxicity in mitochondria. Better understanding of these effects could provide insights into mechanisms of HIV pathogenesis and selection of NRTIs that improve morbidity in chronic HIV infection. Hypothesis: Despite higher intracellular levels, TAF has minimal mitochondrial toxicity compared to TDF in vivo. This research will explore the relative mitochondrial toxicity of newer NRTIs (TAF, TDF) as a possible mechanism for differential NTRI-related toxicities. These data will allow selection of NRTIs that may improve morbidity in chronic treated HIV infection. Towards this aim, the investigators will use a robust experimental approach to study NRTI-related mitochondrial dysfunction using novel methods, human cell lines and PBMC. Our specific aims are: Aim 1: To evaluate the relative in vitro effects

Primary Outcome

Change in mitochondrial function \[abnormal mitochondrial dynamics \[(cellular oxygen consumption (COC)\] over 12 months after switch of antiretrovirals.

Conditions Studied

HIV/AIDS Mitochondrial Alteration Antiviral Toxicity Antiviral Drug Adverse Reaction

Interventions

  • DRUG Switch to E/C/FTC/TAF daily

Study Locations (1)

California

  • UCLA CARE Center - Los Angeles

Trial Details

FieldValue
Enrollment Target 26 participants
Start Date 2019-04-01
Est. Completion 2021-07-01
Phase Phase 1
University of California, Los Angeles

897 total trials

What the finished NCT03251144 record still lists

NCT03251144 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 33,180-participant average among 61 other HIV/AIDS trials with a reported enrollment target (100% lower).

The record links to 4 conditions, with HIV/AIDS appearing as the primary indexed condition, and to 1 intervention - of which Switch to E/C/FTC/TAF daily is the first listed.

NCT03251144 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT03251144 about?

NCT03251144 is a clinical study titled "Relative Mitochondrial Toxicity of Tenofovir Alafenamide (TAF) vs. Tenofovir Disoproxil Fumarate (TDF)". Increased comorbidities such as cardiovascular disease (CVD), are emerging problems in HIV infection but the mechanisms are unclear. Understanding how antiretrovirals can minimize morbidity in treated HIV infection is a research priority. Nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs...

What is the current status of trial NCT03251144?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2019-04-01. Estimated completion is 2021-07-01.

What conditions does trial NCT03251144 study?

This clinical trial studies the following conditions: HIV/AIDS, Mitochondrial Alteration, Antiviral Toxicity, Antiviral Drug Adverse Reaction.

What interventions are being tested in trial NCT03251144?

The interventions under investigation include: Switch to E/C/FTC/TAF daily (DRUG).

Who is sponsoring clinical trial NCT03251144?

This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03251144 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03251144's enrollment target sits among peer trials

26 55th of 61 higher than 7 of 61 other HIV/AIDS trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV/AIDS trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03251144, the US trial registry maintained by the National Library of Medicine. NCT03251144 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.