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Relationship of Tenofovir With HIV-1 Suppression in ex Vivo Tissue in Adolescents
NCT02134431 · View on ClinicalTrials.gov ↗
Study Summary
Microbicides are topical medicines that can prevent infection by Human Immunodeficiency Virus (HIV). Microbicide medicine has yet to be studied in adolescents, a key group that is becoming infected with HIV all over the world. From past research, we know that at different ages people experience age-related changes in their bodies that can cause differences in how they process medications. In this study, gut tissue samples (or gut biopsies) from 12 HIV-negative volunteers will be collected. These pieces of tissue will be infected with HIV in the laboratory to develop a model that can be used to test certain drugs against the HIV infection. We can use this tissue to test a drug called tenofovir against HIV infection. We will determine whether this drug can decrease HIV infection in the gut biopsies. In this study, we will also measure HIV levels and the levels of tenofovir in gut and blood samples in 12 people who are already taking this drug. This information can determine whether levels of drug found in the gut can protect it from HIV. The results can be compared to other age groups of adolescents and adults. Subjects will undergo a common procedure called a lower endoscopy (this can be a colonoscopy or a flexible sigmoidoscopy) to obtain gut biopsy samples. The central hypothesis is that tissue drug profiles of tenofovir (TFV) and its active component, tenofovir disoproxil fumarate (TDF), and tissue infectibility vary between younger (10-14 years old) versus older adolescents (18-21 years old), and that both differ from adults (\>21 years). Specifically, younger HIV positive adolescents will have lower levels of tissue tenofovir compared to older HIV positive adolescents and adults in an age-dependent manner. Additionally, biopsies from younger HIV negative adolescents will have: 1) higher rates of infection compared to biopsies from older HIV negative adolescents infected with a lower dose of virus; and 2) lower percent suppression of tissue infectivity compared
Conditions Studied
Interventions
- DEVICE flexible sigmoidoscopy or colonoscopy with biopsies
Study Locations (1)
California
- UCLA Clinical and Translational Research Center (CTRC) — Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02134431
The ClinicalTrials.gov registry entry for NCT02134431 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 829 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Human Immunodeficiency Virus appearing as the primary indexed condition, and to 1 intervention — of which flexible sigmoidoscopy or colonoscopy with biopsies is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02134431 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02134431 about?
NCT02134431 is a clinical study titled "Relationship of Tenofovir With HIV-1 Suppression in ex Vivo Tissue in Adolescents". Microbicides are topical medicines that can prevent infection by Human Immunodeficiency Virus (HIV). Microbicide medicine has yet to be studied in adolescents, a key group that is becoming infected with HIV all over the world. From past research, we know that at different ages people experience age-...
What is the current status of trial NCT02134431?
This trial is currently completed. The enrollment target is 13 participants. The study started on 2014-05. Estimated completion is 2015-06.
What conditions does trial NCT02134431 study?
This clinical trial studies the following conditions: Human Immunodeficiency Virus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02134431?
The interventions under investigation include: flexible sigmoidoscopy or colonoscopy with biopsies (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02134431?
This trial is sponsored by University of California, Los Angeles, which has 829 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02134431 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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