NCT02134431

Relationship of Tenofovir With HIV-1 Suppression in ex Vivo Tissue in Adolescents

Dose-response Relationship of Tenofovir With HIV-1 Suppression in ex Vivo Model of Tissue Infectibility in Adolescents

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 13 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 10 Years – 21 Years
• Healthy volunteers: Accepted

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 to biopsies from older HIV negative adolescents using low dose tenofovir.

Conditions

• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DEVICE	flexible sigmoidoscopy or colonoscopy with biopsies	Lower endoscopy with biopsies (specifically either colonoscopy or flexible sigmoidoscopy) in both HIV-positive subjects already on oral tenofovir , as well as HIV negative subjects. Biopsies will be taken to laboratory for quantification of HIV-1 and drug levels of tenofovir.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-05-09
• Last updated: 2017-03-13

Locations

1 site across 1 country: United States