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

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02134431
Study type	Observational
Source	University of California, Los Angeles
Contact
Status	Completed
Phase	N/A
Start date	May 2014
Completion date	June 2015

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03516318` - Using Social Media to Improve ART Retention and Treatment Outcomes Among YLHIV in Nigeria	N/A
Completed	`NCT04653194` - Efficacy of BIC/F/TAF Versus Standard of Care in the Treatment of New HIV Infection Diagnoses in the Context of 'Test and Treat'	Phase 3
Completed	`NCT01792570` - DRV/r + RPV QD: Efficacy and Toxicity Reduction	Phase 3
Active, not recruiting	`NCT04826562` - Switch to DOVATO in Patients Suppressed on Biktarvy (SOUND)	Phase 4
Completed	`NCT04191967` - Thermocoagulation for Treatment of Precancerous Cervical Lesions	N/A
Completed	`NCT02812329` - Intervention to Encourage HIV Testing and Counseling Among Adolescents	Phase 1
Completed	`NCT02919306` - Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults	Phase 1/Phase 2
Completed	`NCT02651376` - Safety and Efficacy of Allogenic Adoptive Immune Therapy for Advanced AIDS Patients	Phase 1/Phase 2
Completed	`NCT02516930` - A Non-inferiority Randomized Controlled Trial to Evaluate Promoting Condom Use Among MSM and Transgender Individuals in China	N/A
Recruiting	`NCT02392884` - HIV Medication Adherence in Underserved Populations	N/A
Completed	`NCT01944371` - Short-term Disulfiram Administration to Reverse Latent HIV Infection: a Dose Escalation Study	Phase 1/Phase 2
Recruiting	`NCT01778374` - Mater-Bronx Rapid HIV Testing Project.	N/A
Completed	`NCT00914225` - Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya	N/A
Completed	`NCT01490346` - Tissue Drug Levels of HIV Medications	N/A
Completed	`NCT01076179` - Kaletra in Combination With Antiretroviral Agents	N/A
Completed	`NCT01460433` - Problems With Immune Recovery in the Gut Tissue	N/A
Completed	`NCT00317460` - Buprenorphine and Integrated HIV Care	Phase 4
Terminated	`NCT04240210` - Integrase Regimen Switch to Symtuza to Increase Tolerability/Adherence (SYMita)	Phase 4
Active, not recruiting	`NCT04704336` - Integration of Hypertension Management Into HIV Care in Nigeria	N/A
Completed	`NCT03254277` - 3BNC117-LS First-in-Human Phase 1 Study	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms