US launches NIH-funded trial of rectal microbicide to prevent HIV

US launches NIH-funded trial of rectal microbicide to prevent HIV

October 31, 2024

Media Advisory

Thursday October 31, 2024

The study will evaluate the safety and acceptability of rectal douching as pre-exposure treatment.

HIV-infected H9T cell

Scanning electron micrograph (yellow) of an infected human H9T cell (blue/green). NIAID

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The National Institutes of Health has begun a clinical trial to test the acceptability and safety of tenofovir, an antiretroviral drug used in a new rectal microbicide for HIV. The "on-demand" method of HIV prevention involves using microbicides before sex that could expose you to HIV.

In the United States, as well as around the world, there are several forms of HIV pre-exposure prophylaxis. These include daily pills, long-acting injections, and monthly vaginal rings. The Centers for Disease Control and Prevention recommends that men, gay or bisexual men, and other people who have sex can use PrEP if they meet specific criteria. “On-demand” oral PrEP There is insufficient evidence to support its use in other populations. The use of rectal microbicides as an “on-demand” HIV prevention tool is being studied to increase the options available to people with HIV who have receptive and anal sex.

Approximately 150 men and women assigned male at birth will be enrolled in the clinical trial. They must have regularly used a non-medicated rectal wash prior to anal receptivity. During a two-month trial, participants will receive an “on-demand” microbicidal rectal douche containing tenofovir and oral PrEP containing tenofovir disoproxil fumarate and emtricitabine. Safety will be closely monitored for all participants. This study will also assess participants’ experiences using their PrEP methods, such as acceptability, compliance, and preference. This study will be conducted at eight sites in the United States.

You can also contact us by clicking here. HIV prevalence slowly declining in the United StatesThe study, which is mid-stage, was funded by the NIH's National Institute of Allergy and Infectious Diseases (NIAID). It also involved the HIV Prevention Trials Network, an NIH-funded HIV prevention trials network. This mid-stage research is funded by the NIH's National Institute of Allergy and Infectious Diseases and conducted by the NIH's HIV Prevention Trials Network. NIH is committed to creating safe and effective HIV prevention technologies that people want, need, and can use.

ClinicalTrials.gov has more information about this study (also known as HPTN 106) under the identifier NCT06560684.

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Sheryl Zwerski DNP is the director of the AIDS Prevention Sciences Program at NIAID. She can be contacted to discuss this study.

NIAID supports and conducts research at NIH, in the United States, and around the world to study and develop new methods for diagnosing, preventing, and treating infectious and immune-mediated diseases. On the NIAID website, you can find news releases, fact sheets, and other NIAID materials. NIAID website.

The National Institutes of Health: The NIH is the medical research agency of the United States Department of Health and Human Services. It includes 27 institutes and centers. The NIH, the nation's medical research agency, is the primary federal agency that conducts and supports basic, translational, clinical, and other types of medical research. It also studies the causes, treatment, and cures of common and rare diseases. Visit the NIH for more information about its programs and services. www.nih.gov.

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