PrEP Pod-IVR for HIV Prevention

(PrEP-Pod-IVR Trial)

This trial tests a new method to prevent HIV using a ring that delivers medication inside the body. Researchers aim to assess the effectiveness and acceptability of this treatment by comparing a real medication ring with a placebo (an inactive version). The real medication ring contains Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine (FTC), drugs used for HIV prevention. The study involves female participants who are HIV-negative, in good health, and willing to use the ring and follow study guidelines. Participants will also share their experiences through surveys and interviews. This trial suits women committed to using study-provided protection and abstaining from certain activities as required. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking HIV prevention efforts.

Yes, you may need to stop taking certain medications. The trial requires participants to abstain from using specific medications, such as blood thinners like Warfarin and certain NSAIDs (like ibuprofen) before biopsies, as well as rectally or vaginally administered medications during the study.

Research shows that the combination of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine (FTC) is generally safe for preventing HIV. Studies have found that most people tolerate this combination well.

For those considering joining a clinical trial, it's important to know that the FDA has already approved TDF/FTC for HIV prevention. This approval means it has been tested in many people and shown to be safe. Most side effects are mild, such as headaches or an upset stomach.

Researchers are excited about the PrEP Pod-IVR treatment for HIV prevention because it offers a novel delivery method that sets it apart from traditional oral medications like Truvada. Unlike daily pills, this investigational treatment uses a pod-intravaginal ring (pod-IVR) to deliver the active ingredients, Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine (FTC), directly at the site where the virus might enter the body. This local delivery method may improve adherence and reduce systemic side effects, making it a promising alternative for those who struggle with daily pill regimens. By potentially offering more consistent protection with less frequent dosing, this new approach could significantly enhance HIV prevention strategies.

Research shows that taking Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine (FTC) as pre-exposure prophylaxis (PrEP) can significantly lower the risk of contracting HIV. Studies have found that maintaining certain levels of these drugs in the blood can reduce HIV risk by up to 90%. In another study, daily use of TDF/FTC reduced the chance of contracting HIV by 44% among men who have sex with men and transgender women. This treatment works by preventing the virus from multiplying in the body. While PrEP is effective, it is not 100% guaranteed and does not protect against HIV strains resistant to these drugs. Participants in this trial will receive either the TDF-FTC pod-IVR or a placebo pod-IVR, with the sequence of treatments varying between the two study arms.⁶⁷⁸⁹¹⁰