Cabotegravir for HIV Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of a new HIV prevention medication, long-acting Cabotegravir (CAB-LA), for cisgender women (those whose gender identity matches their sex assigned at birth). The research examines real-world outcomes for women using this injectable medication, designed as a long-term alternative to daily oral pills. Cisgender, HIV-negative, non-pregnant women already using CAB-LA may be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking HIV prevention method.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What is the safety track record for Cabotegravir?
Research has shown that Cabotegravir, also known as APRETUDE, has been tested in over 3,500 people worldwide. These studies found that most participants tolerated it well and did not discontinue use due to side effects. The most common side effects included injection site reactions, diarrhea, headaches, fever, fatigue, and insomnia. For most individuals, these side effects were not serious, suggesting that Cabotegravir is safe for many users. However, considering personal health and consulting a doctor before starting any new treatment is important.12345
Why are researchers excited about this trial?
Long-acting cabotegravir for PrEP is unique because it offers a new way to prevent HIV with a less frequent dosing schedule. Traditional PrEP treatments, like daily oral pills, require consistent daily adherence, which can be challenging for some people. Cabotegravir, on the other hand, is administered as an injection every two months, making it a convenient alternative that could improve adherence. Researchers are excited about this treatment because it simplifies the prevention process, potentially increasing its effectiveness and accessibility for cisgender women at risk for HIV.
What evidence suggests that Cabotegravir might be an effective treatment for HIV prevention?
Research has shown that cabotegravir, a long-lasting injection, is highly effective at preventing HIV. Studies found it to be over 99% effective in real-life situations. Compared to the usual daily PrEP pills, individuals using cabotegravir experienced about one-third as many HIV infections, indicating that cabotegravir is 66% more effective than commonly used oral PrEP medications. This trial will focus on cabotegravir's effectiveness in cisgender females, offering a promising option for those who prefer not to take daily pills.678910
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive long-acting Cabotegravir (CAB-LA) for HIV prevention
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cabotegravir
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Midway Specialty Care Center
Lead Sponsor
Citations
Safety and efficacy of long-acting injectable cabotegravir as ...
Outcomes included HIV infection, adverse events, drug resistance, pregnancy-related adverse events, and sexual behavior. We calculated pooled effect estimates ...
2.
viivhealthcare.com
viivhealthcare.com/hiv-news-and-media/news/press-releases/2024/october/real-world-studies-for-apretude/ViiV Healthcare shows more than 99% effectiveness in real ...
ViiV HEALTHCARE SHOWS MORE THAN 99% EFFECTIVENESS IN REAL-WORLD STUDIES FOR APRETUDE (CABOTEGRAVIR LONG-ACTING), THE ONLY APPROVED LONG-ACTING ...
Efficacy and safety of long-acting cabotegravir compared ...
Long-acting injectable cabotegravir PrEP retained high efficacy for HIV prevention in men and transgender women who have sex with men during ...
Clinical Outcomes and Perspectives of People With Human ...
Participants receiving long-acting cabotegravir plus rilpivirine experienced high rates of virologic suppression and a low rate of ...
5.
aidsmap.com
aidsmap.com/news/feb-2022/injected-prep-cabotegravir-maintains-its-advantage-over-four-yearsInjected PrEP: cabotegravir maintains its advantage over ...
People taking the injections had only a third as many HIV infections as people taking the pills: an overall efficacy over TDF/FTC of 66%, ...
Safety Data Sheet
If this product is combined with other materials, deteriorates, or becomes contaminated, it may pose hazards not mentioned in this SDS.
7.
file.medchemexpress.com
file.medchemexpress.com/batch_PDF/HY-15592/Cabotegravir-SDS-MedChemExpress.pdfSafety Data Sheet
P264 Wash hands thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P271 Use only outdoors or in a well- ...
APRETUDE▼ (cabotegravir) Safety
THE SAFETY OF APRETUDE HAS BEEN INVESTIGATED IN >3,500 STUDY PARTICIPANTS GLOBALLY · APRETUDE is generally well tolerated with low discontinuation rates · Grade 2 ...
safety established in 2 clinical trials
The most common adverse reactions (incidence ≥1%, all grades) with APRETUDE were injection site reactions, diarrhea, headache, pyrexia, fatigue, sleep ...
10.
clinicalinfo.hiv.gov
clinicalinfo.hiv.gov/en/guidelines/perinatal/safety-toxicity-arv-agents-integrase-inhibitors-cabotegravir-vocabriaAppendix B: Cabotegravir - Safety and Toxicity in Pregnancy
Clinical data are insufficient to characterize the risk for congenital anomalies associated with in utero exposure to CAB. No reproductive toxicity or ...
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