Injectable Cabotegravir for HIV Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and effectiveness of an injectable drug called cabotegravir for preventing HIV in uninfected individuals. The study focuses on cisgender men and transgender women who have sex with men and are at high risk for HIV. Participants will receive either cabotegravir or an alternative treatment, and researchers will compare the results. Those who have had condomless sex, multiple partners, or recently used stimulant drugs might be suitable for this trial. As a Phase 2, Phase 3 trial, this study is crucial for assessing how well cabotegravir works and serves as the final step before potential FDA approval, offering participants a chance to contribute to groundbreaking HIV prevention research.
Do I need to stop my current medications to join the trial?
The trial information does not clearly state if you need to stop your current medications. However, it mentions that active or planned use of certain prohibited medications, as described in the study documents, may exclude you from participation. It's best to discuss your current medications with the study team to see if they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that cabotegravir (CAB LA) is a safe and effective method for preventing HIV. Studies have found that this injectable medicine is generally well-tolerated with few safety issues. Although there is a small chance of developing resistance to a type of HIV medicine called INSTI, it is overall considered safe.
For those taking cabotegravir in pill form, safety data from both teenagers and adults have shown similar results, indicating that the treatment is generally safe across different age groups.
The FDA has already approved cabotegravir for preventing HIV, providing extra reassurance about its safety. This approval confirms that it has passed several tests to ensure its safety and effectiveness for this purpose.12345Why are researchers excited about this trial's treatments?
Researchers are excited about injectable Cabotegravir for HIV prevention because it offers a long-acting alternative to daily oral medications like TDF/FTC, which are current standard options. Cabotegravir is administered as an injection every two months, providing a more convenient option for those who struggle with daily pill regimens. This treatment has a unique mechanism as it maintains therapeutic drug levels in the body for extended periods, potentially enhancing adherence and reducing the risk of HIV transmission. This novel approach could revolutionize HIV prevention by offering a more user-friendly and discreet way to stay protected.
What evidence suggests that this trial's treatments could be effective for HIV prevention?
Research shows that injectable cabotegravir (CAB LA), which participants in this trial may receive, effectively prevents HIV. Studies have found it can lower the risk of HIV infection by 79% to 92% compared to not using any preventive treatment, significantly reducing the chances of contracting HIV. CAB LA has also proven more effective than daily oral pills, specifically tenofovir disoproxil fumarate plus emtricitabine (TDF/FTC), another treatment option in this trial, for preventing HIV. These findings support its effectiveness for pre-exposure prophylaxis (PrEP) in people at risk.678910
Who Is on the Research Team?
Raphael J. Landovitz, MD, MSc
Principal Investigator
University of California, Los Angeles
Are You a Good Fit for This Trial?
This trial is for HIV-uninfected cisgender men and transgender women who have sex with men, are at high risk of acquiring HIV, and in general good health. Participants must be willing to consent, have a negative HIV test, no significant liver disease or cardiovascular issues, not use illicit intravenous drugs recently or be on certain medications that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Step 1
Participants receive daily oral CAB or TDF/FTC and corresponding placebo for 5 weeks
Step 2
Participants receive CAB LA injections every 8 weeks or TDF/FTC with placebo injections to Week 153
Step 3
All participants receive daily oral TDF/FTC for 48 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cabotegravir
- TDF/FTC
Trial Overview
The trial is testing cabotegravir (CAB LA), an injectable drug for pre-exposure prophylaxis (PrEP) against HIV. It compares CAB LA's safety and effectiveness to TDF/FTC tablets (current PrEP standard). Some participants will receive placebos instead of active drugs as part of the study design.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
In Step 1, participants will receive daily oral TDF/FTC and daily oral CAB placebo for 5 weeks. In Step 2, participants will receive daily oral TDF/FTC and placebo for CAB LA to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.
In Step 1, participants will receive daily oral CAB and daily oral TDF/FTC placebo for 5 weeks. In Step 2, participants will receive CAB LA and daily oral TDF/FTC placebo to Week 153. In Step 3, participants will receive daily oral TDF/FTC starting at Week 153 and for 48 weeks.
Cabotegravir is already approved in European Union, United States, Canada, Japan for the following indications:
- HIV-1 infection
- HIV-1 infection
- HIV-1 infection
- HIV-1 infection
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor
ViiV Healthcare
Industry Sponsor
Dr. Harmony Garges
ViiV Healthcare
Chief Medical Officer
MD
Deborah Waterhouse
ViiV Healthcare
Chief Executive Officer since 2017
Bachelor's degree in Business Administration
Gilead Sciences
Industry Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Citations
1.
viivhealthcare.com
viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/july/daily-pills-after-achieving-rapid-viral-suppression/ViiV Healthcare data show 89% of treatment-naïve people ...
97.7% of participants maintained virologic suppression at last known viral load at Month 24 or at discontinuation. In Europe, the COMBINE-2 ...
Safety and efficacy of long-acting injectable cabotegravir as ...
Our review suggests that CAB-LA is safe and highly effective for HIV prevention across studied populations and settings, demonstrating a 79% reduction in HIV ...
3.
viivhealthcare.com
viivhealthcare.com/hiv-news-and-media/news/press-releases/2025/july/long-acting-injectables-for-hiv-at-ias-2025/ViiV Healthcare presents new data demonstrating positive ...
24-month outcomes of cabotegravir+rilpivirine long-acting every 2 months in a real‑world setting: effectiveness, adherence to injections, and ...
Efficacy and safety of long-acting cabotegravir compared ...
Injectable cabotegravir was superior to daily oral tenofovir disoproxil fumarate plus emtricitabine for HIV prevention in two clinical trials.
Indirect Treatment Comparison of Long-Acting Injectable ...
The ITC of cabotegravir versus no PrEP estimated the mean (CrI) effectiveness in reducing HIV acquisition to be 92% (84.13–96.40) in men who ...
Safety and efficacy of long-acting injectable cabotegravir as ...
CAB-LA is highly efficacious for HIV prevention with few safety concerns. CAB-LA may lead to an increased risk of INSTI resistance.
7.
gskpro.com
gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Vocabria/pdf/VOCABRIA-PI-PIL.PDFVOCABRIA (cabotegravir) tablets, for oral use
Clinical Trials Experience in Adolescents: In adolescents receiving VOCABRIA for HIV-1 PrEP, the safety data were comparable to the safety data reported in ...
VOCABRIA (cabotegravir) tablets, for oral use
In adolescents receiving VOCABRIA for HIV-1 PrEP, the safety data were comparable to the safety data reported in adults receiving VOCABRIA for HIV-1 PrEP [see ...
9.
clinicalinfo.hiv.gov
clinicalinfo.hiv.gov/en/guidelines/perinatal/safety-toxicity-arv-agents-integrase-inhibitors-cabotegravir-vocabriaAppendix B: Cabotegravir - Safety and Toxicity in Pregnancy
CAB-LA is FDA approved for HIV pre-exposure prophylaxis (PrEP). Human Studies in Pregnancy. Pharmacokinetics. Prospective CAB PK data during pregnancy and ...
Safety, tolerability, and acceptability of long-acting ...
Interpretation. Long-acting injectable cabotegravir is a safe, tolerable, and acceptable option for the prevention of HIV in adolescent girls.
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