Cabotegravir Injections for HIV Prevention
(CHIPP-PrEP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how a long-acting injection called cabotegravir (CAB-LA) can help prevent HIV. Researchers aim to understand how this treatment interacts with natural and prescribed hormones and whether participants experience any side effects. It suits individuals who are HIV-negative, weigh more than 77 pounds, and are willing to use condoms during the study period. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that cabotegravir injections are likely to be safe for humans?
Research has shown that cabotegravir injections (CAB-LA) are generally safe for preventing HIV. Many people tolerate CAB-LA well, and it effectively lowers the risk of contracting HIV. For example, one study found it reduced the risk by 79% compared to another treatment.
Few safety concerns have been reported. Some studies found CAB-LA safe for various groups, including cisgender men and women and transgender women. The FDA has approved the treatment for preventing HIV, indicating a strong safety record. However, like any treatment, some risks may exist, so discussing these with a healthcare provider is important.12345Why do researchers think this study treatment might be promising?
Unlike the standard HIV prevention methods like daily oral PrEP (Pre-exposure prophylaxis) such as Truvada or Descovy, Cabotegravir Injectable Suspension (CAB LA) offers a unique approach with its long-acting injectable form. Researchers are excited because this treatment can be administered once every two months, eliminating the need for daily pills and potentially improving adherence. Additionally, Cabotegravir works as an integrase inhibitor, which prevents the virus from integrating into the host's DNA, offering a different mode of action compared to other preventive treatments. This combination of a new delivery method and mechanism of action makes it a promising option for those seeking a more convenient and effective way to prevent HIV infection.
What evidence suggests that cabotegravir might be an effective treatment for HIV prevention?
Research has shown that long-acting cabotegravir (CAB-LA), which participants in this trial will receive, effectively prevents HIV. In studies, CAB-LA reduced the risk of contracting HIV by 79% compared to daily pills. It also outperformed oral PrEP (pre-exposure prophylaxis) in preventing HIV. Among various groups, CAB-LA lowered HIV infections by 66% to 89%. This treatment is safe, well-accepted, and removes the need for daily pills.46789
Who Is on the Research Team?
Mark A Marzinke
Principal Investigator
Johns Hopkins School of Medicine
Are You a Good Fit for This Trial?
This trial is for people interested in HIV prevention who may be taking hormone therapy or have natural hormone changes. Participants should not already have HIV and must meet other health requirements set by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Pre-treatment evaluations including hormone concentration assessments, HIV testing, and baseline biopsies
Treatment
Administration of a single 3 mL intramuscular injection of 600 mg cabotegravir long-acting injectable suspension
Follow-up
Participants are monitored for safety and effectiveness after treatment, including final safety visit
What Are the Treatments Tested in This Trial?
Interventions
- Cabotegravir Injectable Suspension (CAB LA)
Trial Overview
The study is testing long-acting cabotegravir injections (CAB-LA) to see how well they prevent HIV, especially in people with different hormone levels or those on hormone treatments. Researchers will monitor drug levels and any medical issues during the trial.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Citations
Trial results reveal that long-acting injectable cabotegravir ...
These results show that CAB LA is significantly more effective in preventing HIV acquisition than oral PrEP in an intention-to-treat analysis from this trial.
Safety and efficacy of long-acting injectable cabotegravir as ...
CAB-LA is safe and highly effective for HIV prevention across studied populations and settings, demonstrating a 79% reduction in HIV risk compared to TDF-based ...
User‐reported outcomes of long‐acting injectable PrEP ...
Convenience and elimination of daily pill-taking were valued by >94%. Self-reported adherence improved in 75.3%. Side effects were mostly mild ...
4.
journals.lww.com
journals.lww.com/aidsonline/fulltext/2023/05010/safety_and_efficacy_of_long_acting_injectable.13.aspxSafety and efficacy of long-acting injectable cabotegravir...
CAB-LA is safe and highly effective for HIV prevention across studied populations and settings, demonstrating a 79% reduction in HIV risk ...
Long-Acting Injectable Cabotegravir for HIV Prevention - PMC
CAB-LA demonstrated a 66% reduction in HIV infection among transwomen and men who have sex with men (MSM) at multiple global sites and an 89% ...
WHO recommends long-acting cabotegravir for HIV ...
CAB-LA was shown to be safe and highly effective among cisgender women, Together, these landmark studies found that use of CAB-LA resulted in a ...
Injectable Cabotegravir for PrEP
Safety Found to be safe and effective for cisgender men and women and transgender women; Initial data suggests that CAB for PrEP is well- ...
Cabotegravir Long-Acting Injectable (CAB-LA) for HIV PrEP
Every 8 weeks after initial dose are 4 weeks apart) ~36-month safety issues were observed. Based on positive safety data so far … data on safety during ...
9.
hptn.org
hptn.org/sites/default/files/inline-files/HPTN%20083-01_Version%202.0_dated%2023Aug2020.pdfHPTN 083-01: Safety, Tolerability and Acceptability of Long ...
Pre-exposure prophylaxis (PrEP) containing long-acting injectable cabotegravir (CAB-LA) is safe and highly effective for cisgender men and ...
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