STP0404 for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called STP0404 (Pirmitegravir) to evaluate its effectiveness against HIV-1, a virus that attacks the immune system. The study will also assess the treatment's safety and tolerability. Participants will be divided into groups, with some receiving the new treatment and others a placebo (a substance with no active drug), to compare results. This trial targets adults living with HIV-1 who have either never been treated or have only had limited treatment in the past. Participants must have an immune cell count (CD4+) of 200 or more to be eligible. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it seems to focus on those who have not received certain HIV treatments recently. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that STP0404 (Pirmitegravir) is likely to be safe for humans?
Research has shown that STP0404, also known as Pirmitegravir, has promising safety results from earlier studies. One study found that participants tolerated Pirmitegravir well. In this study, participants took the treatment for ten days and experienced a significant drop in the virus, with no major safety issues reported. These findings suggest that STP0404 is relatively safe for humans so far. However, like any new treatment, ongoing and future research will confirm its safety.12345
Why do researchers think this study treatment might be promising for HIV?
Researchers are excited about STP0404 (Pirmitegravir) for HIV because it offers a new mechanism of action compared to current treatments. While most standard HIV therapies use integrase inhibitors like Dolutegravir or Bictegravir, STP0404 is a novel integrase inhibitor that targets the virus differently, potentially offering a fresh approach to combat resistance. This new active ingredient could provide an alternative for patients who have limited options due to resistance or side effects from existing drugs. The promise of a new pathway to suppress the virus is what makes STP0404 particularly compelling for researchers.
What evidence suggests that STP0404 might be an effective treatment for HIV?
Research shows that STP0404, also known as Pirmitegravir, has promising results in treating HIV-1. Studies have found that the drug significantly lowers the amount of virus in the blood after just ten days of treatment, indicating reduced viral activity and a positive sign for controlling the infection. In this trial, participants in the experimental arms will receive STP0404, while others will receive a placebo. Reports indicate that Pirmitegravir is well-tolerated by patients, causing few side effects. Overall, these findings suggest that STP0404 could effectively manage HIV-1.12346
Are You a Good Fit for This Trial?
This trial is for adults who have been diagnosed with HIV-1 and haven't started any antiretroviral therapy. People who've had PrEP or PEP (except monoclonal antibodies and INSTI like cabotegravir) can join if they stopped these treatments at least 8 weeks before screening.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive STP0404 or placebo for 10 days to evaluate antiviral effect, safety, tolerability, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- STP0404 (Pirmitegravir)
Find a Clinic Near You
Who Is Running the Clinical Trial?
ST Pharm Co., Ltd.
Lead Sponsor