STP0404 for HIV

Recruiting at 13 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: ST Pharm Co., Ltd.

Must not be taking: Monoclonal antibodies, HIV-1 maturation inhibitors

Disqualifiers: Hepatitis B, Hepatitis C, Alcohol use, others

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called STP0404 to see if it can help people with HIV-1 who haven't had any treatment yet. The study will check if the drug can lower virus levels in the body and if it is safe and well-tolerated by patients.

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.

Eligibility Criteria

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

I have HIV but haven't started treatment, though I may have used PrEP or PEP, excluding certain drugs, and stopped 8 weeks ago.

Have a confirmed HIV-1 infection in the documented medical record or at screening

Exclusion Criteria

I have been drinking more than the recommended weekly alcohol limit in the past 6 months.

Have a positive drug screen for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, heroin, or phencyclidine

I tested positive for hepatitis B or C, but if my further tests are negative, I can join.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive STP0404 or placebo for 10 days to evaluate antiviral effect, safety, tolerability, and pharmacokinetics

10 days

Daily visits for 10 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• STP0404 (Pirmitegravir) (Integrase Inhibitor)

Trial Overview The study tests the effects of different doses of a new drug called STP0404 (Pirmitegravir) against a placebo in people with HIV-1. It aims to see how well the drug works, its safety, how it's tolerated by patients, and how it moves through the body.

Participant Groups

Group I: Cohort 3 STP0404 Experimental Treatment 1 Intervention

Group II: Cohort 2 STP0404 Experimental Treatment 1 Intervention

Group III: Cohort 1 STP0404 Experimental Treatment 1 Intervention

Group IV: Cohort 2 Placebo Group 1 Intervention

Group V: Cohort 3 Placebo Group 1 Intervention

Group VI: Cohort 1 Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

ST Pharm Co., Ltd.

Lead Sponsor

Trials

2

Recruited

70+