← Back to Search

Integrase Inhibitor

STP0404 for HIV

Phase 2

Recruiting

Research Sponsored by ST Pharm Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, day 2, day 4, day 7, day 10, day 11

Awards & highlights

Study Summary

This trial tests a new drug to treat HIV, to see if it's safe, effective, and how it affects the body.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects from STP0404 are not detailed but may include typical reactions to antiviral drugs such as headaches, nausea, fatigue, and potential liver toxicity. The exact side effects will be monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, day 2, day 4, day 7, day 10, day 11

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, day 2, day 4, day 7, day 10, day 11

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, day 2, day 4, day 7, day 10, day 11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HIV-1 RNA copies change in plasma

Mean apparent oral clearance (CL/F)

Mean apparent volume of distribution (Vd/F)

+9 more

Secondary outcome measures

CD4+ cell count change

Emergence of drug resistance mutations.

HIV-1 RNA change in plasma from baseline to nadir over 11 days.

+5 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Cohort 3 STP0404Experimental Treatment1 Intervention

Group II: Cohort 2 STP0404Experimental Treatment1 Intervention

Group III: Cohort 1 STP0404Experimental Treatment1 Intervention

Group IV: Cohort 3Placebo Group1 Intervention

Group V: Cohort 2Placebo Group1 Intervention

Group VI: Cohort 1Placebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ST Pharm Co., Ltd.Lead Sponsor

1 Previous Clinical Trials

32 Total Patients Enrolled

Media Library

STP0404 (Pirmitegravir) (Integrase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05869643 — Phase 2

HIV Research Study Groups: Cohort 3, Cohort 2, Cohort 2 STP0404, Cohort 1, Cohort 3 STP0404, Cohort 1 STP0404

HIV Clinical Trial 2023: STP0404 (Pirmitegravir) Highlights & Side Effects. Trial Name: NCT05869643 — Phase 2

STP0404 (Pirmitegravir) (Integrase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05869643 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are senior citizens eligible for this clinical trial?

"This trial has a strict age cutoff, with patients aged between 18 and 65 being eligible to participate."

Answered by AI

What potential hazards does Cohort 2 STP0404 present to individuals?

"Our experts have rated Cohort 2 STP0404 as a level 2 on the safety scale, considering that this is only Phase 2 and no efficacy has been tested yet."

Answered by AI

To what extent has enrollment been accepted for this clinical investigation?

"Affirmative. Information located on clinicaltrials.gov suggests that this medical research is actively recruiting patients. The trial was initially posted on May 23rd 2023 and subsequently updated just over 3 weeks later, June 13th 2023; 36 participants are needed for the study at a single site."

Answered by AI

Am I eligible to volunteer for this experiment?

"Potential participants must have a documented HIV diagnosis and be between 18-65 years of age to qualify for this trial. Recruitment is targeting a total 36 individuals."

Answered by AI

Has recruitment for this research commenced?

"Affirmative. The information listed on clinicaltrials.gov indicates that this investigation is actively seeking participants; it was initially posted to the site on May 23rd 2021 and its content was last modified June 13th 2021. In total, 36 patients are needed from a single location for this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Trial of STP0404 in Treatment-Naïve Adults With HIV-1 Infection

2023. "A Clinical Trial of STP0404 in Treatment-Naïve Adults With HIV-1 Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05869643.