RECRUITING

A Clinical Trial of STP0404 in Adults with HIV-1 Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the antiviral effect, safety, tolerability, and pharmacokinetics of STP0404 in adult participants living with Human Immunodeficiency Virus Type 1 (HIV-1) infection.

Official Title

A Phase 2a, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Investigate the Antiviral Effect, Safety, Tolerability, and Pharmacokinetics of STP0404 in Adults with HIV-1 Infection

Quick Facts

Study Start:2023-05-23

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05869643

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Have a confirmed HIV-1 infection in the documented medical record or at screening. * Have never received any ARTs (i.e., treatment-naïve) before screening or only received one ARV regimen (2 or 3 drugs) at least 12 weeks before screening and/or received any monotherapy ≤10 days in a clinical trial setting at least 12 weeks before screening. Participants with a documented history of PrEP and/or PEP therapy but discontinued at least 8 weeks prior to screening are also eligible for inclusion. * Have a CD4+ cell count ≥200 cells/mm3 at screening.	* Have a hepatitis B surface antigen or positive hepatitis C virus antibody at screening. An HCV confirmation (HCV RNA test) will be performed at a central laboratory if the HCV antibodies screening result is positive. If the HCV RNA test result is negative, the participant will be eligible. * Have a positive drug screen for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, heroin, or phencyclidine. However, if in the opinion of the investigator, positive drug screen results may be due to prescription medication for therapeutic purposes (e.g., prescription Adderall for ADHD), eligibility decision shall rely on the investigator's medical judgment and should be documented. * Have a history of regular alcohol consumption, defined as an average weekly intake of \>14 drinks (males) or \>7 drinks (females), within 6 months of screening and/or has positive alcohol screen at screening and baseline. * Have received the following treatments as PrEP or PEP (≥1 dose) prior to screening: monoclonal antibodies, HIV-1 maturation inhibitors, and long-acting INSTIs (such as cabotegravir). * Pregnant or lactating females. * Have a history of clinically relevant pancreatitis or hepatitis within the previous 6 months. * Participant received any allosteric HIV-1 integrase inhibitor (ALLINI, ≥1 dose) and/or received any long-acting ARVs (marketed or investigational, ≥1 dose) prior to screening. * Have previously failed an INSTIs-containing regimen.

Inclusion Criteria

Exclusion Criteria

* Have a confirmed HIV-1 infection in the documented medical record or at screening.
* Have never received any ARTs (i.e., treatment-naïve) before screening or only received one ARV regimen (2 or 3 drugs) at least 12 weeks before screening and/or received any monotherapy ≤10 days in a clinical trial setting at least 12 weeks before screening. Participants with a documented history of PrEP and/or PEP therapy but discontinued at least 8 weeks prior to screening are also eligible for inclusion.
* Have a CD4+ cell count ≥200 cells/mm3 at screening.

* Have a hepatitis B surface antigen or positive hepatitis C virus antibody at screening. An HCV confirmation (HCV RNA test) will be performed at a central laboratory if the HCV antibodies screening result is positive. If the HCV RNA test result is negative, the participant will be eligible.
* Have a positive drug screen for amphetamines, barbiturates, cocaine, opiates, benzodiazepines, heroin, or phencyclidine. However, if in the opinion of the investigator, positive drug screen results may be due to prescription medication for therapeutic purposes (e.g., prescription Adderall for ADHD), eligibility decision shall rely on the investigator's medical judgment and should be documented.
* Have a history of regular alcohol consumption, defined as an average weekly intake of \>14 drinks (males) or \>7 drinks (females), within 6 months of screening and/or has positive alcohol screen at screening and baseline.
* Have received the following treatments as PrEP or PEP (≥1 dose) prior to screening: monoclonal antibodies, HIV-1 maturation inhibitors, and long-acting INSTIs (such as cabotegravir).
* Pregnant or lactating females.
* Have a history of clinically relevant pancreatitis or hepatitis within the previous 6 months.
* Participant received any allosteric HIV-1 integrase inhibitor (ALLINI, ≥1 dose) and/or received any long-acting ARVs (marketed or investigational, ≥1 dose) prior to screening.
* Have previously failed an INSTIs-containing regimen.

Contacts and Locations

Study Locations (Sites)

Kaiser Permenente Los Angeles Medical Center

Los Angeles, California, 90027

United States

Ruane Clinical Research, Inc.

Los Angeles, California, 90036

United States

Midway Immunology and Research Center

Fort Pierce, Florida, 34982

United States

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, 33136-2107

United States

Orlando Immunology Center

Orlando, Florida, 32803

United States

USF Health South Tampa Center for Advanced Healthcare

Tampa, Florida, 33602-3511

United States

Be Well Medical Center

Berkley, Michigan, 48072

United States

Saint Michael's Medical Center

Newark, New Jersey, 07102

United States

South Jersey Infectious Disease

Somers Point, New Jersey, 08244

United States

North Shore University Hospital

Manhasset, New York, 11030-3816

United States

Atrium Health Wake Forest Baptist Medical Center - PPDS

Winston-Salem, North Carolina, 27157

United States

St Hope Foundation, Inc

Bellaire, Texas, 77401

United States

North Texas Infectious Diseases Consultants, P.A.

Dallas, Texas, 75246

United States

Collaborators and Investigators

Sponsor: ST Pharm Co., Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-23

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-05-23

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

HIV-1-infection