Learn more about the study at ClinicalTrials.gov

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Turn Your HIV Positive Status Into Something Positive

Help Find the Next
HIV Treatment Breakthrough

There’s something newly HIV positive people can do to join the fight against HIV, even before beginning traditional standard-of-care treatment. They can join a clinical study assessing the safety and effectiveness of a new class of HIV treatment called allosteric HIV-1 inhibitor (ALLINI).

With your help, we hope to continue making advancements that improve treatment options for the future of people living with HIV (PLHIV).

Turn Your HIV Positive Status Into Something Positive

Help Find the Next
HIV Treatment Breakthrough

There’s something newly HIV positive people can do to join the fight against HIV, even before beginning traditional standard-of-care treatment. They can join a clinical study assessing the safety and effectiveness of a new class of HIV treatment called allosteric HIV-1 inhibitor (ALLINI).

With your help, we hope to continue making advancements that improve treatment options for the future of people living with HIV (PLHIV).

Learn more about the study at ClinicalTrials.gov

There’s something newly HIV positive people can do to join the fight against HIV, even before beginning traditional standard-of-care treatment. They can join a clinical study assessing the safety and effectiveness of a new class of HIV treatment called allosteric HIV-1 inhibitor (ALLINI).

With your help, we hope to continue making advancements that improve treatment options for the future of people living with HIV (PLHIV).

The SToPHIV-1
Clinical Study Is
Enrolling Now!

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If you are newly diagnosed with HIV-1 or if you are a healthcare provider in position to recommend this study, participants may receive:

  • Compensation for participation.
  • No-cost study-related care.
  • One-month support of Standard-of-Care treatment.

Learn more about the study Click Here.

Get The Facts

The ST PHARM SToPHIV-1 Study

Human immunodeficiency virus type 1 (HIV-1) is a retrovirus that weakens the immune system. Worldwide, as of 2017, about 37 million people had HIV1, with roughly 40% not on any treatment2.

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Per the CDC, in 2021, some 36,136 people ages 13+ received an HIV diagnosis in the U.S. and dependent areas. In terms of race, 40% were Black/African American; 29% were Hispanic/Latino, and 25% were White—which is why diversity in clinical trials is key to ensuring that new drugs will work for everyone3.

United States Outlined

In total, 1.2 million people in the U.S. were believed to have HIV by the end of 2021. Of those, 87% knew they had it—which means that 13% remained undiagnosed3.

1. Justiz Vaillant AA, Naik R. HIV-1 associated opportunistic infections. [Updated 2022 May 4]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK539787/

2. GBD 2017 HIV collaborators. Global, regional, and national incidence, prevalence, and mortality of HIV, 1980-2017, and forecasts to 2030, for 195 countries and territories: a systematic analysis for the Global Burden of Diseases, Injuries, and Risk Factors Study 2017. Lancet HIV. 2019;6(12):e831-59.

3. https://www.cdc.gov/hiv/basics/statistics.html

About The Study

  • STP0404, an investigational medication, belongs to a NEW group of drugs known as HIV allosteric integrase inhibitors (ALLINIs). To block the growth of the virus, it works by attaching to a protein that HIV needs in order to make copies of itself.
  • STP0404 has already been tested in animals and in healthy adult volunteers—now we need to assess it in adults with HIV who have never been on ART treatment*. Though not yet approved, this study may offer you the potential to receive a promising treatment early.
  • The development of new HIV drugs is critical because the current Standard of Care (SoC) in the U.S. is a combination of antiretroviral drugs called ART, for short. But there are concerns around these drugs’ toxicity (how well-tolerated they are), their limited ability to be given in long-acting forms, and growing drug resistance (i.e., that they may stop working).

* NOTE: Those who have taken PrEP and/or PEP therapy may still qualify to enroll if they meet specific conditions. This can be discussed with the Principal Investigator.

The Study Consists of 3 Periods

Welcome Guide

Download the Welcome Guide for more details about this study and your responsibilities.

Did you know?

All study-related care and study-related medication will be provided at no cost to the participant.

Find a Participating Site

Learn more about the study at ClinicalTrials.gov

Kaiser Permenente

Los Angeles Medical Center

Los Angeles, California 90027

 

Ruane Clinical Research, Inc.

Los Angeles, California 90036

Kaiser Permenente

Los Angeles Medical Center

Los Angeles, California 90027

 

Ruane Clinical Research, Inc.

Los Angeles, California 90036

 

USF Health South Tampa Center For Advanced Healthcare

Tampa, FL 33602-3511

Be Well Medical Center

Berkley, Michigan 48072

Saint Michael’s Medical Center

Newark, New Jersey 07102

 

South Jersey Infectious Disease

Somers Point, New Jersey 08244

North Shore University Hospital

Manhasset, NY 11030

Atrium Health Wake Forest Baptist Medical Center – PPDS

Winston-Salem, North Carolina 27157

St Hope Foundation, Inc

Bellaire, Texas 77401

 

North Texas Infectious Diseases Consultants, P.A.

Dallas, Texas 75246

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Study Details & Resources

Find useful information about STP0404

For Clinicians:

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The science behind STP0404 and
ALLINIs at NIH.gov

Ultimately, the results of this study will be provided to regulatory authorities as part of an approval process. Results will also be used to guide future studies and further characterize the study medication’s benefit/risk profile.
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AcurianHealth helps connect people with research studies that offer treatment under development. Since 1998, AcurianHealth has referred 1 million study candidates to 800 studies in 70 countries.

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*In a research study, the participants may receive investigational study product or may receive an inactive substance, or placebo, depending on the study design. Participants receive study-related care from a doctor/research team for the duration of the study. For studies that offer compensation, reasonable payments will be made for participation. The length of the study may vary.