Woman researcher looking at test tube samples.

Clinical Research

Today’s Commitment. Tomorrow’s Cure.

The Clinical Research Program at Prism Health North Texas was created after the Peabody Health Center was awarded a seven-year grant to be a network clinical research site (CRS) of National Institutes of Health’s (NIH) AIDS Clinical Trials Group (ACTG) in 2006. In 2007, the organization began to partner with pharmaceutical companies to participate in industry-sponsored clinical trials. The Clinical Research Program has focused on research studies for HIV treatment, HIV Prevention, Hepatitis C Treatment, TB Prevention, and HIV co-morbidities such as HIV and Aging, HIV-associated neurocognitive disorders, and cardiovascular disease in patients living with HIV.

Featured Study: IMPOWER - Oral PrEP for Women

The IMPOWER study tests the efficacy of islatravir, an investigational drug developed by Merck as a once-monthly oral tablet for PrEP (pre-exposure prophylaxis) for women. PrEP refers to the use of medications to prevent the spread of the human immunodeficiency virus (HIV-1) to people who may be at risk of acquiring HIV.
Participants will be compensated for their time and all study medication and study-related tests will be provided at no cost.

You may be able to participate in the study if you: 

  • Are a cisgender women age 18-45 who do not have HIV, have been sexually active with at least one male partner in the past 30 days, are not in a mutually monogamous relationship with a recently tested HIV-negative partner, and meet at least one of the following:
    • Infrequently use condoms during sex with 1 or more partners of unknown HIV status who are bisexual men or men who use intravenous drugs.
    • In an ongoing sexual relationship with an HIV-positive partner.
    • Diagnosed with syphilis, gonorrhea, or chlamydia in the past 6 months.
Complete Study Interest Form
Black female provider with tablet talking to Asian female patient

Current Enrolling Studies

 

IMPOWER – Oral PrEP for Women
  • MK-8591-022: The IMPOWER study is being conducted to learn if an investigational medication called islatravir taken as a pill once a month can help prevent women from contracting HIV.
  • We’re looking for:
  • Cisgender women age 18-45 who do not have HIV, have been sexually active with at least one male partner in the past 30 days, are not in a mutually monogamous relationship with a recently tested HIV-negative partner, and meet at least one of the following:
      • Infrequently use condoms during sex with 1 or more partners of unknown HIV status who are bisexual men or men who use intravenous drugs.
      • In an ongoing sexual relationship with an HIV-positive partner.
      • Diagnosed with syphilis, gonorrhea, or chlamydia in the past 6 months.

 

SOLAR – HIV Injectable Treatment
  • GSK 213500: This study is designed to assess the antiviral activity and safety of switching from Biktarvy to a two-drug regimen of long-acting cabotegravir and rilpivirine administered via intramuscular injection every 2 months.
  • We’re looking for:
    • Are at least 18 years old.
    • Have been diagnosed with HIV that is controlled (suppressed) by your current HIV medications.
    • Have been on the same HIV medications and doses for at least 6 months (approximately).
    • There are other requirements that the study doctor will review with you.

 

Janssen DEFINE – HIV Medication Switch Study
  • Janssen DEFINE: The purpose of this study is to assess the percent change in body weight when switching to darunavir/cobicistat/emtricitabine/tenofovir alafenamide fixed-dose combination compared to continuing the current integrase + tenofovir alafenamide/emtricitabine antiretroviral regimen in virologically-suppressed PLWH who have experienced rapid and significant body weight gain.
  • We’re looking for:
    • People living with HIV who have experienced a greater than 10% increase in body weight within a 12 month period of time while on current integrase inhibitor plus tenofovir alafenamide/emtricitabine antiretroviral regimen.
    • BMI greater than or equal to 18 kilogram per meter square at time of starting an integrase-based regimen plus tenofovir alafenamide/emtricitabine antiretroviral regimen.
    • Documented evidence of being virologically suppressed while on the current regimen prior to screening with at least one plasma HIV-1 RNA measurement less than 50 copies occurring between 12 and 2 months prior to the screening visit on current regimen.

 

EvoGuard – EVO100 Vaginal Gel
  • EVO100-311: This study will evaluate whether EVO100 vaginal gel prevents the sexual transmission of gonorrhea and chlamydia in cisgender women.
  • We’re looking for cisgender women recently diagnosed with gonorrhea and/or chlamydia with one of the following risk factors:
    • 18 to 24 years of age at the screening visit.
    • New sex partner within the past 12 weeks (84 days).
    • More than one current sex partner.
    • The knowledge that current sex partner has multiple partners.
    • Partner with known sexually transmitted infection (STI).
    • Inconsistent condom use among persons who are not in a mutually monogamous relationship.

Interested in being a participant in one of the current enrolling studies?

Active Studies

COVID-19 Vaccine Study
  • AZD1222is an investigational vaccine being developed by AstraZeneca to prevent COVID-19, the disease caused by the SARS-CoV-2 virus.

The vaccine is based on a weakened version of a common cold (adenovirus) virus. The adenovirus vaccine has been changed so that it can’t replicate inside your body. It presents part of the COVID-19 spike protein to the body so that an immune response can be made to it. The purpose of the study is to test how well the investigational vaccine works at preventing COVID-19 disease and how safe it is.

 

HIV Treatment Studies

Switch Studies for those suppressed on current treatment:

  • M19-939999: A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of ABBV-181 (Budigalimab) in Adult Participants With HIV-1

Switch studies for those who have trouble taking medication or with medication resistance:

  • GS-US-200-4625: Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination with an Optimized Background Regimen in Heavily Treatment Experienced Participants Living With HIV with Multidrug Resistance (CAPELLA)

 

STI Studies
  • 248C1: Clinical Evaluation of the Xpert Xpress Chlamydia & Gonorrhea Test in Male Urine and Extragenital Specimens

 

 

Research Publications

  • Comparable Viral Decay with Initial Dolutegravir Plus Lamivudine Versus Dolutegravir-Based Triple Therapy // Read More →
  • Hepatic Steatosis in People Living with HIV: Effect of Sex and Race/Ethnicity // Read More →

 

Be a Study Participant

PHNTX is honored to participate in the AIDS Clinical Trials Group, one of the largest HIV clinical trials organizations in the world, and is currently enrolling for the research studies listed above. If you are interested in being a part of a study, please contact our Clinical Research Department at research@prismntx.org.

Contact Clinical Research
Female Provider Drawing Blood from Male Patient

Community Advisory Board

The Research Program has an active Community Advisory Board (CAB) dedicated to community outreach and peer education. The CAB is made up of five men and two women who are passionate about HIV research, treatment, and prevention. The CAB meets every other month and reviews studies in the early phase of development to provide community feedback on the study’s design, which helps the sponsor improve study objectives, potential recruitment, and participant retention. The CAB also provides input on ways to recruit participants and keep them engaged while participating in a study.