CURRENT & UPCOMING STUDIES

The Colorado Infectious Diseases Clinical Trials Unit (IDCTU) is actively enrolling participants in clinical trials focusing on improving the management of HIV and its comorbidities, developing a cure for HIV; and innovative treatments for Hepatitis B, opportunistic infections and emerging infectious diseases. 

Please click here for a list of our currently enrolling ACTG Clinical Trials

ADDITIONAL AVAILABLE CLINICAL TRIALS

• PURPOSE 2
  

A Phase 3, Double-Blind, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of Subcutaneous Twice Yearly Long-Acting Lenacapavir for HIV Pre-Exposure Prophylaxis in Cisgender Men, Transgender Women, Transgender Men, and Gender Nonbinary People ≥ 16 Years of Age Who Have Sex With Male Partners and Are at Risk for HIV Infection

The goal of this clinical study is to test how well the study drug, lenacapavir (LEN), works in reducing the risk of HIV. 

Requirements to Enter Study: 

• Be at least 16 years of age.

• Not have had an HIV test in the past 3 months.

• No oral PrEP in the past 12 weeks or any prior use of long-acting systemic PrEP.

• Be a cisgender man, transgender or gender nonbinary individual who has receptive anal sex. 

ClinicalTrials.gov - https://classic.clinicaltrials.gov/ct2/show/NCT04925752 

Gilead Purpose 2 Website - https://www.purposestudies.com/purpose2/#questionnaire

• Characterization of Mpox Antibody Response after JYNNEOS Vaccination Amoung Persons with HIV (COMIRB# 23-0076)
  

The purpose of this study is to characterize monkeypox (mpox) antibodies and learn about the vaccination response. The research will include one blood draw at the start of the study. 

Main Inclusion/Exclusion Criteria: 

All adults greater than 18 years of age who are: 

• Living with HIV and completed the 2 doses of mpox vaccine series (with no history of mpox infection)

• Not living with HIV who either completed the 2 dose mpox vaccine, had mpox infection, or neither. 

One study visit. Compensation Provided. 

• A5418: A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Mpox Disease
  

A5418 (STOMP) is a study of tecovirimat (also known as TPOXX) for the treatment of human monkeypox virus (HMPXV) disease. 

Eligibility: Laboratory-confirmed or presumptive monkeypox infection 

ClinicalTrials.gov - https://clinicaltrials.gov/study/NCT05534984

Study Website - https://www.stomptpoxx.org/main

If you are interested in participating in or learning more about our clinical trials please contact

Vanessa Sutton, FNP-BC - 303-724-0712 or

Joslyn Axinn, RN - 303-724-0779