Colorado Infectious Diseases Clinical Trials Unit (IDCTU)

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

ISLEND-1: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 (COMIRB: 24-1762)

A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF)

The goal of this clinical study is to learn more about the safety and efficacy of switching to a once weekly tablet of islatravir/lenacapavir regimen versus continuing standard of care treatment in people with human immunodeficiency virus who are virologically suppressed on a stable standard of care regimen prior to screening.

Main Inclusion/Exclusion Criteria:

HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening
Individuals are receiving B/F/TAF for ≥ 6 months prior to screening and willing to continue until Day 1

ClinicalTrials.gov: Study Details | Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Bictegravir/Emtricitabine/Tenofovir Alafenamide in Virologically Suppressed People With HIV-1 | ClinicalTrials.gov

ISLEND-2: Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (COMIRB: 24-1828)

A Phase 3, Randomized, Open-Label, Active-Controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Standard of Care

The goal of this clinical study is to learn about the safety and efficacy of switching to once weekly tablet of islatravir/lenacapavir regimen versus continuing standard treatment of bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in people with human immunodeficiency virus who are virologically suppressed on B/F/TAF prior to screening.

Main Inclusion Criteria:

HIV-1 RNA < 50 copies/mL for ≥ 6 months before screening
Are receiving guideline-recommended standard of care treatment

ClinicalTrials.gov: Study Details | Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 | ClinicalTrials.gov

CROWN: A Phase 3b, open label, randomized, standard-of-care control arm, multicenter, superiority study evaluating the efficacy, safety and tolerability of injectable CAB LA + RPV LA in viremic participants living with HIV-1 (COMIRB: 24-1607)

A Phase 3b, Open Label, Randomized, standard-of Care Control Arm, Multicenter, Superiority Study Evaluating the Efficacy, Safety, and Tolerability of Injectable CAB LA + RPV LA in Viremic Participants Living With HIV-1

This study will assess how effective, safe, and long-lasting a long-acting antiretroviral therapy using CAB LA + RPV LA is for people with HIV who still have detectable virus levels despite being on oral ART. The study will also consider feedback from patients on their experience with this treatment.

Main Inclusion Criteria: