PDS0101 for HIV
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called PDS0101 for individuals with HIV who also have HPV type 16, a virus that can lead to cancer. The goal is to determine if PDS0101 is safe and aids the immune system in fighting HPV 16. Participants will receive three doses of the treatment and will be closely monitored for side effects. The study seeks individuals who have been on HIV medication for at least a year, have low levels of the HIV virus, and have HPV 16 detected in specific areas. Participants may have high-grade lesions, which are cell changes that could become cancerous, but this is not required. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you must have been on antiretroviral therapy for at least 12 months. Some medications, like immune suppressants or certain vaccines, may not be allowed, so it's best to discuss your specific medications with the study team.
Is there any evidence suggesting that PDS0101 is likely to be safe for humans?
Research has shown that PDS0101 has been well tolerated in earlier studies. One study combined PDS0101 with pembrolizumab and found the combination to be safe without major side effects. This suggests that PDS0101 alone might also be safe for people.
Since this trial is in Phase 2, previous tests have already provided some evidence of PDS0101's safety. However, each new study examines the potential for serious or unexpected side effects. Ensuring participant safety remains a top priority, and researchers will closely monitor any severe side effects.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for HIV, which primarily focus on antiretroviral therapy to suppress the virus, PDS0101 is unique because it is an immunotherapeutic agent targeting HPV 16. This means it aims to enhance the body's immune response specifically against the human papillomavirus, potentially addressing complications related to HPV in HIV-positive individuals more directly. Researchers are excited about PDS0101 because it represents a novel approach by harnessing the immune system, which might offer benefits beyond viral suppression and could lead to improved outcomes for patients with both HIV and HPV-related conditions.
What evidence suggests that PDS0101 might be an effective treatment for HPV 16 in people living with HIV?
Research has shown that PDS0101, an immunotherapy treatment, can help the immune system combat HPV infections. In other studies, combining PDS0101 with pembrolizumab, a cancer treatment, produced promising results by extending the lives of patients with HPV-related head and neck cancers. Specifically, some patients lived for an average of 39.3 months. This suggests that PDS0101 effectively strengthens the body's defense against HPV-related diseases. Early results for PDS0101 alone, the focus of this trial, are also encouraging, as it can activate the immune system against HPV type 16, which is linked to certain cancers. These findings support the potential of PDS0101 in treating HPV-related conditions.16789
Who Is on the Research Team?
Grant Ellsworth, MD, MS
Principal Investigator
Weill Medical College of Cornell University
Timothy Wilkin, MD, MPH
Principal Investigator
University of California, San Diego
Are You a Good Fit for This Trial?
Adults aged 25-65 living with HIV and HPV type 16, on antiretroviral therapy for at least a year, with CD4 count ≥200 cells/mm³ and viral load <200 copies/mL. Participants must have HPV detected in the cervix, vagina, or anus; some may have high-grade lesions that could lead to cancer.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive three doses of the PDS0101 vaccine
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- PDS0101
Find a Clinic Near You
Who Is Running the Clinical Trial?
Weill Medical College of Cornell University
Lead Sponsor
Albert Einstein College of Medicine
Collaborator
University of Puerto Rico
Collaborator
University of California, San Diego
Collaborator
H. Lee Moffitt Cancer Center and Research Institute
Collaborator
Emory University
Collaborator
University of Maryland, Baltimore
Collaborator
Montefiore Medical Center
Collaborator
University of Sao Paulo
Collaborator
National Cancer Institute (NCI)
Collaborator