Study on the Safety and Immune Effects of PDS0101, an Anti-HPV Therapy, in People Living with HIV

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT07090174

Provider View

This clinical trial is testing a new therapy called PDS0101 to see if it is safe and can help the immune system fight HPV type 16 in adults living with HIV. The study involves 27 participants who are on antiretroviral therapy and have HPV 16 detected in certain areas of the body.

Patient Parameters

Program Overview

The purpose of this study is to test a new treatment called PDS0101 in adults living with HIV who also have HPV type 16. Researchers want to find out if PDS0101 is safe and if it can help the immune system respond to HPV 16. The study will include 27 adults aged 25 to 65 who have been on antiretroviral therapy for at least a year, have a CD4 cell count of at least 200, and an HIV viral load below 200. Participants must have HPV 16 detected in the cervix, vagina, or anus, and some may have high-grade lesions that could lead to cancer. All participants will receive three doses of the PDS0101 vaccine, and the study will monitor for any side effects and measure the immune response. This research may help develop future strategies for preventing or treating HPV-related diseases in people with HIV.

Eligibility Criteria

Inclusion Criteria

  • Must have HPV 16 detected in the cervix, vagina, or anus within 90 days before joining the study.
  • For cervical HSIL group: Must have certain types of cervical lesions diagnosed within 90 days before joining the study and HPV 16 detected.
  • For anal HSIL group: Must have certain types of anal lesions diagnosed within 90 days before joining the study and HPV 16 detected.
  • Must be between 25 and 65 years old.
  • Must have HIV and have been on antiretroviral therapy for at least 12 months.
  • Must have a CD4+ T-cell count of at least 200 within 45 days before joining the study.
  • Must have an HIV viral load below 200 copies/mL within 45 days before joining the study.
  • Must meet certain blood and organ function criteria within 45 days before joining the study.
  • Must be willing to follow the study schedule and attend all visits.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for 120 days after the last dose.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Have had an AIDS-defining condition within 6 months before joining the study.
  • Have received blood products or are taking immune suppressants within 6 months before joining the study.
  • Have a history of HPV-related cancer or suspected cancer in certain areas.
  • Have a current cancer diagnosis or have had certain cancers requiring treatment in the past 3 years.
  • Have had surgical or ablative treatment for anal or cervical lesions within 180 days before joining the study.
  • Have received any HPV immunotherapy before.
  • Plan to use certain topical treatments for HPV within 90 days before joining the study.
  • Have received a live vaccine within 30 days before the first dose of treatment.
  • Have used certain immunotherapy or immunosuppressive agents within 6 weeks before the first dose of treatment.
  • Are participating in another study or have used an investigational device within 30 days before the first dose of treatment.
  • Are taking systemic steroids or other immunosuppressive therapy within 7 days before the first dose of treatment.
  • Have active Hepatitis B or C.
  • Plan to move during the study period.
  • Have acute medical conditions that would prevent participation.
  • Are using opioids within 2 weeks before joining the study, except for certain treatments for opioid or alcohol use disorder.
  • Have uncontrolled illnesses or infections that would limit study participation.
  • Are pregnant, breastfeeding, or unwilling to use contraception during the study and for 120 days after the last dose.

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