NCT04255849Active, not recruitingPhase 3
Nine-valent HPV Vaccine to Prevent Persistent Oral HPV Infection in Men Living With HIV
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
This is a randomized, double-blinded, placebo-controlled Phase III interventional trial of the nine-valent HPV vaccine (9vHPV) to prevent persistent oral HPV infection in adult men living with HIV.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 700 (estimated)
- First submitted
- 31 Jan 2020
- Start date
- 23 Feb 2021
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Weill Medical College of Cornell University
- Diseases
- HIV
- NCT number
- NCT04255849
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 700
- From 23 Feb 2021 to the primary completion date, 31 Dec 2026
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have received any doses of a licensed or experimental HPV vaccine or have participated in an HPV vaccine study,
- Have received any blood products within six months of enrollment, or are currently taking immune-suppressants.
- Have AIDS-defining condition within 6 months prior to study entry.
Other illness
- Have a history of oropharyngeal cancer (OPC) or other HPV-related cancer or have suspected OPC or other HPV-related cancer;
- Have a history of anaphylaxis to vaccines or are allergic to any vaccine component (e.g.aluminum, yeast, benzonase);
Other
- Currently have warts/lesions in the oral cavity.
- Plan to relocate during the study period.
Who the study is looking for
- HIV-1 infection
- Receipt of antiretroviral therapy for at least 6 months
- Sexually active in the past 6 months; sexual activity is defined as insertive penile-vaginal sex, receptive or insertive penile-anal sex, oral-anal sex, or oral-genital sex Willingness to comply with three-dose vaccine schedule and subsequent six-month visits for up to four years after randomization.
Age in the registry: 20 years to 50 years · Sex: Male · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidade de Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto Nacional de Salud Pública, Mexico Coordinator of this site? Confirm its status | Cuernavaca | Mexico | Unknown status |
| University of Puerto Rico AIDS Clinical Trials Unit Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.