Clinical trial · Interventional
Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males
AMC-072: Protective Effect of Quadrivalent Vaccine in Young HIV-Positive Males Who Have Sex With Males
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to prevent viral infection. PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal Cancer | Malignant Anal Neoplasm | CURATED_EXACT | 0.92 |
| Nonneoplastic Condition | — | UNRESOLVED | — |
| Penile Cancer | Malignant Penile Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vaccination
- description
- Gardasil (quadrivalent HPV types 6, 11, 16, 18) vaccination at weeks 0, 8, 24.
- interventionNames
- Biological: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
- Other: laboratory biomarker analysis
Primary outcomes (16)
- measure
- Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA
- timeFrame
- Post Month 7 through Month 24
- description
- Incident events are defined as having AIN (e.g., AIN or anal/perianal condyloma) with HPV 6 positive DNA in participants without HPV-6 related AIN at baseline.
- measure
- Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA
- timeFrame
- Post Month 7 through Month 24
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 13 Years
- Maximum age
- 26 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Men with a history of at least one male sexual partner
* "Men" is defined as those documented "male" at birth (including male-to-female transgendered persons)
* HIV-1 infection as documented by any federally approved, licensed HIV test performed in conjunction with screening (ELISA, western blot, or other approved test)
* Alternatively, this documentation may include a record that another physician has documented that the patient has HIV based on prior ELISA and western blot, or other approved diagnostic tests
* Meets one of the following sets of criteria:
* Patients receiving antiretroviral therapy:
* Receipt of antiretroviral therapy for at least 3 months prior to entry
* No change in antiretroviral therapy within 30 days prior to entry
* Patients not receiving antiretroviral therapy:
* CD4-cell count ≥ 350 cells/mm³ within 90 days prior to study entry
* No plans to start antiretroviral therapy prior to Week 28
* Normal anal cytological result, LSIL/condyloma, or ASCUS result within 90 days prior to entry, and no HGAIN on biopsy
* No current or history of anal or peri-anal carcinoma
* No anal cytological result of HSIL, atypical squamous cells suggestive of HSIL (ASC-H), or suggestive of invasive carcinoma at screening; or history of these results
* No presence of penile or scrotal condyloma, LGAIN (condyloma or AIN 1), HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry on biopsy
* No history of HGAIN
PATIENT CHARACTERISTICS:
* Karnofsky performance score ≥ 70 within 45 days prior to entry
* Absolute neutrophil count (ANC) \> 750 cells/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm\^3
* AST (SGOT), ALT (SGPT) ≤ 3 times upper limit of normal (ULN)
* Total or conjugated (direct) bilirubin ≤ 2.5 times ULN within 45 days before study entry, with the exception of isolated hyperbilirubinemia that is considered due to atazanavir
* Calculated creatinine clearance ≥ 60 mL/min
* No hemophilia
* No active drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements
* No serious illness requiring systemic treatment and/or hospitalization within 45 days prior to entry
* No serious medical or psychiatric illness that, in the opinion of the site Investigator, will interfere with the ability of the subject to give informed consent or adhere to the protocol
* No allergy to yeast or any of the components of Gardasil
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* No prior splenectomy
* No prior receipt of Gardasil or other HPV vaccine
* No use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry
* No expected use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids used for greater than 14 days, investigational vaccines, interleukins, interferons, growth factors, or IVIG during study followup
* No patients with hepatitis C who expect to initiate treatment for hepatitis C (e.g., interferons) during this trial
* Not currently receiving anticoagulation therapy other than acetylsalicylic acidReferences
Publications (1)
- DERIVEDKahn JA, Belzer M, Chi X, Lee J, Gaur AH, Mayer K, Martinez J, Futterman DC, Stier EA, Paul ME, Chiao EY, Reirden D, Goldstone SE, Ortiz Martinez AP, Cachay ER, Barroso LF, Da Costa M, Wilson CM, Palefsky JM; AIDS Malignancy Consortium and Adolescent Medicine Trials Network for HIV/AIDS Interventions. Pre-vaccination prevalence of anogenital and oral human papillomavirus in young HIV-infected men who have sex with men. Papillomavirus Res. 2019 Jun;7:52-61. doi: 10.1016/j.pvr.2019.01.002. Epub 2019 Jan 15. PMID 30658128