A Single-Arm, Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men

AMC-052

RATIONALE: Vaccines made from human papillomavirus may help the body build an effective immune response to kill HIV cells. PURPOSE: This phase II trial is studying the side effects and how well human papillomavirus vaccine therapy works in treating men with HIV-1 infection.

2007-11-01

2010-05-01

2011-10-01

Completed

Early phase I

112

DISEASE CHARACTERISTICS: Inclusion criteria: * HIV-1 infection, as documented by any licensed ELISA test kit and confirmed by western blot prior to study entry * HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test * Anal human papilloma virus DNA PCR-negative for either type 16 and/or type 18 within 90 days prior to entry * If receiving antiretroviral therapy: * Receipt of antiretroviral therapy for at least 6 months prior to entry * No change in antiretroviral therapy within 30 days prior to entry * CD4 cell count \> 200 cells/mm³ within 90 days prior to study entry * HIV-1 RNA \< 200 copies/mL within 90 days prior to entry * If 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, or atypical squamous cell of undetermined significance or low-grade squamous intraepithelial lesions (SIL) result within 90 days prior to entry Exclusion criteria: * Current or history of anal or perianal carcinoma * Anal cytological result of high-grade SIL (HSIL), atypical squamous cells suggestive of HSIL, or suggestive of invasive carcinoma at screening or a history of these results * Presence of high-grade anal intraepithelial neoplasm (HGAIN) (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carcinoma at pre-entry, or history of HGAIN * Current or history of anal or peri-anal condyloma is allowed PATIENT CHARACTERISTICS: Inclusion criteria: * Karnofsky performance status 70-100% * Absolute neutrophil count \> 750 cells/mm³ * Hemoglobin ≥ 9.0 g/dL * Platelet count ≥ 100,000/mm³ * Creatinine clearance ≥ 60 mL/min * AST and ALT ≤ 3 times ULN * Total or conjugated (direct) bilirubin ≤ 2.5 times ULN Exclusion criteria: * Serious medical or psychiatric illness, active drug or alcohol use, or dependence that, in the opinion of the site Investigator, would interfere with adherence to study requirements * Serious illness requiring systemic treatment and/or hospitalization within the past 45 days * Allergy to yeast or any of the components of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine * Hemophilia PRIOR CONCURRENT THERAPY: Inclusion criteria: * See Disease Characteristics Exclusion criteria: * Prior splenectomy * Currently receiving anticoagulation therapy other than acetylsalicylic acid * Use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids, investigational vaccines, interleukins, interferons, growth factors, or IVIG within 45 days prior to study entry * Routine standard of care, including hepatitis A or B, influenza, or pneumococcal and tetanus vaccines are not excluded * Hepatitis C co-infected patients are eligible provided no concurrent initiation of treatment for hepatitis C * Prior receipt of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine or other HPV vaccine

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 112, 'type': 'ACTUAL'}}

2023-11-14