Quadrivalent HPV Vaccine to Prevent Anal HPV in HIV-infected Men and Women
Condition: HIV Infections
MeSH terms: Infections
Intervention: Quadrivalent HPV Vaccine; Placebo Vaccine for Male Participants Only; Placebo Vaccine for Female Participants Only
Intervention description: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.; Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.; Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 575.0
Sex: All
Minimum age: 27 Years
Healthy volunteers: No

Summary:

      Men who have sex with men (MSM) have an increased risk of developing anal human
      papillomavirus (HPV) infections, which can be a risk factor for anal cancer. HIV-infected
      women are also at risk of anal cancer. This study will evaluate the effectiveness of the Food
      and Drug Administration (FDA)-approved quadrivalent HPV vaccine, Gardasil, at preventing anal
      HPV infection in HIV-infected MSM and HIV-infected women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or
             chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and
             confirmed by a licensed Western blot or a second antibody test by a method other than
             the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load.
             More information on this criterion can be found in the protocol.

          -  Laboratory values obtained within 45 days prior to entry by any U.S. laboratory that
             has a Clinical Laboratory Improvement Amendment (CLIA) certification or its
             equivalent, or at any network-approved non-U.S. laboratory that operates in accordance
             with Good Clinical Practices and participates in appropriate external quality
             assurance programs:

               1. Absolute neutrophil count (ANC) greater than 750 cells/mm^3

               2. Hemoglobin greater than or equal to 9.0 g/dL

               3. Platelet count greater than or equal to 75,000/mm^3

               4. Serum creatinine less than or equal to three times the upper limit of normal
                  (ULN)

               5. Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])
                  and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT])
                  less than or equal to five times the ULN

               6. Total or conjugated (direct) bilirubin less than or equal to 2.5 times the ULN

          -  For men, receptive anal sex (defined as receptive penile-anal sex or receptive
             oral-anal sex with another man) within 1 year prior to entry

          -  Anal cytology result from specimen obtained within 45 days prior to entry

          -  HRA performed within 45 days prior to entry by a certified HRA provider with no
             evidence of invasive or microinvasive anal cancer by anal biopsy or by visual
             inspection if no biopsy was obtained. Note: refer to protocol for more information
             about HRA certification process.

          -  For women, gynecologic examination (including screening for cervical disease by
             exfoliative cytology with or without colposcopy) within 45 days prior to entry.

          -  For women of reproductive potential, a negative serum or urine pregnancy test within
             45 days prior to study entry by any U.S. laboratory that has a CLIA certification or
             its equivalent, or at any network-approved non-U.S. laboratory that operates in
             accordance with Good Clinical Practices and participates in appropriate external
             quality assurance programs. More information on this criterion can be found in the
             protocol.

          -  Confirmation of the availability of the anal swab, vaginal swab (women only) and Scope
             oral rinse specimens for HPV DNA PCR obtained at screening. The site must confirm that
             these samples have been entered into the Laboratory Data Management System (LDMS).

          -  Ability and willingness of participant or legal representative to provide informed
             consent

        Exclusion Criteria:

          -  History or current biopsy diagnosis of invasive or microinvasive cancer, i.e.:

               -  For all participants: anal or oropharyngeal cancer

               -  For men: penile cancer

               -  For women: cervical, vulvar, or vaginal cancer

               -  More information on this criterion can be found in the protocol.

          -  Anal, cervical, or vaginal cytological results suspicious for invasive carcinoma at
             any point prior to entry

          -  Topical or surgical treatment for intra- or perianal intraepithelial neoplasia or
             condyloma within 6 months prior to entry. More information on this criterion can be
             found in the protocol.

          -  Prior receipt of one or more doses of an HPV vaccine

          -  Receipt of anticoagulants other than aspirin or nonsteroidal anti-inflammatory drugs
             (NSAIDS) within 14 days prior to entry

          -  Known allergy/sensitivity or any hypersensitivity to yeast or any of the components of
             the study product or its formulation. More information on this criterion can be found
             in the protocol.

          -  Active drug or alcohol use or dependence or other condition that, in the opinion of
             the site investigator, would interfere with adherence to study requirements

          -  Serious illness requiring systemic treatment and/or hospitalization within 21 days
             prior to entry

          -  Hemophilia or other bleeding diatheses

          -  Use of any systemic antineoplastic or immunomodulatory treatment, systemic
             corticosteroids other than inhaled corticosteroids or prednisone less than or equal to
             10 mg (or equivalent), investigational vaccines, interleukins, interferons, growth
             factors, or intravenous immunoglobulin (IVIG) within 45 days prior to study entry.
             NOTE: Routine standard-of-care vaccines (including hepatitis A, hepatitis B,
             influenza, pneumococcal, and tetanus vaccines) are not exclusionary.

          -  Expected treatment of hepatitis B or hepatitis C virus with immunomodulatory agents in
             the 7 months after entry

          -  Breastfeeding