Trial Search Results

Quadrivalent HPV Vaccine to Prevent Anal HPV in HIV-infected Men and Women

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Stanford Investigator(s):

Intervention(s):

  • Biological: Quadrivalent HPV Vaccine
  • Biological: Placebo Vaccine for Male Participants Only
  • Biological: Placebo Vaccine for Female Participants Only

Phase:

Phase 3

Eligibility


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

Ages Eligible for Study

27 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Debbie Slamowitz, RN
650-723-2804
Not Recruiting