Impact of a Human Papilloma Virus (HPV) Vaccine in HIV-Infected Young Women
Condition: HIV Infection
MeSH terms: HIV Infections
Intervention: HPV vaccine for strains -6, -11, -16, and -18
Intervention description: All subjects will receive three doses of the HPV-6, -11, -16, -18 vaccine at the recommended dose and schedule (Day 0, Week 8, and Week 24).
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: Female
Minimum age: 16 Years
Maximum age: 23 Years
Healthy volunteers: No
Keywords: Highly-active antiretroviral therapy; Human papillomavirus; HPV vaccine

Summary:

      The purpose of this study is to evaluate the immunogenicity, safety, tolerability, and
      behavioral impact of an HPV-6, -11, -16, -18 vaccine in HIV-infected young women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Young women age 16 years and 0 days to 23 years and 364 days

          -  HIV-infection after the age of 9 years as documented by a positive result on any of
             the following licensed tests: any antibody test confirmed by Western blot, HIV-1
             culture, HIV-1 DNA polymerase chain reaction (PCR), or plasma HIV-1 RNA > 1,000
             copies/ml

          -  HIV treatment history that falls in one of the following categories:

        Group A: ART naïve or if ART-exposed, has not received HAART for at least the six months
        prior to study entry Group B: Has been receiving HAART for at least six months at the time
        of study entry, with two HIV-1 RNA plasma viral loads < 400 copies/ml on two previous
        clinical visits within the 6 months prior to study entry

          -  Willingness to avoid pregnancy from study entry through the Week 28 visit for subjects
             of child-bearing potential, i.e., use of at least one barrier or hormonal method;
             e.g., condoms, Depo-Provera, oral contraceptive pills, etc. Subjects on antiretroviral
             (ARV) medications must use a barrier contraceptive method because ARV medications can
             make hormonal birth control less effective.

          -  Anticipated ability and willingness to complete all study vaccines and evaluations

          -  Ability and willingness to participate in the study by providing written informed
             consent

        Exclusion Criteria:

          -  History of any prior vaccination with an HPV vaccine

          -  Active anogenital warts within three months prior to study entry) or history of
             cervical intraepithelial neoplasia (CIN) 2/3 (ever, must be documented by colposcopy)

          -  Previous allergic reaction to any constituents of the HPV vaccine

          -  Pregnancy

          -  Active substance use or dependence that, in the opinion of the site personnel, would
             interfere with adherence to the study

          -  Active opportunistic infection or current treatment for known or suspected active
             serious bacterial infection at the time of study entry

          -  Presence of any known > Grade 3 clinical or laboratory toxicity at the time of study
             entry (per the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN)
             Toxicity Tables, see ATN MOGO) with the exception of isolated Grade 3 serum total
             hyperbilirubinemia that is considered due to atazanavir (see Section 9.6 for
             definition of isolated total hyperbilirubinemia).

          -  Receipt of any routine vaccine within four weeks prior to study entry

          -  Receipt of any immune globulin or plasma product within six months prior study entry

          -  Receipt of any blood product or transfusion, other than immune globulin or plasma as
             noted above, within four weeks prior to study entry

          -  Receipt of any restricted medication listed in Section 5.3.2 within the four weeks
             preceding study entry

          -  Receipt of any other disallowed medication listed in Section 5.3.3 within the three
             months preceding study entry

          -  Thrombocytopenia or coagulation disorder that would contraindicate intramuscular
             injection

          -  Anticipation of long-term systemic corticosteroid therapy (more than 10 mg/day of
             prednisone or equivalent for > 2 consecutive weeks)

          -  Receipt of corticosteroid therapy at the above dose and duration within 3 months
             preceding study entry. Use of non-steroidal anti-inflammatory agents and inhaled or
             topical corticosteroids are not exclusion criteria

          -  Known or suspected disease of the immune system (other than HIV), i.e., malignancy,
             current or prior treatment for malignancy

          -  If other serious, acute or chronic medical or surgical conditions or contraindications
             are present during screening, the Protocol Team must be consulted to determine whether
             enrollment may interfere with the evaluation of the protocol objectives and for
             permission to proceed with the enrollment