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Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection

This study has been completed.
Sponsor:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00513526
First received: August 6, 2007
Last updated: August 27, 2014
Last verified: August 2014

August 6, 2007
August 27, 2014
November 2007
May 2010   (final data collection date for primary outcome measure)
  • Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine [ Time Frame: All study visits ] [ Designated as safety issue: Yes ]
  • Detectable Human Papillomavirus (HPV) Antibody to Type 6 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 6 at Baseline [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Detectable Human Papillomavirus (HPV) Antibody to Type 11 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 11 at Baseline [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Detectable Human Papillomavirus (HPV) Antibody to Type 16 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 16 at Baseline [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Detectable Human Papillomavirus (HPV) Antibody to Type 18 a Month After the Completion of HPV Vaccination Series (Week 28) Among Patients Seronegative for Type 18 at Baseline [ Time Frame: Week 28 ] [ Designated as safety issue: No ]
  • Occurrence of ≥ grade 3 adverse events probably or definitely related to the vaccine
  • Detectable human papillomavirus (HPV) antibody to types 6, 11, 16 and 18, a month after the completion of HPV vaccination series (week 28) among patients seronegative for those types at baseline
Complete list of historical versions of study NCT00513526 on ClinicalTrials.gov Archive Site
  • Longitudinal Changes in CD4+ Cell Count From Baseline [ Time Frame: Week 0, 4, 12, 28 ] [ Designated as safety issue: No ]
    CD4+ cell count at week 0 was subtracted from CD4+ cell counts at each of weeks 4, 12, and 28.
  • Longitudinal Changes in Plasma HIV-1 RNA From Baseline [ Time Frame: Week 0, 4, 12, 28 ] [ Designated as safety issue: No ]
    Plasma HIV-1 RNA at week 0 was subtracted from plasma HIV-1 RNA at each of weeks 4, 12, and 28.
  • HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status [ Time Frame: weeks 0, 28, and 76 ] [ Designated as safety issue: No ]
  • HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status [ Time Frame: weeks 0, 28, and 76 ] [ Designated as safety issue: No ]
  • HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status [ Time Frame: weeks 0, 28, and 76 ] [ Designated as safety issue: No ]
  • HPV Antibody Titers to Type 18 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status [ Time Frame: weeks 0, 28, and 76 ] [ Designated as safety issue: No ]
  • Type-specific Serum IgA Levels [ Time Frame: weeks 0, 4, 12, 28, 52, and 72 ] [ Designated as safety issue: No ]
  • Longitudinal changes in plasma HIV-1 RNA and CD4+ cell count from baseline
  • HPV antibody titers to types 6, 11, 16, 18 at baseline and weeks 4, 12, 28, 52, and 72
  • Type-specific serum IgA levels
Not Provided
Not Provided
 
Human Papillomavirus Vaccine Therapy in Treating Men With HIV-1 Infection
A Single-Arm, Open-Label Pilot Trial of the Safety and Immunogenicity of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men

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.

OBJECTIVES:

Primary

  • To assess the safety and tolerability of quadrivalent human papillomavirus (HPV) (types 6, 11, 16, 18) recombinant vaccine in HIV-infected men.
  • To assess the immunogenicity of the quadrivalent HPV vaccine for types 6, 11, 16 and 18 in subjects who are antibody-negative at baseline.

Secondary

  • To evaluate the changes in plasma HIV-1 RNA and CD4+ count after the vaccination series.
  • To describe the associations of CD4+ count, nadir CD4+ count, and age on antibody response.
  • To evaluate the levels and persistence of HPV 6, 11, 16, and 18 antibody titers after the vaccination series among subjects according to serostatus at baseline.
  • To evaluate the oral levels of serum IgA before and after the vaccination series.

Tertiary

  • To evaluate prevalent and incident HPV infections in the anal canal.
  • To evaluate cytological and histological abnormalities in the anal canal.
  • To evaluate prevalent and incident HPV infections in the oral cavity.
  • To compare oral and anal compartmental shedding of HPV before and after vaccination.

OUTLINE: This is a multicenter study.

Patients receive quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine intramuscularly on day 0 and weeks 8 and 24.

After completion of protocol therapy, patients are followed at 7, 12, and 18 months.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infection
  • Precancerous Condition
Biological: Gardasil
week 0, 8, 24, 128
Other Name: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
Experimental: Gardasil
Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
Intervention: Biological: Gardasil
Wilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM, Jay N, Aboulafia D, Cohn DL, Einstein MH, Saah A, Mitsuyasu RT, Palefsky JM. Safety and immunogenicity of the quadrivalent human papillomavirus vaccine in HIV-1-infected men. J Infect Dis. 2010 Oct 15;202(8):1246-53.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
October 2011
May 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00513526
AMC-052, CDR0000559149, U01CA121947
No
AIDS Malignancy Clinical Trials Consortium
AIDS Malignancy Clinical Trials Consortium
  • National Cancer Institute (NCI)
  • The EMMES Corporation
Study Chair: Timothy J. Wilkin, MD, MPH Weill Medical College of Cornell University
Principal Investigator: Joel Palefsky, MD University of California, San Francisco
AIDS Malignancy Clinical Trials Consortium
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP