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

NCT00513526 | Completed Phase 2 Results

• 3 other identifiers: AMC-052CDR0000559149U01CA121947
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Infection; Precancerous Condition

Keywords

infection; low-grade squamous intraepithelial lesion; atypical squamous cells of undetermined significance

Outcome Measures

Primary Outcomes (5)

• Occurrence of ≥ Grade 3 Adverse Events Probably or Definitely Related to the Vaccine

  Occurrence of grade 3+ adverse events that are at least probably and definitely related to the vaccine

  All study visits

• 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

  Week 28

• 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

  Week 28

• 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

  Week 28

• 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

  Week 28

Secondary Outcomes (7)

• Longitudinal Changes in CD4+ Cell Count From Baseline

  Week 0, 4, 12, 28

• Longitudinal Changes in Plasma HIV-1 RNA From Baseline

  Week 0, 4, 12, 28

• HPV Antibody Titers to Type 6 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status

  weeks 0, 28, and 76

• HPV Antibody Titers to Type 11 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status

  weeks 0, 28, and 76

• HPV Antibody Titers to Type 16 at Baseline and Weeks 28 and 76 According to Baseline Seropositive Status

  weeks 0, 28, and 76

Study Arms (1)

Gardasil

EXPERIMENTAL

Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.

Biological: Gardasil

Interventions

Gardasil BIOLOGICAL

week 0, 8, 24, 128

Also known as: quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Gardasil

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• The Emmes Company, LLC: collaborator

Study Sites (8)

UCLA Clinical AIDS Research and Education (CARE) Center

Los Angeles, California, 90095-1793, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204-4507, United States

Location

Boston University Cancer Research Center

Boston, Massachusetts, 02118, United States

Location

Laser Surgery Care

New York, New York, 10010, United States

Location

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Benaroya Research Institute at Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Related Publications (2)

• Kang M, Umbleja T, Ellsworth G, Aberg J, Wilkin T. Effects of Sex, Existing Antibodies, and HIV-1-Related and Other Baseline Factors on Antibody Responses to Quadrivalent HPV Vaccine in Persons With HIV. J Acquir Immune Defic Syndr. 2022 Apr 1;89(4):414-422. doi: 10.1097/QAI.0000000000002891.

  PMID: 34907980 DERIVED

• 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. doi: 10.1086/656320.

  PMID: 20812850 DERIVED

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Infections; Precancerous Conditions; Squamous Intraepithelial Lesions; Atypical Squamous Cells of the Cervix

Interventions

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Condition Hierarchy (Ancestors)

Neoplasms; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms; Uterine Cervical Dysplasia; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Combined; Vaccines; Biological Products; Complex Mixtures; Papillomavirus Vaccines; Viral Vaccines

Results Point of Contact

• Title: Group Statistician
• Organization: AMC

jylee@uams.edu

501-526-6712

Study Officials

• Timothy J. Wilkin, MD, MPH

  Weill Medical College of Cornell University

  STUDY CHAIR

• Joel Palefsky, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2007
• First Posted: August 8, 2007
• Study Start: November 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: October 1, 2011
• Last Updated: November 14, 2023
• Results First Posted: July 26, 2011

Record last verified: 2023-10

Locations

US (8)