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

Completed · Phase 2

Conditions studied: Infection, Precancerous Condition

In brief

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.

Key facts

Study ID

NCT00513526

Run by

AIDS Malignancy Consortium

People needed

112

Starts

2007-11-01

Expected to finish

2011-10-01

Last updated by the study team

2023-11-14

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

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:
• 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

Where it is running

• UCLA Clinical AIDS Research and Education (CARE) Center — Los Angeles, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Boston University Cancer Research Center — Boston, Massachusetts, United States
• Laser Surgery Care — New York, New York, United States
• New York Weill Cornell Cancer Center at Cornell University — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Benaroya Research Institute at Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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