Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients … (NCT01209325) | Clinical Trial Compass
CompletedPhase 2
Vaccine Therapy in Preventing Human Papillomavirus Infection in Young HIV-Positive Male Patients Who Have Sex With Males
United States149 participantsStarted 2011-06-28
Plain-language summary
RATIONALE: Vaccines made from a gene-modified virus may help the body build an effective immune response to prevent viral infection.
PURPOSE: This phase II trial is studying how well vaccine therapy works in preventing human papillomavirus (HPV) infection in young HIV-positive male patients who have sex with males.
Who can participate
Age range13 Years – 26 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Men with a history of at least one male sexual partner
* "Men" is defined as those documented "male" at birth (including male-to-female transgendered persons)
* HIV-1 infection as documented by any federally approved, licensed HIV test performed in conjunction with screening (ELISA, western blot, or other approved test)
* Alternatively, this documentation may include a record that another physician has documented that the patient has HIV based on prior ELISA and western blot, or other approved diagnostic tests
* Meets one of the following sets of criteria:
* Patients receiving antiretroviral therapy:
* Receipt of antiretroviral therapy for at least 3 months prior to entry
* No change in antiretroviral therapy within 30 days prior to entry
* Patients 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, LSIL/condyloma, or ASCUS result within 90 days prior to entry, and no HGAIN on biopsy
* No current or history of anal or peri-anal carcinoma
* No anal cytological result of HSIL, atypical squamous cells suggestive of HSIL (ASC-H), or suggestive of invasive carcinoma at screening; or history of these results
* No presence of penile or scrotal condyloma, LGAIN (condyloma or AIN 1), HGAIN (e.g., AIN 2 or 3, or perianal intraepithelial neoplasia grade 2 or 3), or invasive carc…
What they're measuring
1
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 6 DNA
Timeframe: Post Month 7 through Month 24
2
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 11 DNA
Timeframe: Post Month 7 through Month 24
3
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 16 DNA
Timeframe: Post Month 7 through Month 24
4
Incidence of AIN or Anal/Perianal Condyloma Associated With HPV 18 DNA
Timeframe: Post Month 7 through Month 24
5
Incidence of Persistent Anogenital Infection With HPV 6 DNA
Timeframe: Post Month 7 through Month 24
6
Incidence of Persistent Anogenital Infection With HPV 11 DNA
Timeframe: Post Month 7 through Month 24
7
Incidence of Persistent Anogenital Infection With HPV 16 DNA
Timeframe: Post Month 7 through Month 24
8
Incidence of Persistent Anogenital Infection With HPV 18 DNA