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HPV Infection in Indian HIV-Seropositive Men Who Have Sex With Men (MSM)

18 Years
Not Enrolling
Nonneoplastic Condition, Precancerous Condition

Thank you

Trial Information

HPV Infection in Indian HIV-Seropositive Men Who Have Sex With Men (MSM)


- Describe the prevalence of penile, anal, and oral human papilloma virus (HPV) infection
in HIV-seropositive Indian men who have sex with men.

- Determine the spectrum of HPV types at these anatomic sites in these patients.

- Determine the distribution of strain variants of HPV 16, 18, and 31 at these anatomic
sites in these patients.

- Describe risk factors for penile, anal, and oral HPV infection in these patients.

OUTLINE: This is a multicenter study.

Patients complete interviewer-administered questionnaires on demographics, native place,
socioeconomic status, medical history, numbers of sexual partners and sexual practices,
circumcision status, and risk factors for oral malignancies and human papilloma virus (HPV),
including oral sex, smoking or chewing tobacco, drug use, oral hygiene, and tooth loss.

Patients undergo cell sample collection from the penis, scrotum, anus, and mouth, and saliva
sample collection for HPV DNA testing by PCR. Patients also undergo blood sample collection
to measure CD4+ count and HIV viral load by FACS and PCR.

Inclusion Criteria


- HIV-1 infection, as documented by ELISA and confirmed by a second testing method
(e.g., western blot, HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second
antibody test by a method other than ELISA)

- If prior documentation and confirmation of HIV-1 infection is not available, two
licensed rapid HIV tests are allowed

- Must have had receptive or insertive anal intercourse with another man within the
past 6 months


- Speaks Hindi (in Mumbai) or Tamil (in Vellore)

- No active drug or alcohol use or dependence that, in the opinion of the site
Investigator, would interfere with adherence to study requirements

- No history of a sex-change operation that would preclude collection of penile or
scrotal specimens


- Not specified

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Detectable human papilloma virus DNA in the penis, anus, or mouth

Outcome Time Frame:

Study entry

Safety Issue:


Principal Investigator

Joel Palefsky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of California, San Francisco


United States: Federal Government

Study ID:




Start Date:

July 2009

Completion Date:

July 2010

Related Keywords:

  • Nonneoplastic Condition
  • Precancerous Condition
  • human papilloma virus infection
  • HIV infection
  • HIV Infections
  • Precancerous Conditions
  • Virus Diseases
  • Warts
  • Papillomavirus Infections



UCSF Helen Diller Family Comprehensive Cancer CenterSan Francisco, California  94115