Clinical trial NCT00919997: Human Papilloma Virus Infection in HIV-Positive Indian Men Who Have Sex With Men
Official title: HPV Infection in Indian HIV-Seropositive Men Who Have Sex With Men (MSM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nonneoplastic Condition
Precancerous Condition
Keywords: human papilloma virus infection
HIV infection
HIV Infections
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: The Emmes Company, LLC
First posted: 2009-06-12
Enrollment: 302
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-1 infected men who have sex with men from Mumbai and Vellore, India, who are age 18 or older.

Brief summary: RATIONALE: Gathering information about human papilloma virus (HPV) infection in HIV-positive men who have sex with men may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying HPV infection in HIV-positive Indian men who have sex with men.

Detailed description: OBJECTIVES:

* 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* 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

PATIENT CHARACTERISTICS:

* 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

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Detectable human papilloma virus DNA in the penis, anus, or mouth
timeFrame: Study entry
Secondary outcomes:
measure: Distribution of strain variants of HPV 16, 18 and 31
timeFrame: Study entry
measure: Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM
timeFrame: Study entry
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Joel Palefsky, MD
role: STUDY_CHAIR
affiliation: Christian Medical College and Hospital
name: Dilip Mathai, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Humsafar Trust
name: Ashok Row Kavi
role: PRINCIPAL_INVESTIGATOR
References: