Human Papilloma Virus Infection in HIV-Positive Indian Men Who Have Sex With Men

AIDS Malignancy Consortium

Status: Completed

Conditions: Nonneoplastic Condition; Precancerous Condition

Treatments: Other: study of socioeconomic and demographic variables; Other: questionnaire administration; Genetic: polymerase chain reaction; Procedure: study of high risk factors; Genetic: DNA analysis; Other: fluorescence activated cell sorting

Study type: Observational

Funder types: NETWORK; Industry; NIH

Identifiers

NCT00919997

U01CA121947 (U.S. NIH Grant/Contract)

CDR0000629624 (Other Identifier)

AMC-060

Details and patient eligibility

About

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.

Full 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.

Enrollment: 302 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

302 participants in 1 patient group

Specimen collection

Description:

Single group study. Blood, saliva, anal cytology, and penile cytology samples, and questionnaire responses will be collected from participants at a single study visit.

Treatment:

Other: study of socioeconomic and demographic variables

Other: questionnaire administration

Genetic: DNA analysis

Other: fluorescence activated cell sorting

Procedure: study of high risk factors

Genetic: polymerase chain reaction