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

Precancerous Condition Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease
• Nonneoplastic Condition
• Papillomavirus Infections
• Precancerous Condition
• Precancerous Conditions

• NCT number: NCT00919997
• Study type: Observational
• Source: AIDS Malignancy Consortium
• Status: Completed
• Phase: N/A
• Start date: July 2009
• Completion date: July 2010