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

N/ACompletedNCT00919997

AIDS Malignancy Consortium302 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

302

Conditions

Nonneoplastic Condition Precancerous Condition

Interventions

DNA analysisGENETIC

Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.

polymerase chain reactionGENETIC

Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.

fluorescence activated cell sortingOTHER

Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Outcomes

Primary Outcomes

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

Time frame: Study entry

Secondary Outcomes

Distribution of strain variants of HPV 16, 18 and 31

Time frame: Study entry

Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM

Time frame: Study entry

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.