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Completed

NCT Number: NCT00919997

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DNA analysis

Genetic

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

polymerase chain reaction

Genetic

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

fluorescence activated cell sorting

Other

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

Questionnaire Administration

Other

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

study of socioeconomic and demographic variables

Other

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

study of high risk factors

Procedure

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

Primary outcomes

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

    Time frame: Study entry

Secondary outcomes

  1. Distribution of strain variants of HPV 16, 18 and 31

    Time frame: Study entry

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

    Time frame: Study entry

Sponsors and collaborators

Lead sponsor

AIDS Malignancy Consortium

Network

Collaborators

  • National Cancer Institute (NCI)
  • The Emmes Company, LLC

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 12, 2009
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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