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

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ClinicalTrials.gov Identifier: NCT00919997
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : October 5, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment
Nonneoplastic Condition Precancerous Condition Genetic: DNA analysis Genetic: polymerase chain reaction Other: fluorescence activated cell sorting Other: questionnaire administration Other: study of socioeconomic and demographic variables Procedure: study of high risk factors

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.


Study Design
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Study Type : Observational
Actual Enrollment : 302 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: HPV Infection in Indian HIV-Seropositive Men Who Have Sex With Men (MSM)
Study Start Date : July 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Specimen collection
Single group study. Blood, saliva, anal cytology, and penile cytology samples, and questionnaire responses will be collected from participants at a single study visit.
 Genetic: DNA analysis
Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.
Genetic: polymerase chain reaction
Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
Other: fluorescence activated cell sorting
Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
Other: questionnaire administration
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
Other: study of socioeconomic and demographic variables
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
Procedure: study of high risk factors
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Detectable human papilloma virus DNA in the penis, anus, or mouth [ Time Frame: Study entry ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Anal cytology Penile cytology Saliva Blood

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919997


Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
The EMMES Corporation
Investigators
Study Chair: Joel Palefsky, MD University of California, San Francisco
Principal Investigator: Dilip Mathai, MD Christian Medical College and Hospital
Principal Investigator: Ashok Row Kavi Humsafar Trust
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: AIDS Malignancy Consortium
ClinicalTrials.gov Identifier: NCT00919997     History of Changes
Other Study ID Numbers: AMC-060
U01CA121947 ( U.S. NIH Grant/Contract )
CDR0000629624 ( Other Identifier: NCI )
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: October 2015

Keywords provided by AIDS Malignancy Consortium:
human papilloma virus infection
HIV infection
HIV Infections

Additional relevant MeSH terms:
Infection
Disease
Precancerous Conditions
Papillomavirus Infections
Pathologic Processes
 Neoplasms
DNA Virus Infections
Virus Diseases
Tumor Virus Infections