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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier:
NCT00919997
First received: June 11, 2009
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: HPV Infection in Indian HIV-Seropositive Men Who Have Sex With Men (MSM)

Resource links provided by NLM:


Further study details as provided by AIDS Malignancy Clinical Trials Consortium:

Primary Outcome Measures:
  • Detectable human papilloma virus DNA in the penis, anus, or mouth [ Time Frame: Study entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Distribution of strain variants of HPV 16, 18 and 31 [ Time Frame: Study entry ] [ Designated as safety issue: No ]
  • Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM [ Time Frame: Study entry ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Anal cytology Penile cytology Saliva Blood


Enrollment: 302
Study Start Date: July 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919997

Locations
United States, California
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
AIDS Malignancy Clinical Trials Consortium
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

Additional Information:
No publications provided

Responsible Party: AIDS Malignancy Clinical Trials Consortium
ClinicalTrials.gov Identifier: NCT00919997     History of Changes
Other Study ID Numbers: CDR0000629624, U01CA121947, AMC-060
Study First Received: June 11, 2009
Last Updated: November 2, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board
India: Indian Council of Medical Research
India: Institutional Review Board

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

Additional relevant MeSH terms:
Precancerous Conditions
Virus Diseases
Warts
Papillomavirus Infections
Neoplasms
DNA Virus Infections
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on April 23, 2014