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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919997
• Other study ID #: AMC-060
• Secondary ID: U01CA121947CDR00
• Status: Completed
• Phase: N/A
• First received: June 11, 2009
• Last updated: October 1, 2015
• Start date: July 2009
• Est. completion date: July 2010

Study information

• Verified date: October 2015
• Source: AIDS Malignancy Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardIndia: Indian Council of Medical ResearchIndia: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Genetic:
• DNA analysis
Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.
• 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.
• questionnaire administration
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
• 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.

Locations

Country	Name	City	State
United States	UCSF Helen Diller Family Comprehensive Cancer Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
AIDS Malignancy Consortium	National Cancer Institute (NCI), The EMMES Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detectable human papilloma virus DNA in the penis, anus, or mouth		Study entry	No
Secondary	Distribution of strain variants of HPV 16, 18 and 31		Study entry	No
Secondary	Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM		Study entry	No