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

• Sponsor: AIDS Malignancy Consortium (Other)
• Overall Status: Completed
• CT.gov ID: NCT00919997
• Collaborator: National Cancer Institute (NCI) (NIH), The Emmes Company, LLC (Industry)
• Enrollment: 302
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 25.2

Study Details

Study Description

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	Phase
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

• 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: Jul 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Jul 1, 2010

Arms and Interventions

Arm

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

Primary Outcome Measures

1. Detectable human papilloma virus DNA in the penis, anus, or mouth [Study entry]

Secondary Outcome Measures

1. Distribution of strain variants of HPV 16, 18 and 31 [Study entry]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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 Company, LLC

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AIDS Malignancy Consortium
• ClinicalTrials.gov Identifier: NCT00919997
• Other Study ID Numbers: AMC-060; U01CA121947; CDR0000629624
• First Posted: Jun 12, 2009
• Last Update Posted: Oct 5, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by AIDS Malignancy Consortium: human papilloma virus infection; HIV infection; HIV Infections
• Additional relevant MeSH terms: Infections; Papillomavirus Infections; Precancerous Conditions; Disease

Study Results

No Results Posted as of Oct 5, 2015