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

NCT00919997 | Completed

• 3 other identifiers: AMC-060U01CA121947CDR0000629624
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

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.

Conditions

Nonneoplastic Condition; Precancerous Condition

Keywords

human papilloma virus infection; HIV infection; HIV Infections

Outcome Measures

Primary Outcomes (1)

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

  Study entry

Secondary Outcomes (2)

• Distribution of strain variants of HPV 16, 18 and 31

  Study entry

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

  Study entry

Study Arms (1)

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; 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

Interventions

DNA analysis GENETIC

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

Specimen collection

polymerase chain reaction GENETIC

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

Specimen collection

fluorescence activated cell sorting OTHER

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

Specimen collection

questionnaire administration OTHER

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

Specimen collection

study of socioeconomic and demographic variables OTHER

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

Specimen collection

study of high risk factors PROCEDURE

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

Specimen collection

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator
• The Emmes Company, LLC: collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Anal cytology Penile cytology Saliva Blood

MeSH Terms

Conditions

Precancerous Conditions; Papillomavirus Infections; HIV Infections

Interventions

Polymerase Chain Reaction; Flow Cytometry

Condition Hierarchy (Ancestors)

Neoplasms; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acid Amplification Techniques; Genetic Techniques; Investigative Techniques; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical

Study Officials

• Joel Palefsky, MD

  University of California, San Francisco

  STUDY CHAIR

• Dilip Mathai, MD

  Christian Medical College and Hospital

  PRINCIPAL INVESTIGATOR

• Ashok Row Kavi

  Humsafar Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2009
• First Posted: June 12, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: October 5, 2015

Record last verified: 2015-10

Locations

US (1)