Human Papilloma Virus Infection in HIV-Positive Indian Men Who Have Sex With Men
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00919997|
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : October 5, 2015
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|
- 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 Type :||Observational|
|Actual Enrollment :||302 participants|
|Official Title:||HPV Infection in Indian HIV-Seropositive Men Who Have Sex With Men (MSM)|
|Study Start Date :||July 2009|
|Primary Completion Date :||July 2010|
|Study Completion Date :||July 2010|
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.
- Detectable human papilloma virus DNA in the penis, anus, or mouth [ Time Frame: Study entry ]
- Distribution of strain variants of HPV 16, 18 and 31 [ Time Frame: Study entry ]
- Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM [ Time Frame: Study entry ]
Biospecimen Retention: Samples With DNA
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
|United States, California|
|UCSF Helen Diller Family Comprehensive Cancer Center|
|San Francisco, California, United States, 94115|
|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|