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Human Papilloma Virus Infection in HIV-Positive Indian Men Who Have Sex With Men
This study has been completed.
Sponsor:
AIDS Malignancy Consortium
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:
NCT00919997
First received: June 11, 2009
Last updated: October 1, 2015
Last verified: October 2015
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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 Consortium:
Primary Outcome Measures:
- Detectable human papilloma virus DNA in the penis, anus, or mouth [ Time Frame: Study entry ]
Secondary Outcome Measures:
- 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
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 (Adult, Senior) |
| Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919997
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 Consortium
National Cancer Institute (NCI)
The EMMES Corporation
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
| Responsible Party: | AIDS Malignancy Consortium |
| ClinicalTrials.gov Identifier: | NCT00919997 History of Changes |
| Other Study ID Numbers: |
AMC-060 U01CA121947 ( US NIH Grant/Contract Award Number ) CDR0000629624 ( Other Identifier: NCI ) |
| Study First Received: | June 11, 2009 |
| Last Updated: | October 1, 2015 |
Keywords provided by AIDS Malignancy Consortium:
|
human papilloma virus infection HIV infection HIV Infections |
Additional relevant MeSH terms:
|
Infection Disease Precancerous Conditions Papillomavirus Infections Pathologic Processes |
Neoplasms DNA Virus Infections Virus Diseases Tumor Virus Infections |
ClinicalTrials.gov processed this record on June 23, 2017