Human Papilloma Virus Infection in HIV-Positive Indian Men Who Have Sex With Men
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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) |
- Detectable human papilloma virus DNA in the penis, anus, or mouth [ Time Frame: Study entry ] [ Designated as safety issue: No ]
- Distribution of strain variants of HPV 16, 18 and 31 [ Time Frame: Study entry ] [ Designated as safety issue: No ]
- Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM [ Time Frame: Study entry ] [ Designated as safety issue: No ]
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 |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | AIDS Malignancy Clinical Trials Consortium |
| ClinicalTrials.gov Identifier: | NCT00919997 History of Changes |
| Other Study ID Numbers: | CDR0000629624, U01CA121947, AMC-060 |
| Study First Received: | June 11, 2009 |
| Last Updated: | November 2, 2011 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board India: Indian Council of Medical Research India: Institutional Review Board |
Keywords provided by AIDS Malignancy Clinical Trials Consortium:
|
human papilloma virus infection HIV infection HIV Infections |
Additional relevant MeSH terms:
|
Precancerous Conditions Virus Diseases Warts Papillomavirus Infections Neoplasms |
DNA Virus Infections Skin Diseases, Viral Tumor Virus Infections Skin Diseases, Infectious Skin Diseases |
ClinicalTrials.gov processed this record on February 26, 2013
