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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA121947 | U.S. NIH Grant/Contract | View source | |
| CDR0000629624 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| The Emmes Company, LLC | INDUSTRY |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNA analysis | Genetic | Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Detectable human papilloma virus DNA in the penis, anus, or mouth | Study entry |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
PRIOR CONCURRENT THERAPY:
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HIV-1 infected men who have sex with men from Mumbai and Vellore, India, who are age 18 or older.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94115 | United States |
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Anal cytology Penile cytology Saliva Blood
| polymerase chain reaction | Genetic | Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA. |
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| fluorescence activated cell sorting | Other | Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA. |
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| questionnaire administration | Other | Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM. |
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| study of socioeconomic and demographic variables | Other | Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM. |
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| study of high risk factors | Procedure | Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM. |
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| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D030361 | Papillomavirus Infections |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D016133 | Polymerase Chain Reaction |
| D005434 | Flow Cytometry |
| ID | Term |
|---|---|
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
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