Nonneoplastic ConditionNCT00919997
Human Papilloma Virus Infection in HIV-Positive Indian Men Who Have Sex With Men
An observational study of Nonneoplastic Condition and Precancerous Condition, run by AIDS Malignancy Consortium at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Nonneoplastic Condition, Precancerous Condition
- What is being tested?
- DNA analysis, polymerase chain reaction and fluorescence activated cell sorting
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94115
About this study
Official title: HPV Infection in Indian HIV-Seropositive Men Who Have Sex With Men (MSM)
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.
Read the 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.
- Conditions
- Nonneoplastic Condition, Precancerous Condition
- Being tested
- DNA analysis, polymerase chain reaction, fluorescence activated cell sorting, questionnaire administration, study of socioeconomic and demographic variables
- Keywords
- human papilloma virus infection, HIV infection, HIV Infections
- Medical subject headings
- Precancerous Conditions, Papillomavirus Infections, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
Anal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis.
polymerase chain reactionGenetic
Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
fluorescence activated cell sortingOther
Blood and saliva samples collected at a single study visit will be analyzed for for HPV DNA.
questionnaire administrationOther
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
study of socioeconomic and demographic variablesOther
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
study of high risk factorsProcedure or surgery
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detectable human papilloma virus DNA in the penis, anus, or mouth
Measured: Study entry
Secondary outcomes (2)
Distribution of strain variants of HPV 16, 18 and 31
Measured: Study entry
Describe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM
Measured: Study entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonneoplastic ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Joel Palefsky, MD, Study chair, University of California, San FranciscoDilip Mathai, MD, Principal investigator, Christian Medical College and HospitalAshok Row Kavi, Principal investigator, Humsafar Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919997
- Sponsor's protocol ID
- AMC-060
- Other IDs
- U01CA121947, CDR0000629624
- Status last verified
- Oct 2015
- First submitted
- 11 Jun 2009
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Infection in Indian HIV-Seropositive Men Who Have Sex With Men (MSM)
- ClinicalTrials.gov ID
- NCT00919997
- Acronym / sponsor ID
- AMC-060
- Conditions
- Nonneoplastic Condition, Precancerous Condition
- Keywords
- human papilloma virus infection, HIV infection, HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specimen collection | – | 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 factorsSingle group study. Blood, saliva, anal cytology, and penile cytology samples, and questionnaire responses will be collected from participants at a single study visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-1 infected men who have sex with men from Mumbai and Vellore, India, who are age 18 or older.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNA analysisAnal pap smear, penile pap smear, blood collection, and saliva collection at a single study visit for HPV DNA analysis. | Genetic | Specimen collection |
| polymerase chain reactionBlood and saliva samples collected at a single study visit will be analyzed for for HPV DNA. | Genetic | Specimen collection |
| fluorescence activated cell sortingBlood and saliva samples collected at a single study visit will be analyzed for for HPV DNA. | Other | Specimen collection |
| questionnaire administrationDescribe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM. | Other | Specimen collection |
| study of socioeconomic and demographic variablesDescribe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM. | Other | Specimen collection |
| study of high risk factorsDescribe risk factors for penile, anal and oral HPV infection in Indian HIV-seropositive MSM. | Procedure or surgery | Specimen collection |
Primary outcome
Detectable human papilloma virus DNA in the penis, anus, or mouth
Time frame: Study entry
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Palefsky, MD study chair
University of California, San Francisco
Dilip Mathai, MD principal investigator
Christian Medical College and Hospital
Ashok Row Kavi principal investigator
Humsafar Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nonneoplastic Condition and Precancerous Condition, run by AIDS Malignancy Consortium at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detectable human papilloma virus DNA in the penis, anus, or mouth (time frame: Study entry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.