HIV InfectionsNCT00107679
A Study of Anal Cancer Development in HIV Infected People
An observational study of HIV Infections and Anus Neoplasms, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites in United States.
Trial summary
The purpose of this study is to compare the development of abnormal cell growth or cancer in the anal region of individuals who are receiving one of two different anti-HIV treatment strategies. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- HIV Infections, Anus Neoplasms
- How many people
- 560 participants
- Where
- 13 sitesUnited States
- Study dates
- Feb 2005to Mar 2006
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Coenrollment in the SMART study
- Normal anal cytology result. If baseline anal cytology is abnormal, high-resolution anoscopy must be performed and specimens must be obtained.
- Parent or guardian willing to provide informed consent, if applicable
Who cannot join
- Current or prior history of anal or cervical cancer
- Permanent or irreversible bleeding disorder that would interfere with biopsy of the anal canal
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
CRI-Boston CRS
Boston, Massachusetts, 02115
Univ. of Colorado Health Science Ctr. CRS
Denver, Colorado, 80204-4507
Eastside Family Health Ctr. CRS
Denver, Colorado, 80205
Henry Ford Hosp. CRS
Detroit, Michigan, 48202
Houston AIDS Research Team CRS
Houston, Texas, 77030
Univ. of Florida, Div. of Infectious Diseases CRS
Jacksonville, Florida, 32206
LA Gay & Lesbian Community Service Ctr., Lamba Med. Group CRS
Los Angeles, California, 90028
Harlem Hospital Ctr./Columbia University CRS (Gordin CTU)
New York, New York, 10037-1802
Temple Univ. School of Medicine CRS
Philadelphia, Pennsylvania, 19140
Kaiser Immune Deficiency Clinic of Portland CRS
Portland, Oregon, 97227
Oregon Health & Sciences Univ. Internal Medicine (L-475) CRS
Portland, Oregon, 97239
Castro-Mission Health Ctr. CRS
San Francisco, California, 94114
Washington DC VAMC, Washington Regional AIDS Program, Infectious Diseases CRS
Washington D.C., District of Columbia, 20422
About this study
Official title: Anal Dysplasia: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
The purpose of this study is to compare the development of abnormal cell growth or cancer in the anal region of individuals who are receiving one of two different anti-HIV treatment strategies.
Read the detailed description
Human papillomavirus (HPV) is a common viral infection among men and women. Individuals with HPV are at risk for anal dysplasia, a condition that may lead to anal cancer. It has been observed that HIV progresses more rapidly in individuals coinfected with HPV and HIV, compared to people with either disease alone. Studies that have investigated the effect of highly active antiretroviral therapy (HAART) on the progression of anal dysplasia have been contradictory and inconclusive. The role of CD4 count and HIV suppression and their contributions to the progression of anal disease needs to be determined. This trial is a substudy of a study of management of antiretroviral therapy (SMART). In the SMART study, patients will participate in one of two strategies: a drug conservation (DC) strategy and a viral suppression (VS) strategy. Participants in the DC group will stop or defer HAART, then receive episodic HAART treatment for the minimum time needed to maintain a CD4 cell count of at least 250 cells/mm3. Participants in the VS group will receive HAART to maintain a viral load as low as possible, regardless of CD4 count. This study will compare the times to development of high-grade anal dysplasia or anal cancer in participants who are currently enrolled in the SMART study.
Patients will participate in this substudy and the main SMART study at the same time. At the baseline visit, participants will undergo an anal swab; some female participants will have a cervical swab as well. Participants will provide a detailed sexual history including sexually transmitted infections, a history of anal-related conditions, and a history of alcohol and recreational drug use. These procedures will be repeated at each annual follow-up visit. Some participants may undergo additional anal cytology and high-resolution anoscopy with biopsy. Participants will be followed until they develop high-grade anal dysplasia or anal cancer or when the SMART study closes, whichever comes first.
- Conditions
- HIV Infections, Anus Neoplasms
- Keywords
- Treatment Experienced, HIV, HPV, Antiretroviral Therapy, Highly Active, Papillomavirus, Human
- Medical subject headings
- HIV Infections, Anus Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to high-grade anal dysplasia or anal cancer
Secondary outcomes (8)
Time to anal cancer
time to low-grade or high-grade anal dysplasia
time to anal HPV infection
time to anal HPV infection with a specific strain, for types 16, 18, or 31
time to cervical HPV infection
time to cervical HPV infection with a specific strain, for types 16, 18, or 31
time to high-grade anal dysplasia
time from low-grade anal dysplasia to normal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2005 (estimated)
- Study startFeb 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 560 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Calvin Cohen, MD, MSc, Study chair, Community Research Initiative of New England
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107679
- Sponsor's protocol ID
- CPCRA 065G
- Other IDs
- SMART, 10117
- Status last verified
- Apr 2014
- First submitted
- 6 Apr 2005
- Last updated
- 17 Apr 2014
- Results posted
- No
Publications
Panther LA, Schlecht HP, Dezube BJ. Spectrum of human papillomavirus-related dysplasia and carcinoma of the anus in HIV-infected patients. AIDS Read. 2005 Feb;15(2):79-82, 85-6, 88, 91.
PubMed 15712398Heard I, Palefsky JM, Kazatchkine MD. The impact of HIV antiviral therapy on human papillomavirus (HPV) infections and HPV-related diseases. Antivir Ther. 2004 Feb;9(1):13-22.
PubMed 15040532Piketty C, Darragh TM, Da Costa M, Bruneval P, Heard I, Kazatchkine MD, Palefsky JM. High prevalence of anal human papillomavirus infection and anal cancer precursors among HIV-infected persons in the absence of anal intercourse. Ann Intern Med. 2003 Mar 18;138(6):453-9. doi: 10.7326/0003-4819-138-6-200303180-00008.
PubMed 12639077Manzione CR, Nadal SR, Calore EE. [Human papillomavirus oncogenicity and grade of anal intraepithelial neoplasia in HIV positive patients]. Rev Assoc Med Bras (1992). 2004 Jul-Sep;50(3):282-5. doi: 10.1590/s0104-42302004000300035. Epub 2004 Oct 21. Portuguese.
PubMed 15499480
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anal Dysplasia: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)
- ClinicalTrials.gov ID
- NCT00107679
- Acronym / sponsor ID
- CPCRA 065G
- Conditions
- HIV Infections, Anus Neoplasms
- Keywords
- Treatment Experienced, HIV, HPV, Antiretroviral Therapy, Highly Active, Papillomavirus, Human
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Feb 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 7 Apr 2005 (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.
The purpose of this study is to compare the development of abnormal cell growth or cancer in the anal region of individuals who are receiving one of two different anti-HIV treatment strategies.
Detailed description
Human papillomavirus (HPV) is a common viral infection among men and women. Individuals with HPV are at risk for anal dysplasia, a condition that may lead to anal cancer. It has been observed that HIV progresses more rapidly in individuals coinfected with HPV and HIV, compared to people with either disease alone. Studies that have investigated the effect of highly active antiretroviral therapy (HAART) on the progression of anal dysplasia have been contradictory and inconclusive. The role of CD4 count and HIV suppression and their contributions to the progression of anal disease needs to be determined. This trial is a substudy of a study of management of antiretroviral therapy (SMART). In the SMART study, patients will participate in one of two strategies: a drug conservation (DC) strategy and a viral suppression (VS) strategy. Participants in the DC group will stop or defer HAART, then receive episodic HAART treatment for the minimum time needed to maintain a CD4 cell count of at least 250 cells/mm3. Participants in the VS group will receive HAART to maintain a viral load as low as possible, regardless of CD4 count. This study will compare the times to development of high-grade anal dysplasia or anal cancer in participants who are currently enrolled in the SMART study.
Patients will participate in this substudy and the main SMART study at the same time. At the baseline visit, participants will undergo an anal swab; some female participants will have a cervical swab as well. Participants will provide a detailed sexual history including sexually transmitted infections, a history of anal-related conditions, and a history of alcohol and recreational drug use. These procedures will be repeated at each annual follow-up visit. Some participants may undergo additional anal cytology and high-resolution anoscopy with biopsy. Participants will be followed until they develop high-grade anal dysplasia or anal cancer or when the SMART study closes, whichever comes first.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Coenrollment in the SMART study
- Normal anal cytology result. If baseline anal cytology is abnormal, high-resolution anoscopy must be performed and specimens must be obtained.
- Parent or guardian willing to provide informed consent, if applicable
Key exclusion criteria (2 listed)
- Current or prior history of anal or cervical cancer
- Permanent or irreversible bleeding disorder that would interfere with biopsy of the anal canal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to high-grade anal dysplasia or anal cancer
8 secondary outcomes
Time to anal cancer
time to low-grade or high-grade anal dysplasia
time to anal HPV infection
time to anal HPV infection with a specific strain, for types 16, 18, or 31
time to cervical HPV infection
time to cervical HPV infection with a specific strain, for types 16, 18, or 31
time to high-grade anal dysplasia
time from low-grade anal dysplasia to normal
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 17 Apr 2014.
- Background: PubMed 15712398Panther LA, Schlecht HP, Dezube BJ. Spectrum of human papillomavirus-related dysplasia and carcinoma of the anus in HIV-infected patients. AIDS Read. 2005 Feb;15(2):79-82, 85-6, 88, 91.
- Background: PubMed 15040532Heard I, Palefsky JM, Kazatchkine MD. The impact of HIV antiviral therapy on human papillomavirus (HPV) infections and HPV-related diseases. Antivir Ther. 2004 Feb;9(1):13-22.
- Background: PubMed 12639077Piketty C, Darragh TM, Da Costa M, Bruneval P, Heard I, Kazatchkine MD, Palefsky JM. High prevalence of anal human papillomavirus infection and anal cancer precursors among HIV-infected persons in the absence of anal intercourse. Ann Intern Med. 2003 Mar 18;138(6):453-9. doi: 10.7326/0003-4819-138-6-200303180-00008.
- Background: PubMed 15499480Manzione CR, Nadal SR, Calore EE. [Human papillomavirus oncogenicity and grade of anal intraepithelial neoplasia in HIV positive patients]. Rev Assoc Med Bras (1992). 2004 Jul-Sep;50(3):282-5. doi: 10.1590/s0104-42302004000300035. Epub 2004 Oct 21. Portuguese.
- Click here for more information on CPCRA 065Link provided by the sponsor.
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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.
Calvin Cohen, MD, MSc study chair
Community Research Initiative of New England
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infections and Anus Neoplasms, run by National Institute of Allergy and Infectious Diseases (NIAID) at 13 sites 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?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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 17 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
Time to high-grade anal dysplasia or anal cancer. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00107679, which also lists 4 linked publications.
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 17 Apr 2014.