A Study of Anal Cancer Development in HIV Infected People

Study Overview
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Brief Summary
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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
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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.

Official Title
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Anal Dysplasia: A Substudy of a Large, Simple Trial Comparing Two Strategies for Management of Anti-Retroviral Therapy (The SMART Study)

Conditions
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HIV Infections, Anus Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Current or prior history of anal or cervical cancer Permanent or irreversible bleeding disorder that would interfere with biopsy of the anal canal

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to high-grade anal dysplasia or anal cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment Experienced, HIV, HPV, Antiretroviral Therapy, Highly Active, Papillomavirus, Human