Trial Information

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

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.