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Predictive Modeling of Anal Dysplasia Progression in HIV

18 Years
Open (Enrolling)
Neoplasms, Squamous Cell, Papillomavirus Infections

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Trial Information

Predictive Modeling of Anal Dysplasia Progression in HIV

Persons living with HIV-infection are at greatly increased risk for anal carcinoma and anal
intraepithelial neoplasia (AIN). Despite the overall improvement in HIV outcomes, the
incidence of anal carcinoma has not decreased with the advent of highly active
antiretroviral ther-apy. Further, there is substantial morbidity and mortality associated
with anal carcinoma in HIV-infected individuals. For these reasons, it is critically
important to develop effective screening and treatment strategies in this population. Anal
carcinoma is similar to cervical carcinoma in that they are both associated with infection
with human papillomavirus (HPV) and share similar cytologic features of dysplasia. Anal
cytology screening is ultimately expected to reduce the incidence of anal carcinoma similar
to that seen with cervical cancer after the introduction of cervical Pap screening. Given
the high frequency of abnormal cytology in patients with HIV and the need to confirm results
by high-resolution anoscopy, however, the implementation of screening programs requires a
substantial commitment of clinical resources. The workload and costs involved in following
up on abnormal cytology reduce the cost-effectiveness of screening and pose a significant
barrier to its widespread integration into routine HIV care. A model for predicting which
patients are at greatest risk for progressive of anal dysplasia is needed in order to
decrease the need for excessive confirmatory procedures in this population. Without such a
model, anal carcinoma screening may remain cost prohibitive for many HIV clinics.

The objective of this study is to develop a predictive model to identify patients who are at
greatest risk for progression of anal intraepithelial neoplastic changes. The central
hypotheses are: 1) that progression of early HPV-related anal dysplasia is associated with
environmental, virological, and host molecular factors and 2) that it is possible to develop
a predictive statistical model with a high sensitivity and specificity for predicting
disease progression. These hypotheses have been formulated on the basis of strong evidence
from studies of HPV-related cervical dysplasia that smoking, HPV E2 expression, HPV E6/E7
protein expression, high-risk HPV type, HPV viral load, p16 expression, p53 expression and
Ki67 expression are associated with progressive cervical dysplasia. The rationale for the
proposed research is that development of a predictive model will allow clinicians to design
more cost-effective screening and follow-up strategies which focus resources on intensively
testing only those patients with a significant risk for progression. Further, the models
developed will allow clinicians to identify a population of patients who may benefit from
early treatment interventions. Finally, information learned from this research may provide
information applicable to other HPV-related cancers.

Inclusion Criteria:

- HIV-infected

- Age > 18 years old

- Abnormal anal screening cytology

Exclusion Criteria:

- Inability to sign informed consent

- Life-threatening illness or other contraindication for high-resolution anoscopy

- anal intraepithelial neoplasia not confirmed by anal biopsy

- history of anal carcinoma

- history of HPV vaccination

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

histological diagnosis of high-grade squamous intra-epithelial lesion confirmed by anal biopsy

Outcome Time Frame:

12 months, 24 months, 36 months

Safety Issue:


Principal Investigator

Jaime C Robertson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cincinnati


United States: Federal Government

Study ID:




Start Date:

January 2009

Completion Date:

March 2014

Related Keywords:

  • Neoplasms, Squamous Cell
  • Papillomavirus Infections
  • Neoplasms, Squamous Cell
  • Papillomavirus Infections
  • HIV
  • Neoplasms
  • Neoplasms, Squamous Cell
  • Papillomavirus Infections



University of CincinnatiCincinnati, Ohio  45267-0502
Cincinnati VA Medical CenterCincinnati, Ohio  45220