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Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV

Phase 4
18 Years
Not Enrolling
Anal Dysplasia, Human Papilloma Virus, HIV

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Trial Information

Anal Dysplasia Study of Men Who Have Sex With Men Living With HIV

Inclusion Criteria:

- Male gender, ≥18 years of age

- HIV-infected and taking ARVs with suppressed HIV VL (<48 copies/mL) on 2 consecutive
measurements within the previous 6 months

- Any CD4 count will be considered appropriate for study

- Plasma INR < 1.5

- Plasma partial thromboplastin time (PTT) < 35s

- Blood WBC > 2.0x103/mm3 and absolute neutrophils count > 500

- Blood hemoglobin > 10.0 g/dL

- Blood platelet count > 50x103/mm3

- Serum total bilirubin < 6.0 mg/dL (subjects taking atazanavir-based ARV regimens may
have elevated total bilirubin but are generally < 6)

- Blood aspartate aminotransferase (AST) < 100 U/L (<2 ULN)

- Blood alanine aminotransferase (ALT) < 130 U/L (<2 ULN)

- Serum creatinine < 1.5 mg/dL

- ECOG performance status < 3

- Tricare beneficiary

Exclusion Criteria:

- History of AIN

- Anal canal condyloma requiring surgical treatment

- Anal cancer (current or history of)

- History of prior anal surgery, including hyfrecation, excision, cryotherapy,

- Use of anticoagulants (warfarin, heparin, Pradaxa)

- Inability to attend study visits

- Participation in any other drug study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

cytologic grade

Outcome Description:

Anal Pap cytologic grade, including regression and recurrence during course of study

Outcome Time Frame:

3 months

Safety Issue:


Principal Investigator

Robert J. Carpenter, DO FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

July 2013

Completion Date:

Related Keywords:

  • Anal Dysplasia
  • Human Papilloma Virus
  • HIV
  • anal dysplasia
  • HPV
  • HIV
  • MSM
  • Papilloma
  • Hyperplasia



NMCSD San Diego, California  92103