Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT01663558
Eligibility Criteria:
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, photocoagulation
* Use of anticoagulants (warfarin, heparin, Pradaxa)
* Inability to attend study visits
* Participation in any other drug study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01663558
Study Brief:
Protocol Section:
NCT01663558