Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions

PHASE3CompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

December 28, 2015

Primary Completion Date

December 5, 2023

Study Completion Date

May 2, 2024

Conditions
Anal Intraepithelial NeoplasiaHigh-grade Squamous Intraepithelial LesionHIV Infection
Interventions
DRUG

imiquimod

Given intra-anally

DRUG

fluorouracil

Given intra-anally

OTHER

questionnaire administration

Ancillary studies

OTHER

laboratory biomarker analysis

Correlative studies

Trial Locations (13)

10011

Laser Surgery Care, New York

10065

Cornell Clinical Trials Unit, New York Presbyterian Hospital, New York

Weill Medical College of Cornell University, New York

10461

Montefiore Medical Center, The Bronx

27157

Wake Forest University Health Sciences, Winston-Salem

30303

Emory University, Atlanta

70112

Louisiana State University Health Sciences Center - New Orleans, New Orleans

90035

UCLA CARE Center, Los Angeles

94115

UCSF-Mount Zion, San Francisco

94143

University of California, San Francisco, San Francisco

98101

Benaroya Research Institute at Virginia Mason Medical Center, Seattle

02118

Boston Medical Center, Boston

00936-3027

University of Puerto Rico, San Juan

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

The Emmes Company, LLC

INDUSTRY

collaborator

University of Arkansas

OTHER

lead

AIDS Malignancy Consortium

NETWORK

NCT02059499 - Imiquimod, Fluorouracil, or Observation in Treating HIV-Positive Patients With High-Grade Anal Squamous Skin Lesions | Biotech Hunter | Biotech Hunter