Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions

PHASE3CompletedINTERVENTIONAL
Enrollment

4,446

Participants

Timeline

Start Date

September 24, 2014

Primary Completion Date

August 6, 2021

Study Completion Date

March 31, 2024

Conditions
Anal CancerHigh-grade Squamous Intraepithelial LesionHIV InfectionHuman Papilloma Virus Infection
Interventions
DRUG

imiquimod

Applied topically

DRUG

fluorouracil

Applied topically

DEVICE

infrared photocoagulation therapy

Undergo infrared coagulation

DEVICE

thermal ablation therapy

Undergo hyfrecation/electrocautery therapy

DEVICE

laser therapy

Undergo laser therapy

OTHER

clinical observation

Undergo active monitoring (High Resolution Anoscopy \[HRA\]) with biopsies

OTHER

laboratory biomarker analysis

Correlative studies

Trial Locations (25)

10010

Cornell Clinical Trials Unit, Chelsea Center, New York

10011

Laser Surgery Care, New York

10461

Montefiore - Albert Einstein College of Medicine, The Bronx

20006

Capital Digestive Care, Washington D.C.

20009

Dupont Circle Physicians Group, Washington D.C.

27157

Wake Forest Baptist Health, Winston-Salem

30303

Grady Health System, Atlanta

33136

ACC Clinic, Jackson Hospital, Miami

University of Miami Miller School of Medicine - Sylvester Cancer Center, Miami

60614

Anal Dysplasia Clinic MidWest, Chicago

70112

University Medical Center New Orleans, New Orleans

70119

CrescentCare Health, New Orleans

80045

University of Colorado Hospital, Aurora

80204

Denver Public Health, Denver

90035

UCLA CARE Clinic, Los Angeles

90095

UCLA School of Nursing, Los Angeles

92262

DAP Health, Palm Springs

94115

University of California at San Francisco Anal Dysplasia Clinic, San Francisco

98101

Virginia Mason Medical Center, Seattle

98104

Harborview Medical Center, Seattle

The Polyclinic, Seattle

02118

Boston Medical Center, Boston

02215

Fenway Health, Boston

07103

Rutgers University New Jersey Medical School, Newark

00936

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

collaborator

University of California, San Francisco

OTHER

collaborator

University of Arizona

OTHER

lead

AIDS Malignancy Consortium

NETWORK

NCT02135419 - Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions | Biotech Hunter | Biotech Hunter