A Phase III Randomized Trial of Topical Vaginal Fluorouracil (5-Fluorouracil, 5-FU) Maintenance Therapy Versus Observation After Standard Treatment for High-Grade Cervical Dysplasia in HIV-Infected Women

PHASE3CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

Not specified

Study Completion Date

April 30, 1998

Conditions
HIV InfectionsCervix, Dysplasia
Interventions
DRUG

Fluorouracil

Trial Locations (21)

10021

Memorial Sloan-Kettering Cancer Ctr., New York

10457

Bronx-Lebanon Hosp. IMPAACT CRS, The Bronx

13210

SUNY Upstate Med. Univ., Dept. of Peds., Syracuse

14215

SUNY - Buffalo, Erie County Medical Ctr., Buffalo

14642

Univ. of Rochester ACTG CRS, Rochester

21287

Johns Hopkins Adult AIDS CRS, Baltimore

27599

Unc Aids Crs, Chapel Hill

33136

Univ. of Miami AIDS CRS, Miami

45267

Univ. of Cincinnati CRS, Cincinnati

48201

Children's Hospital of Michigan NICHD CRS, Detroit

60611

Northwestern University CRS, Chicago

60612

Cook County Hosp. CORE Ctr., Chicago

60637

Univ. of Chicago - Dept. of Peds., Div. of Infectious Disease, Chicago

70112

Tulane/LSU Maternal/Child CRS, New Orleans

90033

Usc La Nichd Crs, Los Angeles

98122

UW School of Medicine - CHRMC, Seattle

02118

Bmc Actg Crs, Boston

02215

Beth Israel Deaconess Med. Ctr., ACTG CRS, Boston

07103

NJ Med. School CRS, Newark

00936

Puerto Rico-AIDS CRS, San Juan

San Juan City Hosp. PR NICHD CRS, San Juan

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH