A Phase I Study to Evaluate the Safety and Immunogenicity of Recombinant HIV-1 Envelope Antigen in Children Born to HIV-Infected Mothers

PHASE1CompletedINTERVENTIONAL
Enrollment

156

Participants

Timeline

Start Date

Not specified

Study Completion Date

January 31, 1999

Conditions
HIV InfectionsHIV Seronegativity
Interventions
BIOLOGICAL

rgp120/HIV-1MN

Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

BIOLOGICAL

rgp120/HIV-1 SF-2

Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

BIOLOGICAL

Placebo version of rgp120/HIV-1MN

Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

BIOLOGICAL

Placebo version of rgp120/HIV-1SF2

Administered at weeks 0, 4, 8, 12, and 20. Individual group assignment will determine specific dosage and schedule.

Trial Locations (37)

10016

NYU Med. Ctr., Dept. of Medicine, New York

10032

Columbia IMPAACT CRS, New York

Incarnation Children's Ctr., New York

10457

Bronx-Lebanon Hosp. IMPAACT CRS, The Bronx

13210

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

14642

Strong Memorial Hospital Rochester NY NICHD CRS, Rochester

19104

Univ. of Pennsylvania Health System, Hosp. of the Univ. of Pennsylvania, Philadelphia

32209

Univ. of Florida Jacksonville NICHD CRS, Jacksonville

33161

Univ. of Miami Ped. Perinatal HIV/AIDS CRS, Miami

60612

Cook County Hosp., Chicago

77030

Texas Children's Hosp. CRS, Houston

90801

Long Beach Memorial Med. Ctr., Miller Children's Hosp., Long Beach

94110

San Francisco Gen. Hosp., San Francisco

117948111

SUNY Stony Brook NICHD CRS, Stony Brook

191044318

The Children's Hosp. of Philadelphia IMPAACT CRS, Philadelphia

212874933

Johns Hopkins Hosp. & Health System - Dept. of Peds., Div. of Infectious Diseases, Baltimore

277103499

DUMC Ped. CRS, Durham

606143394

Chicago Children's CRS, Chicago

606371470

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

701122699

Tulane Univ. Health Science Ctr., Tulane Univ. Hosp. & Clinic, New Orleans

802181088

Univ. of Colorado Denver NICHD CRS, Aurora

900951752

UCLA-Los Angeles/Brazil AIDS Consortium (LABAC) CRS, Los Angeles

905022004

Harbor - UCLA Med. Ctr. - Dept. of Peds., Div. of Infectious Diseases, Torrance

920930672

UCSD Maternal, Child, and Adolescent HIV CRS, San Diego

941430105

UCSF Pediatric AIDS CRS, San Francisco

981050371

UW School of Medicine - CHRMC, Seattle

06504

Yale Univ. School of Medicine - Dept. of Peds., Div. of Infectious Disease, New Haven

Unknown

Tulane/LSU Maternal/Child CRS, New Orleans

HMS - Children's Hosp. Boston, Div. of Infectious Diseases, Boston

St. Joseph's Hosp. & Med. Ctr. of New Jersey, Paterson

Univ. of Rochester ACTG CRS, Rochester

WNE Maternal Pediatric Adolescent AIDS CRS, Worcester

02115

Brigham and Women's Hosp., Div. of Infectious Disease, Boston

02118

BMC, Div. of Ped Infectious Diseases, Boston

01199

Baystate Health, Baystate Med. Ctr., Springfield

07103

NJ Med. School CRS, Newark

009367344

San Juan City Hosp. PR NICHD CRS, San Juan

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

Biocine

INDUSTRY

lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH