A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,600

Participants

Timeline

Start Date

Not specified

Study Completion Date

August 31, 2007

Conditions
HIV InfectionsPregnancy
Interventions
DRUG

Anti-HIV Immune Serum Globulin (Human)

DRUG

Globulin, Immune

DRUG

Zidovudine

Trial Locations (51)

10016

Bellevue Hosp / New York Univ Med Ctr, New York

10029

Mount Sinai Med Ctr / Pediatrics, New York

10032

Columbia Presbyterian Med Ctr, New York

10457

Bronx Lebanon Hosp Ctr, The Bronx

12208

Children's Hosp at Albany Med Ctr, Albany

13210

SUNY Health Sciences Ctr at Syracuse / Pediatrics, Syracuse

19104

Hosp of the Univ of Pennsylvania, Philadelphia

20060

Howard Univ Hosp, Washington D.C.

21201

Univ of Maryland at Baltimore / Univ Med Ctr, Baltimore

27710

Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr, Durham

32209

Univ of Florida Health Science Ctr / Pediatrics, Jacksonville

33161

Univ of Miami (Pediatric), Miami

38103

Regional Med Ctr at Memphis, Memphis

44106

Case Western Reserve Univ - Pediatric, Cleveland

48201

Children's Hosp of Michigan, Detroit

60612

Univ of Illinois College of Medicine / Pediatrics, Chicago

70112

Univ Hosp, New Orleans

75235

Children's Med Ctr of Dallas, Dallas

77030

Hermann Hosp / Univ Texas Health Science Ctr, Houston

Texas Children's Hosp / Baylor Univ, Houston

90033

Los Angeles County - USC Med Ctr, Los Angeles

94110

San Francisco Gen Hosp, San Francisco

117948111

State Univ of New York at Stony Brook, Stony Brook

191044318

Children's Hosp of Philadelphia, Philadelphia

191075098

Thomas Jefferson Univ Hosp, Philadelphia

191341095

Saint Christopher's Hosp for Children, Philadelphia

Temple Univ School of Medicine, Philadelphia

200102916

Children's Hosp of Washington DC, Washington D.C.

200102931

Washington Hosp Ctr, Washington D.C.

212874933

Johns Hopkins Hosp - Pediatric, Baltimore

294253312

Med Univ of South Carolina, Charleston

381052794

Methodist Hosp Central, Memphis

Saint Jude Children's Research Hosp of Memphis, Memphis

701122699

Tulane Univ / Charity Hosp of New Orleans, New Orleans

802044507

Denver Gen Hosp, Denver

802181088

Children's Hosp of Denver, Denver

900951752

UCLA Med Ctr / Pediatric, Los Angeles

905022004

Harbor - UCLA Med Ctr / UCLA School of Medicine, Los Angeles

920930672

UCSD Med Ctr / Pediatrics / Clinical Sciences, La Jolla

941430105

UCSF / Moffitt Hosp - Pediatric, San Francisco

981050371

Children's Hospital & Medical Center / Seattle ACTU, Seattle

06032

Univ of Connecticut / Farmington, Farmington

021155724

Children's Hosp of Boston, Boston

02115

Brigham and Women's Hosp, Boston

02118

Boston City Hosp / Pediatrics, Boston

01199

Baystate Med Ctr of Springfield, Springfield

016550001

Univ of Massachusetts Med School, Worcester

071032714

Univ of Medicine & Dentistry of New Jersey / Univ Hosp, Newark

00956

Ramon Ruiz Arnau Univ Hosp / Pediatrics, Bayamón

009365067

Univ of Puerto Rico / Univ Children's Hosp AIDS, San Juan

009367344

San Juan City Hosp, San Juan

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

lead

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

NCT00000751 - A Phase III Randomized, Double-Blind, Controlled Study of the Use of Anti-HIV Immune Serum Globulin (HIVIG) for the Prevention of Maternal-Fetal HIV Transmission in Pregnant Women and Newborns Receiving Zidovudine (AZT) | Biotech Hunter | Biotech Hunter