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)
NCT ID: NCT00000751
Last Updated: 2008-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1600 participants
INTERVENTIONAL
2007-08-31
Brief Summary
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Vertical transmission of HIV from mother to child may occur before, during, or after parturition (via breast-feeding). It is believed that therapy administered both during pregnancy and intrapartum may help prevent vertical transmission. Additionally, adjunctive short-term antiretroviral therapy for the newborn, following the intensive viral exposure presumed to occur at birth, may be necessary.
Detailed Description
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Pregnant women who are currently receiving AZT are randomized at 20-30 weeks of gestation to begin receiving either HIVIG or IVIG every 28 days up to delivery. Within 12 hours after birth, the infant receives an infusion of matching study drug. During labor, all women receive an intravenous loading dose of AZT administered over 1 hour, followed by continuous infusion during the intrapartum period until the umbilical cord is clamped. All infants receive AZT syrup every 6 hours, beginning as soon as oral fluids are tolerated but within 8-12 hours after birth and continuing for 6 weeks. Women are followed until 26 weeks postpartum. Infants are followed at weeks 1, 2, 4, and then every 4 weeks through week 24, every 12 weeks through week 60, at week 78 (18 months), and at week 104 (24 months).
Conditions
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Keywords
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Study Design
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PARALLEL
TREATMENT
Interventions
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Anti-HIV Immune Serum Globulin (Human)
Globulin, Immune
Zidovudine
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Women - Medications as required for obstetrical management of HIV infection (e.g., acyclovir, ketoconazole, isoniazid, antibiotics, or other antiretroviral therapy if intolerant or failing on AZT), unless specifically excluded.
* Infants - Drug treatment for signs of drug withdrawal (phenobarbital, chlorpromazine, tincture of opium, paregoric or Valium).
* Infants - Medications as indicated for management of an HIV-exposed infant (e.g., hepatitis B vaccine, syphilis treatment, Pneumocystis carinii pneumonia prophylaxis).
Patients must have:
* Documented HIV infection.
* Been receiving AZT during current pregnancy for medical indications.
* Gestational age between 20 and 30 weeks.
* Intention to carry pregnancy to term.
* Available venous access (placement of central line or Hickman catheter not indicated for study purposes).
* Willingness to be followed by a participating site for study duration.
NOTE:
* Father of fetus (if available after a reasonable attempt to contact him) must also provide informed consent.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Illness associated with excessive protein loss, e.g., severe proteinuria (protein \>= 4 g protein in a 24-hour urine collection).
Patients with the following prior conditions are excluded:
* Evidence of pre-existing fetal anomalies (e.g., anencephaly, renal agenesis, or Potter's syndrome) that may result in a high probability that the fetus-infant would not survive to the end of the study period.
* Chorionic villus sampling (CVS) or percutaneous umbilical blood sampling (PUBS) occurring in this pregnancy prior to study entry.
* Illness associated with excessive protein loss, e.g., chronic diarrhea with no documented weight gain in a 3-month period during pregnancy.
* Pre-existing conditions such as hypogammaglobulinemia or immune thrombocytopenia that are felt to require IVIG therapy.
Prior Medication:
Excluded:
* Receipt of anti-HIV vaccines or passive immunotherapy with HIVIG or IVIG during this pregnancy prior to study entry.
* Receipt of antiretroviral agents other than AZT during this pregnancy prior to study entry (e.g., rCD4, CD4-IgG, d4T, ddC, ddI).
13 Years
60 Years
FEMALE
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Principal Investigators
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ER Stiehm
Role: STUDY_CHAIR
J Lambert
Role: STUDY_CHAIR
Locations
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UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Denver Gen Hosp
Denver, Colorado, United States
Children's Hosp of Denver
Denver, Colorado, United States
Univ of Connecticut / Farmington
Farmington, Connecticut, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States
Washington Hosp Ctr
Washington D.C., District of Columbia, United States
Howard Univ Hosp
Washington D.C., District of Columbia, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States
Univ Hosp
New Orleans, Louisiana, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Brigham and Women's Hosp
Boston, Massachusetts, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, United States
Children's Hosp of Michigan
Detroit, Michigan, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Children's Hosp at Albany Med Ctr
Albany, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Mount Sinai Med Ctr / Pediatrics
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
State Univ of New York at Stony Brook
Stony Brook, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, United States
Case Western Reserve Univ - Pediatric
Cleveland, Ohio, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
Hosp of the Univ of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States
Temple Univ School of Medicine
Philadelphia, Pennsylvania, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Regional Med Ctr at Memphis
Memphis, Tennessee, United States
Methodist Hosp Central
Memphis, Tennessee, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
Children's Med Ctr of Dallas
Dallas, Texas, United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, , Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
San Juan City Hosp
San Juan, , Puerto Rico
Countries
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References
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Mofenson LM. Interventions to reduce perinatal transmission. Natl Conf Women HIV. 1997 May 4-7:125 (abstract no 2011)
McKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
Lambert J, Fletcher C, Mofenson L, Stiehm ER, Moye J, Meyer W, Nemo G, Mathieson B, Hirsch G. Pharmacokinetics (PK) of hyperimmune HIV immunoglobulin (HIVIG) in HIV+ pregnant females & newborns. Natl Conf Hum Retroviruses Relat Infect (2nd). 1995 Jan 29-Feb 2:148
Lambert JS, Watts DH, Mofenson L, Stiehm ER, Harris DR, Bethel J, Whitehouse J, Jimenez E, Gandia J, Scott G, O'Sullivan MJ, Kovacs A, Stek A, Shearer WT, Hammill H, van Dyke R, Maupin R, Silio M, Fowler MG. Risk factors for preterm birth, low birth weight, and intrauterine growth retardation in infants born to HIV-infected pregnant women receiving zidovudine. Pediatric AIDS Clinical Trials Group 185 Team. AIDS. 2000 Jul 7;14(10):1389-99. doi: 10.1097/00002030-200007070-00012.
Mofenson LM, Lambert JS, Stiehm ER, Bethel J, Meyer WA 3rd, Whitehouse J, Moye J Jr, Reichelderfer P, Harris DR, Fowler MG, Mathieson BJ, Nemo GJ. Risk factors for perinatal transmission of human immunodeficiency virus type 1 in women treated with zidovudine. Pediatric AIDS Clinical Trials Group Study 185 Team. N Engl J Med. 1999 Aug 5;341(6):385-93. doi: 10.1056/NEJM199908053410601.
Lambert JS, Mofenson LM, Fletcher CV, Moye J Jr, Stiehm ER, Meyer WA 3rd, Nemo GJ, Mathieson BJ, Hirsch G, Sapan CV, Cummins LM, Jimenez E, O'Neill E, Kovacs A, Stek A. Safety and pharmacokinetics of hyperimmune anti-human immunodeficiency virus (HIV) immunoglobulin administered to HIV-infected pregnant women and their newborns. Pediatric AIDS Clinical Trials Group Protocol 185 Pharmacokinetic Study Group. J Infect Dis. 1997 Feb;175(2):283-91. doi: 10.1093/infdis/175.2.283.
Lambert JS, Moye J, Sapan C, Mofenson L, Fletcher C, Whitehouse J, Fowler MG, Nemo G, Stiehm ER. Demonstration of feasibility and preliminary safety and pharmaco-kinetics in a phase III study of hyperimmune HIV intravenous immunoglobulin (HIV-IG) to prevent maternal-fetal HIV transmission. Int Conf AIDS. 1996 Jul 7-12;11(2):84 (abstract no WeB3163)
Frenkel LM. Therapeutic issues pertaining to HIV-1 infected pregnant women in developed countries. 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29
Watts DH, Lambert J, Stiehm ER, Harris DR, Bethel J, Mofenson L, Meyer WA 3rd, Mathieson B, Fowler MG, Nemo G; PACTG 185 Study Team. Progression of HIV disease among women following delivery. J Acquir Immune Defic Syndr. 2003 Aug 15;33(5):585-93. doi: 10.1097/00126334-200308150-00006.
Lambert JS. HIV vaccines in infants and children. Paediatr Drugs. 2005;7(5):267-76. doi: 10.2165/00148581-200507050-00001.
Other Identifiers
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ACTG 185
Identifier Type: -
Identifier Source: org_study_id