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AzTrials

HIV InfectionsPhase 3NCT00000751

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)

A Phase 3 study testing Anti-HIV Immune Serum Globulin (Human), Globulin, Immune and Zidovudine in people with HIV Infections and Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 51 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT) administered intrapartum and to the newborn, on incidence of HIV infection in infants born to HIV-infected women who received AZT during… Read more about this study

Who is it for?
Ages 13 to 60 years, women only
Conditions the study is for
HIV Infections, Pregnancy
What is being tested?
Anti-HIV Immune Serum Globulin (Human), Globulin, Immune and Zidovudine
How many people
1,600 participants
Where
51 sitesin 2 countries
Study dates
Start not givento Aug 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 60 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Concurrent Medication:
  • 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:
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  • 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.

Who cannot join

  • Co-existing Condition:
  • 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.
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  • 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).

Trial locations and contacts

51 sites in 2 countries.

51 sites in 2 countries

United States48 sites

  • Children's Hosp at Albany Med Ctr

    Albany, New York, 12208

  • Univ of Maryland at Baltimore / Univ Med Ctr

    Baltimore, Maryland, 21201

  • Johns Hopkins Hosp - Pediatric

    Baltimore, Maryland, 212874933

  • Children's Hosp of Boston

    Boston, Massachusetts, 021155724

  • Brigham and Women's Hosp

    Boston, Massachusetts, 02115

  • Boston City Hosp / Pediatrics

    Boston, Massachusetts, 02118

  • Med Univ of South Carolina

    Charleston, South Carolina, 294253312

  • Univ of Illinois College of Medicine / Pediatrics

    Chicago, Illinois, 60612

  • Case Western Reserve Univ - Pediatric

    Cleveland, Ohio, 44106

  • Children's Med Ctr of Dallas

    Dallas, Texas, 75235

  • Denver Gen Hosp

    Denver, Colorado, 802044507

  • Children's Hosp of Denver

    Denver, Colorado, 802181088

  • Children's Hosp of Michigan

    Detroit, Michigan, 48201

  • Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr

    Durham, North Carolina, 27710

  • Univ of Connecticut / Farmington

    Farmington, Connecticut, 06032

  • Hermann Hosp / Univ Texas Health Science Ctr

    Houston, Texas, 77030

  • Texas Children's Hosp / Baylor Univ

    Houston, Texas, 77030

  • Univ of Florida Health Science Ctr / Pediatrics

    Jacksonville, Florida, 32209

  • UCSD Med Ctr / Pediatrics / Clinical Sciences

    La Jolla, California, 920930672

  • Los Angeles County - USC Med Ctr

    Los Angeles, California, 90033

  • UCLA Med Ctr / Pediatric

    Los Angeles, California, 900951752

  • Harbor - UCLA Med Ctr / UCLA School of Medicine

    Los Angeles, California, 905022004

  • Regional Med Ctr at Memphis

    Memphis, Tennessee, 38103

  • Methodist Hosp Central

    Memphis, Tennessee, 381052794

  • Saint Jude Children's Research Hosp of Memphis

    Memphis, Tennessee, 381052794

  • Univ of Miami (Pediatric)

    Miami, Florida, 33161

  • Tulane Univ / Charity Hosp of New Orleans

    New Orleans, Louisiana, 701122699

  • Univ Hosp

    New Orleans, Louisiana, 70112

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Mount Sinai Med Ctr / Pediatrics

    New York, New York, 10029

  • Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp

    Newark, New Jersey, 071032714

  • Children's Hosp of Philadelphia

    Philadelphia, Pennsylvania, 191044318

  • Hosp of the Univ of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson Univ Hosp

    Philadelphia, Pennsylvania, 191075098

  • Saint Christopher's Hosp for Children

    Philadelphia, Pennsylvania, 191341095

  • Temple Univ School of Medicine

    Philadelphia, Pennsylvania, 191341095

  • San Francisco Gen Hosp

    San Francisco, California, 94110

  • UCSF / Moffitt Hosp - Pediatric

    San Francisco, California, 941430105

  • Children's Hospital & Medical Center / Seattle ACTU

    Seattle, Washington, 981050371

  • Baystate Med Ctr of Springfield

    Springfield, Massachusetts, 01199

  • State Univ of New York at Stony Brook

    Stony Brook, New York, 117948111

  • SUNY Health Sciences Ctr at Syracuse / Pediatrics

    Syracuse, New York, 13210

  • Bronx Lebanon Hosp Ctr

    The Bronx, New York, 10457

  • Children's Hosp of Washington DC

    Washington D.C., District of Columbia, 200102916

  • Washington Hosp Ctr

    Washington D.C., District of Columbia, 200102931

  • Howard Univ Hosp

    Washington D.C., District of Columbia, 20060

  • Univ of Massachusetts Med School

    Worcester, Massachusetts, 016550001

Other trials in United States

Puerto Rico3 sites

  • Ramon Ruiz Arnau Univ Hosp / Pediatrics

    Bayamón, 00956

  • Univ of Puerto Rico / Univ Children's Hosp AIDS

    San Juan, 009365067

  • San Juan City Hosp

    San Juan, 009367344

Other trials in Puerto Rico

About this study

To evaluate the effect of anti-HIV immune serum globulin (HIVIG) versus immune globulin (IVIG) administered during pregnancy and to the newborn, in combination with zidovudine (AZT) administered intrapartum and to the newborn, on incidence of HIV infection in infants born to HIV-infected women who received AZT during pregnancy for medical indications.

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.

Read the detailed description

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.

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).

Being tested
Anti-HIV Immune Serum Globulin (Human), Globulin, Immune, Zidovudine
Keywords
Pregnancy, Pregnancy Complications, Infectious, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Zidovudine, Immunoglobulins, Intravenous, Immunization, Passive
Medical subject headings
HIV Infections, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-HIV Immune Serum Globulin (Human)Drug

  • Globulin, ImmuneDrug

  • ZidovudineDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2001 (estimated)
  2. Study completionAug 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Intervention model
Parallel groups
Enrolment
1,600 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000751
Sponsor's protocol ID
ACTG 185
Status last verified
May 2006
First submitted
2 Nov 1999
Last updated
30 Sep 2008
Results posted
No

Publications

  • 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.

    PubMed 10930154

  • 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.

    PubMed 10432323

  • 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.

    PubMed 9203648

  • 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.

    PubMed 12902802

  • Lambert JS. HIV vaccines in infants and children. Paediatr Drugs. 2005;7(5):267-76. doi: 10.2165/00148581-200507050-00001.

    PubMed 16220994

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Anti-HIV Immune Serum Globulin (Human), Globulin, Immune and Zidovudine in people with HIV Infections and Pregnancy, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 51 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000751, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2008.

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