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HIV InfectionsPhase 3NCT00000960

The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants

A Phase 3 study testing Zidovudine in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 62 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 determine whether the rate of HIV transmission from mother to infant can be reduced by continuous oral zidovudine (AZT) treatment to HIV infected pregnant women, intravenous AZT during childbirth, and oral AZT treatment of the newborn infant from birth to six weeks of age. Read more about this study

Who is it for?
Ages 1 day to 60 years
Conditions the study is for
HIV Infections, Pregnancy
What is being tested?
Zidovudine
How many people
1,496 participants
Where
62 sitesin 2 countries
Study dates
Start not givento Jun 1994
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 1 day to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Concurrent Medication:
  • Allowed for infants:
  • Treatment for signs of drug withdrawal (e.g., phenobarbital, chlorpromazine, tincture of opium, paregoric, or Valium).
  • Treatment for nonserious conditions (e.g., syphilis treatment, hepatitis B vaccine).
  • All essential supportive treatment for conditions that are nonlife threatening as deemed by the on-site pediatrician.
  • Acetaminophen.
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  • Standard immunizations.
  • Allowed for women:
  • All medications/treatments as required for normal OB care of HIV+ women, except as noted under exclusions.
  • Pneumocystis prophylaxis as indicated.
  • Topical steroids. Parenteral and oral steroids for 6 or fewer days.
  • Concurrent Treatment:
  • Allowed for pregnant woman:
  • Blood transfusion for anemia (hemoglobin less than 7 g/dl).
  • Allowed for infant:
  • Blood transfusions for anemia except if attributed to study drug.
  • -
  • Patients must:
  • Have HIV infection.
  • Intend to carry pregnancy to term.
  • Be willing to be followed by a participating ACTG center for duration of the study.
  • Be able to provide informed consent (if available, father of the fetus must also provide informed consent).
  • Infants may enroll simultaneously in other pediatric protocols after completing the initial 6 weeks of study treatment.
  • Inclusion age for women is 13 years old or more or IRB local age of consent.

Who cannot join

  • Co-existing Condition:
  • Infants with the following conditions or symptoms are excluded:
  • Requiring treatment for hyperbilirubinemia (except phototherapy).
  • Concurrent Medication:
  • Excluded:
  • Infants:
Show all 20Show fewer
  • Antiretroviral drugs or vaccines.
  • Excluded during current pregnancy:
  • Zidovudine (AZT).
  • Other antiretroviral agents (e.g., rCD4, CD4-IgG, d4T, didanosine (ddI), dideoxycytidine (ddC)), passive immunotherapy (e.g., HIVIG), anti-HIV vaccines, cytolytic chemotherapeutic agents.
  • Corticosteroids for equal to or more than 7 days.
  • Patients with the following are excluded:
  • Evidence of preexisting fetal anomalies that may (1) result in a high probability that the fetus/infant will not survive to the end of the study period (e.g., anencephaly, renal agenesis, or Potter's syndrome); or (2) increase the fetal tissue concentration of zidovudine (AZT) or its metabolites to a toxic level (e.g., neural tube or ventral wall defects).
  • Baseline sonogram completed within 28 days prior to randomization that demonstrates 2nd trimester findings of anencephaly or oligohydramnios, or 3rd trimester findings of unexplained polyhydramnios, fetal hydrops, ascites or other evidence of preexisting in-utero anemia.
  • History of intolerance to AZT dose of 500 or less mg/day prior to this pregnancy that resulted in discontinuation of treatment for more than 4 weeks.
  • Recipient of AZT during current pregnancy for any indication or meet criteria for AZT as defined by this protocol (CD4+ cell counts less than 200 cells/mm3 or AIDS).
  • Infants not having parent/guardian available to give informed consent if necessary.
  • Prior Treatment:
  • Excluded during current pregnancy:
  • Radiation therapy.

Trial locations and contacts

62 sites in 2 countries.

62 sites in 2 countries

United States58 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

  • Johns Hopkins Hosp

    Baltimore, Maryland, 21287

  • Univ of Alabama at Birmingham Schl of Med / Pediatrics

    Birmingham, Alabama, 35294

  • Univ of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Children's Hosp of Boston

    Boston, Massachusetts, 021155724

  • Boston City Hosp / Pediatrics

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Med Ctr

    Boston, Massachusetts, 02215

  • SUNY - Brooklyn

    Brooklyn, New York, 11203

  • SUNY / Health Sciences Ctr at Brooklyn / Pediatrics

    Brooklyn, New York, 11203

  • Univ of North Carolina

    Chapel Hill, North Carolina, 275997215

  • Med Univ of South Carolina

    Charleston, South Carolina, 294253312

  • Carolinas Med Ctr

    Charlotte, North Carolina, 28203

  • Northwestern Univ Med School

    Chicago, Illinois, 60611

  • Cook County Hosp

    Chicago, Illinois, 60612

  • Univ of Illinois College of Medicine / Pediatrics

    Chicago, Illinois, 60612

  • Chicago Children's Memorial Hosp

    Chicago, Illinois, 606143394

  • Univ of Chicago Children's Hosp

    Chicago, Illinois, 606371470

  • Univ of Cincinnati

    Cincinnati, Ohio, 452670405

  • Children's Med Ctr of Dallas

    Dallas, Texas, 75235

  • Children's Hosp of Denver

    Denver, Colorado, 802181088

  • Children's Hosp of Michigan

    Detroit, Michigan, 48201

  • Duke Univ Med Ctr

    Durham, North Carolina, 277103499

  • Univ of Connecticut / Farmington

    Farmington, Connecticut, 06032

  • Univ of Connecticut Health Ctr

    Farmington, Connecticut, 06032

  • Lyndon Baines Johnson Gen Hosp

    Houston, Texas, 77030

  • Texas Children's Hosp / Baylor Univ

    Houston, Texas, 77030

  • 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

  • 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

  • Beth Israel Med Ctr / Pediatrics

    New York, New York, 10003

  • Bellevue Hosp / New York Univ Med Ctr

    New York, New York, 10016

  • Cornell Univ Med College

    New York, New York, 10021

  • Mount Sinai Med Ctr / Pediatrics

    New York, New York, 10029

  • Columbia Presbyterian Med Ctr

    New York, New York, 10032

  • UMDNJ - New Jersy Med School

    Newark, New Jersey, 071032714

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

    Newark, New Jersey, 071032714

  • Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl

    Newark, New Jersey, 071072198

  • Children's Hosp of Philadelphia

    Philadelphia, Pennsylvania, 191044318

  • Hosp of the Univ of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson Univ Hosp

    Philadelphia, Pennsylvania, 191075098

  • Rhode Island Hosp / Brown Univ

    Providence, Rhode Island, 02903

  • Univ of Rochester Medical Center

    Rochester, New York, 14642

  • San Francisco Gen Hosp

    San Francisco, California, 94110

  • Children's Hosp of Seattle

    Seattle, Washington, 98105

  • 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

  • Albert Einstein College of Medicine

    The Bronx, New York, 10461

  • Westchester Hosp

    Valhalla, New York, 10595

  • Howard Univ Hosp

    Washington D.C., District of Columbia, 20060

  • Univ of Massachusetts Med Ctr

    Worcester, Massachusetts, 01655

Other trials in United States

Puerto Rico4 sites

  • Ramon Ruiz Arnau Univ Hosp / Pediatrics

    Bayamón, 00956

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

    San Juan, 009365067

  • UPR Children's Hosp / UPR School of Medicine

    San Juan, 009365067

  • San Juan City Hosp

    San Juan, 009367344

Other trials in Puerto Rico

About this study

Official title: A Phase III Randomized Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerance of Oral Zidovudine (AZT) in Pregnant HIV Infected Women and Their Infants

To determine whether the rate of HIV transmission from mother to infant can be reduced by continuous oral zidovudine (AZT) treatment to HIV infected pregnant women, intravenous AZT during childbirth, and oral AZT treatment of the newborn infant from birth to six weeks of age. The study is also designed to evaluate the safety of AZT for both the pregnant woman and the newborn infant.

No method exists to prevent transmission of HIV from an infected mother to her newborn infant. Giving an antiviral agent (such as AZT) to the mother and to the newborn could in theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to maternal virus, or by preventive treatment of the fetus before exposure.

Read the detailed description

No method exists to prevent transmission of HIV from an infected mother to her newborn infant. Giving an antiviral agent (such as AZT) to the mother and to the newborn could in theory decrease the risk of infection to the newborn by reducing the exposure of the fetus to maternal virus, or by preventive treatment of the fetus before exposure.

Patients are enrolled during their pregnancy, between 14 and 34 weeks of gestation. They are chosen by random selection to receive AZT or placebo. Treatment continues until labor at which time they begin to receive continuous intravenous study drug. Study drug treatment is discontinued after the umbilical cord is clamped. AZT is then offered all women as per labeled indications for 6 weeks postpartum, while appropriate medical followup is being arranged. Mothers who develop an AIDS defining illness or whose CD4+ cell counts decrease to less than 200 cells/mm3 during pregnancy are offered open-label drug at that time. The mother is followed by her primary obstetrician at an AIDS Clinical Trials Unit (ACTU) or subunit facility. The mother may deliver at the ACTU or a non-ACTU site. Treatment of the infant is started in the newborn nursery and continues on an outpatient basis. Infants receive the same study treatment as the mother for 6 weeks, and are monitored to week 78.

Being tested
Zidovudine
Keywords
Pregnancy, Pregnancy Complications, Infectious, Prenatal Exposure Delayed Effects, Administration, Oral, AIDS-Related Complex, Zidovudine
Medical subject headings
HIV Infections, Pregnancy Complications, Infectious, Prenatal Exposure Delayed Effects, AIDS-Related Complex

What participants receive

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

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 completionJun 1994

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
Enrolment
1,496 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000960
Sponsor's protocol ID
ACTG 076
Other IDs
11050
Status last verified
Oct 2021
First submitted
2 Nov 1999
Last updated
29 Oct 2021
Results posted
No

Publications

  • Sperling RS, Shapiro DE, Coombs RW, Todd JA, Herman SA, McSherry GD, O'Sullivan MJ, Van Dyke RB, Jimenez E, Rouzioux C, Flynn PM, Sullivan JL. Maternal viral load, zidovudine treatment, and the risk of transmission of human immunodeficiency virus type 1 from mother to infant. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1996 Nov 28;335(22):1621-9. doi: 10.1056/NEJM199611283352201.

    PubMed 8965861

  • Connor EM, Sperling RS, Gelber R, Kiselev P, Scott G, O'Sullivan MJ, VanDyke R, Bey M, Shearer W, Jacobson RL, et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1994 Nov 3;331(18):1173-80. doi: 10.1056/NEJM199411033311801.

    PubMed 7935654

  • Sperling RS, Shapiro DE, McSherry GD, Britto P, Cunningham BE, Culnane M, Coombs RW, Scott G, Van Dyke RB, Shearer WT, Jimenez E, Diaz C, Harrison DD, Delfraissy JF. Safety of the maternal-infant zidovudine regimen utilized in the Pediatric AIDS Clinical Trial Group 076 Study. AIDS. 1998 Oct 1;12(14):1805-13. doi: 10.1097/00002030-199814000-00012.

    PubMed 9792381

  • Wiznia AA, Crane M, Lambert G, Sansary J, Harris A, Solomon L. Zidovudine use to reduce perinatal HIV type 1 transmission in an urban medical center. JAMA. 1996 May 15;275(19):1504-6.

    PubMed 8622226

  • Rouzioux C. Prevention of maternal HIV transmission. Practical guidelines. Drugs. 1995;49 Suppl 1:17-24; discussion 38-40. doi: 10.2165/00003495-199500491-00006.

    PubMed 7614898

  • Dickover RE, Garratty EM, Herman SA, Sim MS, Plaeger S, Boyer PJ, Keller M, Deveikis A, Stiehm ER, Bryson YJ. Identification of levels of maternal HIV-1 RNA associated with risk of perinatal transmission. Effect of maternal zidovudine treatment on viral load. JAMA. 1996 Feb 28;275(8):599-605.

    PubMed 8594240

  • Culnane M, Fowler M, Lee SS, McSherry G, Brady M, O'Donnell K, Mofenson L, Gortmaker SL, Shapiro DE, Scott G, Jimenez E, Moore EC, Diaz C, Flynn PM, Cunningham B, Oleske J. Lack of long-term effects of in utero exposure to zidovudine among uninfected children born to HIV-infected women. Pediatric AIDS Clinical Trials Group Protocol 219/076 Teams. JAMA. 1999 Jan 13;281(2):151-7. doi: 10.1001/jama.281.2.151.

    PubMed 9917118

  • Shearer WT, Quinn TC, LaRussa P, Lew JF, Mofenson L, Almy S, Rich K, Handelsman E, Diaz C, Pagano M, Smeriglio V, Kalish LA. Viral load and disease progression in infants infected with human immunodeficiency virus type 1. Women and Infants Transmission Study Group. N Engl J Med. 1997 May 8;336(19):1337-42. doi: 10.1056/NEJM199705083361901.

    PubMed 9134873

  • Frenkel LM, Cowles MK, Shapiro DE, Melvin AJ, Watts DH, McLellan C, Mohan K, Murante B, Burchett S, Bryson YJ, O'Sullivan MJ, Mitchell C, Landers D. Analysis of the maternal components of the AIDS clinical trial group 076 zidovudine regimen in the prevention of mother-to-infant transmission of human immunodeficiency virus type 1. J Infect Dis. 1997 Apr;175(4):971-4. doi: 10.1086/514003.

    PubMed 9086162

  • Newell ML, Gray G, Bryson YJ. Prevention of mother-to-child transmission of HIV-1 infection. AIDS. 1997;11 Suppl A:S165-72. No abstract available.

    PubMed 9451981

  • Edathodu J, Halim MM, Dahham MB, Alrajhi AA. Mother-to-child transmission of HIV: experience at a referral hospital in Saudi Arabia. Ann Saudi Med. 2010 Jan-Feb;30(1):15-7. doi: 10.4103/0256-4947.59367.

    PubMed 20103953

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zidovudine in people with HIV Infections and Pregnancy, run by National Institute of Allergy and Infectious Diseases (NIAID) at 62 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 24 inclusion and 20 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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 62 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 NCT00000960, which also lists 11 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 29 Oct 2021.

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