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The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants Clinical research trials and The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants. The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants clinical trial. Participants frequently get the best healthcare available for their The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants  The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants
The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants
For Condition: HIV Infections,Pregnancy
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Glaxo Wellcome
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /60 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. - 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. - Inclusion age for infants is 0 to 20 months. Exclusion Criteria Co-existing Condition: Infants with the following conditions or symptoms are excluded: - Requiring treatment for hyperbilirubinemia (except phototherapy). Concurrent Medication: Excluded: - Infants: - 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.
Total Enrollment: 1496
Location and Contact Information:
Overall Study Official:
EConnor, Study Chair,
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Lyndon Baines Johnson Gen Hosp
Houston, Texas, 77030
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Univ of Rochester Medical Center
Rochester, New York, 14642
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Children's Hosp of Seattle
Seattle, Washington, 98105
United States
Westchester Hosp
Valhalla, New York, 10595
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
SUNY - Brooklyn
Brooklyn, New York, 11203
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Univ of Alabama at Birmingham Schl of Med / Pediatrics
Birmingham, Alabama, 35294
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
UPR Children's Hosp / UPR School of Medicine
San Juan, , 009365067
Puerto Rico
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
UMDNJ - New Jersy Med School
Newark, New Jersey, 071032714
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Albert Einstein College of Medicine
Bronx, New York, 10461
United States
Carolinas Med Ctr
Charlotte, North Carolina, 28203
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Rhode Island Hosp / Brown Univ
Providence, Rhode Island, 02903
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
SUNY / Health Sciences Ctr at Brooklyn / Pediatrics
Brooklyn, New York, 11203
United States
Univ of Connecticut Health Ctr
Farmington, Connecticut, 06032
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, 02215
United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
Beth Israel Med Ctr / Pediatrics
New York City, New York, 10003
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Hosp of the Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Children's Hosp of New Jersey / UMDNJ - New Jersey Med Schl
Newark, New Jersey, 071072198
United States
Univ of Massachusetts Med Ctr
Worcester, Massachusetts, 01655
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Cornell Univ Med College
New York City, New York, 10021
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405
United States
Additional Information:
Study ID Numbers: ACTG 076;
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000960
Other Pregnancy Studies:
1. A Phase II Safety and Efficacy Study of Clarithromycin in the Treatment of Disseminated M. avium Complex (MAC) Infections in Patients With AIDS
2. A Study of Immune System Activity in Healthy Adults
3. Comparison of Three Treatments for Pneumocystis Pneumonia in AIDS Patients
4. Treatment Success and Failure in HIV-Infected Subjects Receiving Indinavir in Combination with Nucleoside Analogs: A Rollover Study for ACTG 320
5. A Study of Dideoxycytidine in HIV-Infected Patients
Related Studies:
Other Pregnancy Clinical Trials
Other Clinical Trials
Other San Juan Clinical Trials
The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants
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