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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) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on 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) conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. 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) Clinical research trials and 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) health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including 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 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) Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a 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) clinical trial. Participants oftentimes recieve the most expert healthcare available for their 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) condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > 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 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 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)
For Condition: HIV Infections,Pregnancy
Status: No longer recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , National Institute of Allergy and Infectious Diseases (NIAID)
Synopsis: 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.
Details: 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).
Eligibility:
Study Type: Interventional, Treatment, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 13 Years/60 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria 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: - 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 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. - 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).
Total Enrollment: 1600
Location and Contact Information:
Overall Study Official:
ERStiehm, Study Chair,
Washington Hosp Ctr
Washington D.C., District of Columbia, 200102931
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, 381052794
United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Children's Hosp of Denver
Denver, Colorado, 802181088
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Case Western Reserve Univ - Pediatric
Cleveland, Ohio, 44106
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Hermann Hosp / Univ Texas Health Science Ctr
Houston, Texas, 77030
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Denver Gen Hosp
Denver, Colorado, 802044507
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
State Univ of New York at Stony Brook
Stony Brook, New York, 117948111
United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Hosp of the Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Methodist Hosp Central
Memphis, Tennessee, 381052794
United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Univ Hosp
New Orleans, Louisiana, 70112
United States
Temple Univ School of Medicine
Philadelphia, Pennsylvania, 191341095
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Thomas Jefferson Univ Hosp
Philadelphia, Pennsylvania, 191075098
United States
Additional Information:
Study ID Numbers: ACTG 185;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000751
Other Pregnancy Studies:
1. Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy
2. Intracellular Pharmacokinetics of Zidovudine Triphosphate in Maternal and Infant Cord Blood Mononuclear Cells.
3. The Safety and Effectiveness of Zidovudine in HIV-Infected Pregnant Women and Their Infants
4. Effect of Pregnancy on Uveitis
5. Quick Start Approach to Birth Control Pills
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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)
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