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A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies Clinical research trials and A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies. A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies clinical trial. Test subjects typically receive the most expert healthcare available for their A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies  A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies
A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies
For Condition: HIV Infections,Pregnancy
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their babies can help reduce the chance that a mother will give HIV to her baby during delivery. This study will also test the safety of the drug and see how well it is tolerated by the mother and her baby. Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies.
Details: Nevirapine has several properties that make it an attractive candidate for antiretroviral therapy to interrupt HIV-1 transmission in the intrapartum and early postpartum period. The pharmacokinetic profile suggested that nevirapine would be rapidly absorbed and transferred to the infant in utero when given during labor and delivery. In addition, nevirapine has been shown to penetrate cell-free virions and inactivate virion-associated reverse transcriptase (RT) in situ. This property would be potentially useful in inactivating cell-free virions in the genital tract as well as in breast milk. These characteristics of nevirapine suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of nevirapine may provide a prophylactic level of nevirapine in the infant during the time of exposure to virus in the birth canal and/or maternal blood. In addition, nevirapine may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk. Women are randomized to receive either NVP or the corresponding placebo in active labor. Women are randomized at any time after their 32nd week gestation [AS PER AMENDMENT 1/13/98: 28th week gestation] [AS PER AMENDMENT 2/23/00: 20th week gestation]. The randomization is stratified using two factors: (1) use of [AS PER AMENDMENT 2/23/00: current or anticipated] antiretroviral therapy during the current pregnancy (no therapy at all; monotherapy for any duration; multi-agent therapy for any duration), and (2) CD4 cell count at the time of randomization (less than 200 cells; 200 - 399 cells; 400 cells or greater). Mothers are followed on study for 4 to 6 weeks postpartum. Mothers are also encouraged to follow the regimen of zidovudine (ZDV) outlined in the Office of Public Health and Science (PHS) treatment guidelines for both themselves and their infants. Infants are administered either NVP or placebo between 48 and 72 hours of life. The infant's study drug is the same as the mother's randomized treatment assignment. Infants are dosed with the study drug according to their randomization group regardless of whether the mother received the study drug. Infants are followed for 4 to 6 weeks, and are tested for HIV at 4 to 6 weeks, 3 months, and 6 months.
Eligibility:
Study Type: Interventional, Treatment, Double-Blind, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Women may be eligible for this study if they: - Are HIV-positive. - Are at least 20 weeks pregnant. (This study has been changed. Women no longer have to be 28 weeks pregnant.) - Have consent from the child's father (if available). - Are at least 13 years old (consent of parent or guardian required if under 18). Exclusion Criteria Women will not be eligible for this study if they: - Have ever taken NNRTIs (nonnucleoside reverse transcriptase inhibitors). - Are enrolled in another pregnancy treatment study. - Are allergic to benzodiazepines. - Have liver disease. - Plan to breast-feed.
Total Enrollment: 2009
Location and Contact Information:
Overall Study Official:
AlejandroDorenbaum, Study Chair,
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Univ Hosp
New Orleans, Louisiana, 70112
United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, 372322581
United States
Med College of Virginia
Richmond, Virginia, 23219
United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamon, , 00956
Puerto Rico
Long Beach Memorial (Pediatric)
Long Beach, California, 90801
United States
Connecticut Children's Med Ctr
Farmington, Connecticut, 060303805
United States
Brigham and Women's Hosp
Boston, Massachusetts, 02115
United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, 33136
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, 089030019
United States
Methodist Hosp Central
Memphis, Tennessee, 381052794
United States
Washington Hosp Ctr
Washington D.C., District of Columbia, 200102931
United States
Regional Med Ctr at Memphis
Memphis, Tennessee, 38103
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
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, 60612
United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, 39213
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
St Peter's Med Ctr
New Brunswick, New Jersey, 08903
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
North Broward Hosp District
Ft. Lauderdale, Florida, 33311
United States
The Med Ctr Inc
Columbus, Georgia, 31901
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
Senetara Norfolk Gen Hosp
Norfolk, Virginia, 23507
United States
Metropolitan Hosp Ctr
New York City, New York, 10029
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Hosp of the Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Univ of South Alabama
Mobile, Alabama, 36604
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Children's Med Ctr of Dallas
Dallas, Texas, 75235
United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
North Shore Univ Hosp
Great Neck, New York, 11021
United States
Children's Hosp at Albany Med Ctr
Albany, New York, 12208
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Temple Univ School of Medicine
Philadelphia, Pennsylvania, 191341095
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Bellevue Hosp / New York Univ Med Ctr
New York City, New York, 10016
United States
Tulane Univ Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, 13210
United States
Univ of Rochester Med Ctr
Rochester, New York, 146420001
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
Camden, New Jersey, 08103
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Tacoma Gen Hosp
Tacoma, Washington, 98405
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of Florida Gainesville
Gainesville, Florida, 32610
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, 23507
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
Bronx, New York, 10461
United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, 07103
United States
Med College of Georgia
Augusta, Georgia, 30912
United States
Additional Information:
Study ID Numbers: ACTG 316;
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000869
Other Pregnancy Studies:
1. A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
2. Active Immunization of HIV-Infected Pregnant Women: A Phase I Study of Safety and Immunogenicity of a rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)
3. Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated with Zidovudine
4. Prenatal Testing: Amniocentesis Versus Transabdominal Chorionic Villus Sampling (TA CVS)
5. 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)
Related Studies:
Other Pregnancy Clinical Trials
Other Mississippi Clinical Trials
Other Jackson Clinical Trials
A Study of Nevirapine for the Prevention of HIV Transmission from Mothers to Their Babies
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