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A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants Clinical research trials and A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants medical trials take place in many of places 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants. A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants clinical trial. Test subjects typically obtain the finest healthcare available for their A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants  A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants
A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants
For Condition: HIV Infections,Pregnancy
Status: No longer recruiting
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 infants can help reduce the chance that a mother will give HIV to her baby during delivery. NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their infants. NVP is inexpensive and is easily absorbed by the mother and transferred to the infant. It is thought that even a single dose to the mother and infant may provide enough protection to the baby during the time of exposure to HIV at birth.
Details: NVP 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 suggests that NVP would be rapidly absorbed by the mother and transferred to the infant in utero when given during labor and delivery. The HIV-1 antiviral activity is rapid with significant reduction in plasma virus occurring within a few days of drug administration. In addition, NVP 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 NVP suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of NVP may provide a prophylactic level of NVP in the infant during the time of exposure to virus in the birth canal and/or in the maternal blood. In addition, NVP may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk. Mothers are randomized to receive either a single oral dose of NVP during labor or the corresponding NVP placebo. Randomization occurs at any time after the 28th week of gestation. To assure balance between the treatment groups, the randomization is stratified using 2 factors: (1) antiretroviral therapy during the current pregnancy (no antiretroviral therapy at all, monotherapy [with no multi-agent therapy] for any duration, or multi-agent therapy for any duration), and (2) CD4 cell count at the time of randomization (less than 200 cells, 200 to 399 cells, or 400 cells or greater). Mothers are followed on-study for 4 to 6 weeks postpartum. All mothers are required to incorporate zidovudine (ZDV) into their current treatment regimen and should continue ZDV during delivery and give ZDV to their infants as recommended. ZDV will not be provided as part of the study. Infants receive a single oral dose of NVP (or the corresponding placebo) administered 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 study drug according to their randomization group regardless of whether the mother received study drug or not. Infants are followed for 6 months of life and are tested for HIV at birth, 4 to 6 weeks of life, 3 months of life, and 6 months of life.
Eligibility:
Study Type: Interventional, Prevention, Double-Blind, Efficacy Study
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria You may be eligible for this study if you: - Are an HIV-positive pregnant woman. - Have been pregnant for at least 28 weeks. - Are at least 13 years of age (consent of parent or guardian is required if under 18). Exclusion Criteria You will not be eligible for this study if: - You intend to breast-feed. - You are allergic to benzodiazepines (a type of tranquilizer). - You have a liver disorder. - You have received nonnucleoside reverse transcriptase inhibitors (NNRTIs), a class of anti-HIV drugs. - You refuse to take ZDV.
Total Enrollment: 1244
Location and Contact Information:
Overall Study Official:
DorenbaumA, Study Chair,
Texas Children's Hosp / Baylor Univ
Houston, Texas, 77030
United States
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, 35233
United States
Duke Univ Med Ctr
Durham, North Carolina, 277103499
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Univ of Miami (Pediatric)
Miami, Florida, 33161
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, 191044318
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
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
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, 200102916
United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , 009365067
Puerto Rico
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
Additional Information:
Study ID Numbers: ACTG 316B;
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001135
Other Pregnancy Studies:
1. Combination Treatment With and Without Protease Inhibitors for Women Who Begin Therapy for HIV Infection During Pregnancy
2. Oral Manifestations of Human Immunodeficiency Virus Infection in High Risk Groups
3. A Study of Itraconazole in the Treatment and Prevention of Histoplasmosis, a Fungal Infection, in Patients with AIDS
4. A Study of Rifabutin, Used Alone or with Ethambutol in the Prevention of Mycobacterium avium Complex (MAC) Bacteremia in Patients with AIDS
5. A Randomized Trial of the Efficacy and Safety of a Strategy of Starting with Nelfinavir Versus Ritonavir Added to Background Antiretroviral (AR) Nucleoside Therapy in HIV-Infected Individuals with CD4+ Cell Counts Less than or Equal to 200/mm3
Related Studies:
Other Pregnancy Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
A Study of Nevirapine to Prevent HIV Transmission from Mothers to Their Infants
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