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A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers Clinical research trials and A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers. A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers clinical trial. Subjects typically recieve the finest healthcare available for their A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers  A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
For Condition: HIV Infections,Pregnancy
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to the mother during active labor, and when their neonates are dosed during the first week of life. To determine the short-term safety profile of mothers receiving zidovudine (AZT) who received nevirapine during active labor, and their neonates who received no dose, a single dose, or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of life. Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.
Details: Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection. Pregnant women in active labor receive single doses of oral nevirapine. The neonates of the first 4-6 (PER AMENDMENT 8/27/96, was 4) mothers receive no drug, while the neonates of the second 4-6 (PER AMENDMENT 8/27/96, was 4) patient cohort receive a single dose of nevirapine. If neonatal antiviral levels of nevirapine are not sustained for 7 days after the single dose, a third cohort of 4-6 (PER AMENDMENT 8/27/96, was 4) pregnant women will receive a single dose of nevirapine and their neonates will receive multiple doses of nevirapine to maintain an antiviral effect for 7 days.
Eligibility:
Study Type: Interventional, Treatment, Pharmacokinetics Study
Minimum Age/Maximum Age: 13 Years/60 Years
Genders: Female
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - AZT (mothers and neonates). - Oral asthma inhalers (mothers). Concurrent Treatment: Allowed: - Phototherapy (neonates). MOTHERS must have: - HIV infection. - Estimated gestational age >= 34 weeks. - No active opportunistic infection at study entry. PER AMENDMENT 8/27/96: - A pre-enrollment plasma HIV-1 RNA level greater than 10,000 copies/ml. Exclusion Criteria Co-existing Condition: MOTHERS with the following symptoms or conditions are excluded: - Intrauterine growth retardation. - Fetal anomaly incompatible with life as determined by pre-entry ultrasound. - Participation during current pregnancy in any other therapeutic or vaccine perinatal trial. - Known hypersensitivity to any benzodiazepine. - Serious bacterial infection. Concurrent Medication: Excluded: - Any antiretroviral other than AZT. - Corticosteroids (other than oral asthma inhalers). - Anticoagulants. - Any clavulanic acid-containing formulation (e.g., Augmentin, Timentin). - Benzodiazepines other than study drug. - Phenobarbital. - Barbiturates. - Antacids. - Magnesium sulfate. Prior Medication: Excluded: - Prior nevirapine. Current use of illicit substances and/or active chronic alcohol use.
Total Enrollment: 49
Location and Contact Information:
Overall Study Official:
SullivanJL, Study Chair,
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
United States
San Francisco Gen Hosp
San Francisco, California, 94110
United States
Mount Sinai Med Ctr / Pediatrics
New York City, New York, 10029
United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714
United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004
United States
Connecticut Children's Med Ctr - Pediatric
Hartford, Connecticut, 06106
United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032
United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105
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
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Additional Information:
Study ID Numbers: ACTG 250;
Study Start Date:
Record last reviewed: June 1997
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000808
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2. Dual Versus Triple Protease Inhibitor Combinations, Including Ritonavir, in HIV Infected People
3. A Phase I Study of the Safety and Pharmacokinetics of Recombinant Human CD4-Immunoglobulin G (rCD4-IgG) Administered by Intravenous Bolus Injection in Combination With Oral Zidovudine in Patients With AIDS and AIDS-Related Complex
4. Vaccine (ALVAC-HIV vCP1452) Use and Intermittent Withdrawal of Anti-HIV Drugs in Patients with HIV
5. Prospective Open-Label Study of the Emergence of Drug Resistance in Patients Infected With HIV-1 Who Are Taking Oral U-87201E
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A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
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