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A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants Clinical research trials and A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants 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 evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants. A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants clinical trial. Subjects often receive the most expert healthcare possible for their A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "A" Clinical Trials Conditions > A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants  A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
For Condition: HIV Infections,Pregnancy
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: The purpose of this study is to see if giving nelfinavir (NFV) plus zidovudine (ZDV) plus lamivudine (3TC) to HIV-positive pregnant women and their babies is safe. This study will also look at how long these drugs stay in the blood. ZDV has been given to mothers in the past to reduce the chances of passing HIV on to their babies. However, better treatments are needed to further reduce these chances and to better suit the treatment needs of mothers and their children. Taking a combination of anti-HIV drugs during pregnancy may be an answer.
Details: Despite the dramatic reduction of perinatal HIV transmission by the administration of ZDV to mother and infant, new and more potent strategies are needed to further reduce perinatal transmission and better suit the diverse treatment needs of these patients. Initiation of triple antiretroviral combinations during gestation, particularly combinations that include drugs that cross the placenta such as 3TC, may be the most effective in reducing maternal virus load to its lowest levels prior to delivery. Women receive nelfinavir plus 3TC plus ZDV antepartum (Study Day 0 until onset of active labor) through postpartum (after cord clamped to 12 weeks). [AS PER AMENDMENT 10/28/97: If patient presents in active labor with less than 1 hour to delivery time, the institutional protocol for ZDV infusion during labor should be followed.] [AS PER AMENDMENT 1/26/99: For maternal dosing, one Combivir tablet bid can be substituted for the individual formulation of 3TC and ZDV. For mothers who receive Combivir during the antepartum period, Combivir is held during labor and delivery, and the separate formulations of ZDV and 3TC are used. Patients who prematurely discontinue study treatment should continue to be followed on study for the duration of the study.] Full pharmacokinetic sampling is performed 10 to 15 days after start of therapy [AS PER AMENDMENT 2/7/00: 10 to 15 days after study entry for women currently taking nelfinavir] and again 5 to 6 weeks after delivery. A maternal blood sample and cord blood sample is collected at birth for analysis of nelfinavir concentrations. Maternal HIV RNA in plasma is monitored throughout the study. Cervicovaginal secretions are collected at entry, late gestation, and postpartum to assess the presence of HIV. A single pharmacokinetics sample is collected with each cervicovaginal secretion. Serial CD4/CD8 activation markers are measured in women during gestation and postpartum. Infants receive nelfinavir plus 3TC plus ZDV beginning approximately 12 hours following birth and continuing for 6 weeks. After birth, several blood samples are collected from the infant for determination of washout kinetics of nelfinavir. Full pharmacokinetics sampling is performed 5 to 8 days post birth and 5 to 6 weeks following multiple doses. Pharmacokinetic samples are analyzed on the first six mother-infant pairs and dosing may be adjusted accordingly for the next cohort. Agouron has agreed to make nelfinavir available to all interested study participants for a period of 6 months after the study via the patient assistance program.
Eligibility:
Study Type: Interventional, Treatment, Safety Study
Minimum Age/Maximum Age: 13 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria Patients may be eligible for this study if they: - Are at least 13 years old (need consent of parent or guardian if under 18). - Are HIV-positive. - Are in the 2nd or 3rd trimester (14 to 34 weeks pregnant) and are pregnant with one or two children. - Have a normal ultrasound exam. Exclusion Criteria Patients will not be eligible for this study if they: - Cannot take ZDV or 3TC. - Have an active opportunistic (HIV-associated) or bacterial infection, or a severe medical condition. - Have severe diarrhea. - Are at risk for premature birth or pregnancy complications. - Have a family history of phenylketonuria (PKU). - Plan to breast-feed. - Abuse alcohol or drugs. - Cannot visit the same clinic for the duration of the study. - Have taken certain anti-HIV drugs.
Total Enrollment: 24
Location and Contact Information:
Overall Study Official:
YvonneBryson, Study Chair,
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033
United States
San Juan City Hosp
San Juan, , 009367344
Puerto Rico
Temple Univ School of Medicine
Philadelphia, Pennsylvania, 191341095
United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724
United States
Columbia Presbyterian Med Ctr
New York City, New York, 10032
United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, 981050371
United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, 27710
United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470
United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, 212874933
United States
Cook County Hosp
Chicago, Illinois, 60612
United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, 21201
United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, 701122699
United States
Mt Sinai Hosp Med Ctr / Dept of Pediatrics
Chicago, Illinois, 60608
United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001
United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, 32209
United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, 01199
United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118
United States
Howard Univ Hosp
Washington D.C., District of Columbia, 20060
United States
Univ Hosp
New Orleans, Louisiana, 70112
United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672
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
Med Univ of South Carolina
Charleston, South Carolina, 294253312
United States
Children's Hosp of Michigan
Detroit, Michigan, 48201
United States
Bronx Lebanon Hosp Ctr
Bronx, New York, 10457
United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752
United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, 191341095
United States
Additional Information:
Study ID Numbers: ACTG 353; PACTG 353
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000887
Other Pregnancy Studies:
1. Emergency Contraception (ECP): Reducing Unintended Pregnancies
2. Safety and Effectiveness of Ritonavir Plus Lamivudine Plus Zidovudine in HIV-Infected Pregnant Women and Their Babies
3. A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
4. Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated with Zidovudine
5. Studying Fetal Breathing Patterns
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A Study to Evaluate the Safety and Tolerance of Nelfinavir (NFV) Given with Zidovudine (ZDV) and Lamivudine (3TC) in HIV-Positive Pregnant Women and Their Infants
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