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Home > "S" Clinical Trials Conditions > Safety of Tenofovir Disoproxil Fumarate (TDF) in HIV Infected Pregnant Women and Their Infants  Safety of Tenofovir Disoproxil Fumarate (TDF) in HIV Infected Pregnant Women and Their Infants
Safety of Tenofovir Disoproxil Fumarate (TDF) in HIV Infected Pregnant Women and Their Infants
For Condition: HIV Infections
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , National Institute of Child Health and Human Development (NICHD)
Synopsis: Most infants infected with HIV through mother-to-child transmission (MTCT, or perinatal transmission) become infected during labor and delivery. The purpose of this study is to test the safety and tolerability of a single dose of tenofovir disoproxil fumarate (TDF) given at the time of labor to HIV infected pregnant women and to their newborn infants.
Details: The majority of perinatally infected infants are infected during the labor and delivery process, but recent studies suggest that additional factors, such as post-exposure prophylaxis, are likely to be involved in the prevention of MTCT of HIV. It is possible that antiretroviral dosing only during labor and short-term dosing to newly born infants would be sufficiently effective to prevent MTCT of HIV. TDF is a nucleoside reverse transcriptase inhibitor that has demonstrated significant effectiveness in preventing MTCT of Simian Immunodeficiency Virus (SIV) in a primate model of HIV. This study will evaluate the safety, tolerance, and pharmacokinetics of single doses of TDF in both HIV infected pregnant women and their newborn infants. Pregnant women with HIV infection will be assigned to one of two groups in this study. Each participant in Cohort 1 will receive a single 600 mg oral dose of TDF at the start of active labor or 4 hours prior to C-section, with concurrent administration of standard intravenous zidovudine (ZDV) prophylaxis and/or other antiretrovirals prescribed by her physician. The infants from Cohort 1 will receive the standard 6 weeks of oral ZDV prophylaxis postpartum, but no TDF. Pharmacokinetic blood samples will be taken from mothers at pre-dose and 1, 2, 4, 8, 12, and 24 hours post-dose and at the time of delivery; pharmacokinetic blood samples will be taken from infants at 12, 24, and 36 hours after birth. Participants in Cohort 2 will be enrolled after all infants in Cohort 1 have completed the 6 to 8 week study visit and all Cohort 1 data have been reviewed. Mothers in Cohort 2 will receive a single dose of TDF (dose to be determined by the pharmacokinetic results of Cohort 1) along with standard ZDV prophylaxis and/or other antiretrovirals prescribed by her physician. Infants will receive a single dose of TDF at 4 mg/kg at 6 hours of age (or with timing to be determined by Cohort 1's results) as well as the standard 6 weeks of oral ZDV prophylaxis after birth. Blood samples from mothers and infants will be taken as for Cohort 1. Mothers will be followed for 12 weeks postpartum or for 2 years after giving birth if viral resistance to TDF is demonstrated at Weeks 1, 6, or 12. In addition to the pharmacokinetic blood samples taken around the time of delivery, blood samples will be taken at screening, study entry, at delivery, and after delivery at various times up to Week 12. Physical exams will be done at screening, study entry, at delivery, and after delivery at various times up to Week 8. Infants will be followed until age 2. Blood will be collected and physical exams will be done at birth and at various times up to Week 96.
Eligibility:
Study Type: Interventional, Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: Inclusion Criteria for Mothers - HIV infected - 34 weeks or more (third trimester) into pregnancy at screening - Have access to a participating AIDS clinical trial unit (ACTU) and are willing to be followed at location for the duration of the study Exclusion Criteria for Mothers - Prior treatment with tenofovir disoproxil fumarate (TDF) - Active opportunistic infection and/or serious bacterial infection at time of study entry - Abnormal blood or urine laboratory values at time of screening - Chronic malabsorption or chronic diarrhea - Certain medical or obstretrical complications during the current pregnancy - Fetal abnormalities as measured by ultrasound screening performed at 20 weeks into pregnancy or later - Intention to breastfeed - Current alcohol abuse or use of illicit substances - Participation in any other therapeutic or vaccine perinatal treatment trial during the current pregnancy, unless given permission by the protocol chairs - Use of certain medications
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
ArleneBardeguez, Study Chair, University of Medicine and Dentistry of New Jersey, Obstetrics, Gynecology, and Women's Health
State University of New York at Stony Brook *Recruiting*
Stony Brook, New York, 11794-8111
United States
Recruiting Denise Ferraro 631-444-8225
Univ. of Med. & Dentistry of NJ/Univ. Hospital *Recruiting*
Newark, New Jersey, 07101-1709
United States
Recruiting Philip Andrew 973-972-3118
Childrens Hospital of Boston *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Kirk Bertelsen 617-355-8198
Los Angeles County Medical Center/USC *Recruiting*
Los Angeles, California, 90033
United States
Recruiting Eva Operskalski 323-226-2226
San Juan City Hospital *Recruiting*
San Juan, ,
Puerto Rico
Recruiting Maria Pilar Thurin 787-765-4186
St. Jude Childrens Research Hospital. Memphis *Recruiting*
Memphis, Tennessee, 90054
United States
Recruiting Diane Tucker 323-669-2390
Womens & Childrens HIV Program *Recruiting*
Chicago, Illinois, 60608-1797
United States
Recruiting Dominika Kowalski 773-257-5717
New York University School of Medicine *Recruiting*
New York City, New York, 10016
United States
Recruiting Nagamah Deygoo 212-263-5680
Additional Information:
Study ID Numbers: PACTG 394;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00076791
Other Hiv Infections Studies:
1. ALVAC-HIV vCP1452 Alone and Combined with MN rgp120
2. A Randomized, Unblinded Trial of Zidovudine Versus ddC in the Treatment of Patients Status Post PCP Who Received Long-Term Zidovudine Therapy in Protocol ACTG 002
3. Safety and Effectiveness of Nitazoxanide for the Treatment of Cryptosporidiosis in AIDS Patients
4. Curb, Alter, Lower, or Manage Stress in HIV: CALMS-HIV
5. Comparison of Two Anti-HIV Regimens that Include One of Two Forms of Didanosine (ddI)
Related Studies:
Other HIV Infections Clinical Trials
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Other Stony Brook Clinical Trials
Safety of Tenofovir Disoproxil Fumarate (TDF) in HIV Infected Pregnant Women and Their Infants
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