Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants
NCT ID: NCT00076791
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
66 participants
INTERVENTIONAL
2004-03-31
2011-03-31
Brief Summary
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Detailed Description
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Cohort 1 is now closed. Each participant in Cohort 1 received 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 received only the standard 6 weeks of oral ZDV prophylaxis postpartum. PK blood samples were taken from mothers at predose and 1, 2, 4, 8, 12, and 24 hours postdose and at the time of delivery; PK blood samples were taken from infants at 12, 24, and 36 hours after birth.
Pregnant women with HIV infection entering this study will be assigned to Cohort 2, as 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 900 mg of TDF combined with 600 mg emtricitabine, 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 combined with 3 mg/kg emtricitabine as soon as possible after delivery and within 6 hours of age 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 or FTC/TDF is demonstrated at Weeks 1, 6, or 12. In addition to the PK studies, blood collection will occur around the time of delivery, 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. Mothers are encouraged to coenroll in PACTG P1025, Pharmacokinetic Study of Anti-HIV Drugs During Pregnancy.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
Each participant in Cohort 1 received 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 received only the standard 6 weeks of oral ZDV prophylaxis postpartum.
Emtricitabine/Tenofovir disoproxil fumarate
900 mg of TDF combined with 600 mg emtricitabine
Tenofovir disoproxil fumarate
600 mg oral dose of TDF
2
Mothers in Cohort 2 will receive a single dose of 900 mg of TDF combined with 600 mg emtricitabine, 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 combined with 3 mg/kg emtricitabine as soon as possible after delivery and within 6 hours of age as well as the standard 6 weeks of oral ZDV prophylaxis after birth.
Emtricitabine/Tenofovir disoproxil fumarate
900 mg of TDF combined with 600 mg emtricitabine
Tenofovir disoproxil fumarate
600 mg oral dose of TDF
Interventions
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Emtricitabine/Tenofovir disoproxil fumarate
900 mg of TDF combined with 600 mg emtricitabine
Tenofovir disoproxil fumarate
600 mg oral dose of TDF
Eligibility Criteria
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Inclusion Criteria
* 34 weeks or more (third trimester) into pregnancy at study 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
* Active opportunistic infection and/or serious bacterial infection at time of study entry
* Certain abnormal laboratory values at study screening
* Chronic malabsorption or chronic diarrhea
* Certain medical or obstetrical complications during the current pregnancy
* Fetal abnormalities as measured by ultrasound screening performed at 18 weeks into pregnancy or later
* Intend 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
* Require certain medications
18 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Patricia M. Flynn, MD
Role: STUDY_CHAIR
Department of Infectious Disease, St. Jude's Children's Research Hospital
Arlene D. Bardeguez, MD, MPH, FACOG
Role: STUDY_CHAIR
Obstetrics, Gynecology, and Women's Health, University of Medicine and Dentistry of New Jersey
Locations
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Children's National Med. Ctr. Washington DC NICHD CRS
Washington D.C., District of Columbia, United States
Washington Hosp. Ctr. NICHD CRS
Washington D.C., District of Columbia, United States
Univ. of Miami Ped. Perinatal HIV/AIDS CRS
Miami, Florida, United States
Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
Chicago, Illinois, United States
Children's Hospital of Michigan NICHD CRS
Detroit, Michigan, United States
NJ Med. School CRS
Newark, New Jersey, United States
Nyu Ny Nichd Crs
New York, New York, United States
Bronx-Lebanon Hosp. IMPAACT CRS
The Bronx, New York, United States
Hahnemann Univ. Hosp.
Philadelphia, Pennsylvania, United States
Regional Med. Ctr. at Memphis
Memphis, Tennessee, United States
St. Jude/UTHSC CRS
Memphis, Tennessee, United States
San Juan City Hosp. PR NICHD CRS
San Juan, , Puerto Rico
Countries
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References
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Antoniou T, Park-Wyllie LY, Tseng AL. Tenofovir: a nucleotide analog for the management of human immunodeficiency virus infection. Pharmacotherapy. 2003 Jan;23(1):29-43. doi: 10.1592/phco.23.1.29.31915.
Kourtis AP, Duerr A. Prevention of perinatal HIV transmission: a review of novel strategies. Expert Opin Investig Drugs. 2003 Sep;12(9):1535-44. doi: 10.1517/13543784.12.9.1535.
Moodley J, Moodley D. Management of human immunodeficiency virus infection in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2005 Apr;19(2):169-83. doi: 10.1016/j.bpobgyn.2004.10.007. Epub 2004 Dec 15.
Abrams EJ. Prevention of mother-to-child transmission of HIV--successes, controversies and critical questions. AIDS Rev. 2004 Jul-Sep;6(3):131-43.
Thorne C, Newell ML. The safety of antiretroviral drugs in pregnancy. Expert Opin Drug Saf. 2005 Mar;4(2):323-35. doi: 10.1517/14740338.4.2.323.
Other Identifiers
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10034
Identifier Type: REGISTRY
Identifier Source: secondary_id
PACTG 394
Identifier Type: -
Identifier Source: secondary_id
IMPAACT 394
Identifier Type: -
Identifier Source: secondary_id
P394
Identifier Type: -
Identifier Source: org_study_id