- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00076791
Safety of Tenofovir Disoproxil Fumarate (TDF) and Emtricitabine/TDF in HIV Infected Pregnant Women and Their Infants
A Phase I Study of the Safety, Tolerance, and Pharmacokinetics of Tenofovir Disoproxil Fumarate (TDF) and the Combination of TDF Plus Emtricitabine in HIV-1 Infected Pregnant Women and Their Infants
연구 개요
상태
정황
상세 설명
The majority of perinatally infected infants are infected during the labor and delivery process, but recent studies suggest that additional factors, such as postexposure 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. FTC/TDF is a combination of two NRTIs being studied because this combination has the potential to prevent MTCT, while protecting the mother from developing resistance that may develop with single drug therapy. This study will evaluate the safety, tolerance, and pharmacokinetics (PK) of single doses of TDF and FTC/TDF in both HIV infected pregnant women and their newborn infants.
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.
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
-
-
District of Columbia
-
Washington, District of Columbia, 미국, 20010
- Children's National Med. Ctr. Washington DC NICHD CRS
-
Washington, District of Columbia, 미국, 20010
- Washington Hosp. Ctr. NICHD CRS
-
-
Florida
-
Miami, Florida, 미국, 33136
- Univ. of Miami Ped. Perinatal HIV/AIDS CRS
-
-
Illinois
-
Chicago, Illinois, 미국, 60608
- Mt. Sinai Hosp. Med. Ctr. - Chicago, Womens & Childrens HIV Program
-
-
Michigan
-
Detroit, Michigan, 미국, 48201
- Children's Hospital of Michigan NICHD CRS
-
-
New Jersey
-
Newark, New Jersey, 미국, 07101-1709
- NJ Med. School CRS
-
-
New York
-
Bronx, New York, 미국, 10457
- Bronx-Lebanon Hosp. IMPAACT CRS
-
New York, New York, 미국, 10016
- Nyu Ny Nichd Crs
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19102-1192
- Hahnemann Univ. Hosp.
-
-
Tennessee
-
Memphis, Tennessee, 미국
- Regional Med. Ctr. at Memphis
-
Memphis, Tennessee, 미국
- St. Jude/UTHSC CRS
-
-
-
-
-
San Juan, 푸에르토 리코
- San Juan City Hosp. PR NICHD CRS
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for Mothers:
- HIV infected
- 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 for Mothers:
- Prior treatment with TDF, including coformulated drugs that contain TDF, during current pregnancy
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 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.
|
900 mg of TDF combined with 600 mg emtricitabine
600 mg oral dose of TDF
|
활성 비교기: 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.
|
900 mg of TDF combined with 600 mg emtricitabine
600 mg oral dose of TDF
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Adverse experiences with a severity of Grade 3 or 4 and adverse pregnancy outcomes that cannot be directly attributed to a cause besides study treatment
기간: Throughout study
|
Throughout study
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Maternal viral load
기간: during active labor and 24 to 48 hours, 7 days, 6 to 8 weeks, and 12 weeks postpartum
|
during active labor and 24 to 48 hours, 7 days, 6 to 8 weeks, and 12 weeks postpartum
|
viral resistance to emtricitabine/tenofovir disoproxil fumarate using bulk sequencing
기간: at Weeks 1, 6, and 12 postpartum
|
at Weeks 1, 6, and 12 postpartum
|
infant HIV DNA PCR
기간: at 24 to 48 hours, 6 to 8 weeks, 4 months, and 6 months of life
|
at 24 to 48 hours, 6 to 8 weeks, 4 months, and 6 months of life
|
공동 작업자 및 조사자
협력자
수사관
- 연구 의자: Patricia M. Flynn, MD, Department of Infectious Disease, St. Jude's Children's Research Hospital
- 연구 의자: Arlene D. Bardeguez, MD, MPH, FACOG, Obstetrics, Gynecology, and Women's Health, University of Medicine and Dentistry of New Jersey
간행물 및 유용한 링크
일반 간행물
- Abrams EJ. Prevention of mother-to-child transmission of HIV--successes, controversies and critical questions. AIDS Rev. 2004 Jul-Sep;6(3):131-43.
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- P394
- 10034 (레지스트리 식별자: DAIDS ES)
- PACTG 394
- IMPAACT 394
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
HIV 감염에 대한 임상 시험
-
Hospital Clinic of Barcelona완전한
-
CDC FoundationGilead Sciences알려지지 않은
-
University of WashingtonNational Institute of Mental Health (NIMH)모병
-
University of Minnesota빼는HIV 감염 | HIV/에이즈 | 에이즈 | 보조기구 | 에이즈/HIV 문제 | 에이즈와 감염미국
-
French National Agency for Research on AIDS and...Elizabeth Glaser Pediatric AIDS Foundation완전한파트너 HIV 테스트 | 부부 에이즈 상담 | 커플커뮤니케이션 | HIV 발병률카메룬, 도미니카 공화국, 그루지야, 인도
-
Michael HoelscherClinton Health Access Initiative Inc.; Instituto Nacional de Saúde (INS), Ministério da... 그리고 다른 협력자들모집하지 않고 적극적으로HIV, 신생아 HIV 조기 진단(EID), 현장 진료 검사(PoC)모잠비크, 탄자니아
-
Allegheny Singer Research Institute (also known...모집하지 않고 적극적으로
-
Erasmus Medical Center모집하지 않고 적극적으로
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한
-
Erasmus Medical Center모병
Emtricitabine/Tenofovir disoproxil fumarate에 대한 임상 시험
-
Children's Hospital of PhiladelphiaEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Gilead Sciences 그리고 다른 협력자들아직 모집하지 않음
-
University of WashingtonGilead Sciences; CONRAD완전한
-
Marla KellerNational Institute of Allergy and Infectious Diseases (NIAID)종료됨
-
Hospitales Universitarios Virgen del RocíoInstituto de Biomedicina de Sevilla초대로 등록간염, 바이러스, 인간 | HIV 감염 기본 | HIV 및 간염을 제외한 성병스페인
-
University Hospital, CaenMerck Sharp & Dohme LLC아직 모집하지 않음
-
Instituto de Investigación Hospital Universitario...완전한
-
Xi'an Xintong Pharmaceutical Research Co.,Ltd.모병
-
New Discovery LLC모병