- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00424814
Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-partum Phase. ANRS 135 Primeva
Prevention of HIV1 Mother to Child Transmission Without Nucleoside Analogue Reverse Transcriptase Inhibitors in the Pre-partum Phase. A Multicenter Randomised Phase II/III Open Label Study With a Group of 100 Pregnant Women Receiving Lopinavir/Ritonavir and a Group of 50 Receiving Lopinavir/Ritonavir Plus Zidovudine and Lamivudine. ANRS 135 Primeva
연구 개요
상태
정황
상세 설명
Recent data from the French perinatal cohort and others indicate that HIV-RNA levels at delivery correlate with risk of transmission among women treated with antiretroviral agents. Most of these treatments include zidovudine alone or in combination. Mitochondrial toxicity related to nucleoside analogues exposure (zidovudine and lamivudine) has been reported in adults and in infants with in utero exposure to these drugs. In addition, biological markers of genotoxicity on nuclear DNA have recently been shown in exposed newborn. These issues raised the concern of the risk/benefit of multiple therapy in the context of mother to child transmission for women who do not meet the standard criteria for antiretroviral therapy. In women with CD4≥350 and VL<30 000 copies/ml a treatment with lopinavir/ritonavir should achieve a rapid control of HIV1 viremia below 1000 copies/ml without harm in term of resistance. In this study we would like to assess under strict control, the safety and efficacy of such regimen compared to the same boosted PI + zidovudine and lamivudine as standard regimen. The treatment will start at 26 weeks of gestation, and the follow up will include safety and efficacy parameters as well as pharmacokinetics in plasma and genital tract for the women, blood/cord ratio, testing for ARV resistance. Women will stop their treatment after delivery. Infants will be closely monitored up to 24 months with HIV DNA and HIV.RNA-PCR for HIV testing and biochemical and haematology usual safety evaluation. In addition frozen samples will be collected for specific evaluation of nucleoside analogue foetal mitochondrial and nuclear DNA interactions.
In term of transmission safety, the end point would be to reach a viral load below 200 copies after 8 weeks of treatment. In case of failure, this would allow a sufficient delay for a treatment modification: i.e. addition of NRTI and an elective caesarian could be programmed.
연구 유형
등록 (실제)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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-
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Paris, 프랑스, 75013
- Hopital Pitie Salpetriere
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria: Assessed between 20 and 24 months of pregnancy
- Pregnancy known before 24 weeks of gestation
- Documented HIV-1 infection without indication for ARV therapy
- CD4 count above or equal to 350 per mm3
- VL under 30 000 copies per ml
- Naïve for PI (except treatment during previous pregnancy)
- Informed consent signed
Exclusion Criteria:
- HIV2 infection or HIV1 group O infection
- Any pathology related to pregnancy
- Contra-indication to study drugs
- Unstable hypertension or diabetes
- Known risk of premature delivery
- In case of previous treatment with a protease inhibitor : presence of resistance mutations on the HIV-1 protease gene by genotyping analysis (1 mutation among V32I et I47A, I50V V82A/F/S/T, I84V, L90 M or more than 3 mutations among L10 F/I/R/V, K20/M/R, L24I, L33F, M46I/L, F53L, I54M/L/T/V, L63P, A71L/V/T,)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 1
Kaletra (lopinavir/ritonavir)
|
(200/50 mg x2)x 2/d= 2 pills twice daily
|
활성 비교기: 2
Kaletra (lopinavir/ritonavir) + Combivir (zidovudine/lamivudine)
|
Kaletra (lopinavir/ritonavir): (200/50 mg x2)x 2/d= 2 pills twice daily Combivir (zidovudine/lamivudine): (300/150mg) x 2/d=1 pill twice daily
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Proportion of mother with plasma HIV1 below 200 copies per ml after 8 weeks of treatment
기간: W8
|
W8
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Proportion of women maintained with monotherapy until delivery,
기간: delivery
|
delivery
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Proportion of women with a VL below 50 copies per ml at delivery
기간: delivery
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delivery
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Proportion of women harbouring resistant HIV strains four weeks after delivery
기간: W4 post partum
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W4 post partum
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Concentrations of studied drug in plasma and in cord-blood
기간: at delivery
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at delivery
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HIV-1 detection and concentrations of studied drug in vaginal secretion before and after treatment
기간: W0, W8 of treatment
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W0, W8 of treatment
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concentrations of studied drugs in the new born gastric fluid, HIV diagnostic in infant (criteria for stopping the trial at second infection)
기간: birth
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birth
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Roland Tubiana, MD, AP-HP Hopital Pitie salpetriere
- 연구 의자: Josiane Warszawski, MD, INSERM - INED Unité U822 France
간행물 및 유용한 링크
일반 간행물
- Sibiude J, Le Chenadec J, Bonnet D, Tubiana R, Faye A, Dollfus C, Mandelbrot L, Delmas S, Lelong N, Khoshnood B, Warszawski J, Blanche S; French National Agency for Research on AIDS and Viral Hepatitis French Perinatal Cohort/Protease Inhibitor Monotherapy Evaluation Trial. In utero exposure to zidovudine and heart anomalies in the ANRS French perinatal cohort and the nested PRIMEVA randomized trial. Clin Infect Dis. 2015 Jul 15;61(2):270-80. doi: 10.1093/cid/civ260. Epub 2015 Apr 1.
- Tubiana R, Mandelbrot L, Le Chenadec J, Delmas S, Rouzioux C, Hirt D, Treluyer JM, Ekoukou D, Bui E, Chaix ML, Blanche S, Warszawski J; ANRS 135 PRIMEVA (Protease Inhibitor Monotherapy Evaluation) Study Group. Lopinavir/ritonavir monotherapy as a nucleoside analogue-sparing strategy to prevent HIV-1 mother-to-child transmission: the ANRS 135 PRIMEVA phase 2/3 randomized trial. Clin Infect Dis. 2013 Sep;57(6):891-902. doi: 10.1093/cid/cit390. Epub 2013 Jun 12.
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 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2006-006200-11
- ANRS 135 PRIMEVA
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. .
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