Etravirine Plus 2 Analogs in HIV-infected Patients
Virological Efficacy and Safety of Etravirine Plus 2 Active Nucleos(t)Ide Reverse-transcriptase Inhibitors (NRTIs) in HIV-1-infected Patients
연구 개요
상태
정황
상세 설명
Methods: prospective, single arm multicenter clinical trial without entry restrictions on plasma HIV-RNA (VL) or CD4 with a planned duration of 52 weeks.
The primary clinical endpoint is the percentage of subjects with therapeutic success on etravirine 400 mg/day (200 mg bid or 400 mg qd) plus 2 active NRTIs after 12 months. Efficacy data will be analyzed by on-treatment and by intention-to-treat analyses (noncomplete/missing equals failure), considering treatment failure as either treatment interruption whatever the reason (adverse events, death, or loss to follow-up) or virological failure, defined as inability to suppress the VL to less than 50 copies/ml after 24 weeks on treatment or a confirmed VL of more than 200 copies/ml in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion.
Patients missing two consecutive scheduled visits were considered lost to follow-up. The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
NRTIs prescribed as part of HAART were selected by the responsible physicians on the basis of previous antiretroviral treatments and/or genotypic resistance testing.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Cordoba, 스페인, 14004
- Hospital Universitario Reina Sofia
-
Granada, 스페인, 18014
- Hospital Universitario Virgen de las Nieves
-
Granada, 스페인, 04009
- Hospital Universitario San Cecilio
-
Jaen, 스페인, 23001
- Hospital Ciudad de Jaén
-
Malaga, 스페인, 29010
- Hospital Universitario Virgen de la Victoria
-
Malaga, 스페인, 29010
- Hospital Universitario Carlos Haya
-
Sevilla, 스페인, 41013
- Hospital Universitario Virgen del Rocio
-
Sevilla, 스페인, 41014
- Hospital Universitario Virgen de Valme
-
-
Cadiz
-
La Linea de la Concepción, Cadiz, 스페인, 11300
- Hospital La Linea de la Concepción
-
Puerto Real, Cadiz, 스페인, 11510
- Hospital Universitario Puerto Real
-
-
Malaga
-
Marbella, Malaga, 스페인, 29600
- Hospital Costa Del Sol
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Older than 18 years, starting an antiretroviral regimen based on etravirine plus 2 NRTIs between January 2009 and June 2010, evidence of activity of all drugs on the basis of treatment history and genotypic resistance testing, informed consent, and at least one follow-up visit.
Exclusion Criteria:
- Genotypic resistance tests with evidence of resistance to any drug used, and concomitant use of drugs with potentially adverse interactions with etravirine pharmacokinetics, such as rifampin.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
etravirine
Antiretroviral regimens based on etravirine plus 2 active nucleos(t)ide reverse-transcriptase inhibitors (NRTIs)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Virological efficacy
기간: 52 weeks
|
Percentage of subjects with therapeutic success at month 12. Efficacy data will be analyzed by on-treatment and by intention-to-treat considering treatment failure as either treatment interruption whatever the reason (adverse events, death, or loss to follow-up) or virological failure, defined as inability to suppress the VL to <50 copies/ml after 24 weeks or a confirmed VL of >200 copies/ml in patients who had previously achieved a viral suppression or had an undetectable viral load at inclusion.
Patients missing two consecutive scheduled visits were considered lost to follow-up.
|
52 weeks
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Safety
기간: 52 weeks
|
The safety and tolerability of the studied medications will be evaluated by means of clinical adverse events, physical examination and laboratory results.
|
52 weeks
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Luis F Lopez-Cortes, MD, PhD., Hospitales Universitarios Virgen del Rocío
- 수석 연구원: Francisco Tellez-Perez, MD, Hospital de la Línea de la Concepción
- 수석 연구원: Antonio Vergara-Campos, MD, PhD., Hospital Universitario de Puerto Real
- 수석 연구원: Milagros Garcia-Lazaro, MD, Hospital Universitario Reina Sofia de Cordoba
- 수석 연구원: Jose Hernandez-Quero, MD, PhD., Hospital Universitario San Cecilio
- 수석 연구원: Juan Pascuau-Liaño, MD, PhD., University Hospital Virgen de las Nieves
- 수석 연구원: Miguel A Lopez-Ruz, MD, PhD, University Hospital Virgen de las Nieves
- 수석 연구원: Mohamed O Mohamed-Balghata, MD, Hospital Universitario Ciudad de Jaen
- 수석 연구원: Dr.Javier de la Torre-Lima, MD, PhD, Hospital Costa Del Sol
- 수석 연구원: Manuel Marquez Solero, MD, Hospital Universitario Virgen de la Victoria
- 수석 연구원: Marcial delgado, MD, Hospital Universitario Carlos Haya
- 수석 연구원: Fernando Lozano-León, MD, PhD., Hospital Universitario de Valme
간행물 및 유용한 링크
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
- LFL-ETR-2010-01
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-1 감염에 대한 임상 시험
-
Thomas Aagaard RasmussenAarhus University Hospital; The Alfred; Germans Trias i Pujol Hospital; Walter and Eliza Hall...모병
-
University of North Carolina, Chapel Hill아직 모집하지 않음
-
Craig Cohen, MD, MPHNational Institute of Allergy and Infectious Diseases (NIAID); Duke University; Osel, Inc.; DFNet Research Inc...모병
-
Gilead Sciences아직 모집하지 않음
-
International Maternal Pediatric Adolescent AIDS...National Institute of Allergy and Infectious Diseases (NIAID); Eunice Kennedy Shriver National... 그리고 다른 협력자들아직 모집하지 않음
-
Fundación HuéspedViiV Healthcare아직 모집하지 않음
-
Fundación HuéspedMSD Pharmaceuticals LLC; Fundacion IDEAA아직 모집하지 않음
-
Fondazione Policlinico Universitario Agostino Gemelli...아직 모집하지 않음