Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT01801618
Status:
COMPLETED
Last Update Posted:
2016-07-21
First Post:
2013-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
National Evaluation of PI-based 2nd Line Efficacy in Cambodia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma HIV RNA and cDNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15001351}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-20', 'studyFirstSubmitDate': '2013-02-22', 'studyFirstSubmitQcDate': '2013-02-28', 'lastUpdatePostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of virological failure', 'timeFrame': 'at month 4', 'description': 'Virological failure is defined as an HIV viral load above 250 copies/mL'}, {'measure': 'Prevalence of drug resistance', 'timeFrame': 'at inclusion', 'description': 'Sequencing of reverse transcriptase (RT), protease (PR) and integrase (IN) HIV genes.\n\nHIV drug resistance is defined by the presence of resistance associated mutations inducing resistance according to the ANRS algorithm to one or more drugs in the standard second line regimen(s) used in Cambodia.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of individual risk factors associated with treatment failure', 'timeFrame': 'at inclusion', 'description': 'Individual factors will be collected at enrolment by a standardized questionnaire administered during a face to face 20 minutes interview by a trained member of the healthcare team. The questionnaire investigate adherence, perception of side effect, socio-economic status, disclosure and discrimination issues.'}, {'measure': 'Evaluation of structural risk factors associated with treatment failure', 'timeFrame': 'At study initiation', 'description': 'Structural risk factors will be collected at the beginning of the study in each participating site through a standardized questionnaire including information on episodes of ARV stock-outs, task-shifting of HIV-care from physician to nurses, availability of psychosocial support, health service provider/patient ratio and health care provider availabilities, quality control, site activities indicators. The questionaire will be filled by the site project coordinator together with the coordinating project social science team.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'PI based 2nd line ARV treatment', 'Virological failure', 'Drug resistance', 'Cambodia', 'Adherence'], 'conditions': ['HIV']}, 'descriptionModule': {'briefSummary': 'Medium and long term efficacy of PI-based 2nd line antiretroviral (ARV) therapy in Cambodia is poorly documented when the numbers of patients on treatment and their duration are increasing. For patients in treatment failure , there is no alternative ARV regimen available to date.\n\nThis operational research aims to evaluate the Cambodian National Program PI-based 2nd line antiretroviral regimen to assess the proportion of treatment failure and drug resistance ;identify the structural and individual factors associated with treatment failure ; design alternative salvage ARV regimens.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All HIV-1 infected adults receiving a PI-based 2nd line regimen in one of the 13 participating national program ARV treatment sites.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infection\n* age above 18 years\n* current PI based 2nd line ARV treatment since at least 6 months\n* willing to participate and consent signature\n\nExclusion Criteria:\n\n* ongoing PI based 2nd line regimen for less that 6 months at time of study intake'}, 'identificationModule': {'nctId': 'NCT01801618', 'briefTitle': 'National Evaluation of PI-based 2nd Line Efficacy in Cambodia', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'National Evaluation of PI-based 2nd Line Efficacy in Cambodia', 'orgStudyIdInfo': {'id': 'ANRS12276 2PICAM'}}, 'contactsLocationsModule': {'locations': [{'city': 'Battambang', 'country': 'Cambodia', 'facility': 'Battambang Hospital', 'geoPoint': {'lat': 13.10271, 'lon': 103.19822}}, {'city': 'Chey Chum Neah', 'country': 'Cambodia', 'facility': 'Chey Chum Neah Hospital'}, {'city': 'Daun Keo', 'country': 'Cambodia', 'facility': 'Daun Keo Hospital'}, {'city': 'Kampong Cham', 'country': 'Cambodia', 'facility': 'Kampong Cham Hospital', 'geoPoint': {'lat': 11.99339, 'lon': 105.4635}}, {'city': 'Neak Loeung', 'country': 'Cambodia', 'facility': 'Neak Loeung Hospital'}, {'city': 'Phnom Penh', 'country': 'Cambodia', 'facility': 'Calmette Hospital', 'geoPoint': {'lat': 11.56245, 'lon': 104.91601}}, {'city': 'Phnom Penh', 'country': 'Cambodia', 'facility': 'Hope Center', 'geoPoint': {'lat': 11.56245, 'lon': 104.91601}}, {'city': 'Phnom Penh', 'country': 'Cambodia', 'facility': 'Khmero-Soviet Friendship Hospital', 'geoPoint': {'lat': 11.56245, 'lon': 104.91601}}, {'city': 'Phnom Penh', 'country': 'Cambodia', 'facility': 'Preah Kossamak Hospital', 'geoPoint': {'lat': 11.56245, 'lon': 104.91601}}, {'city': 'Phnom Penh', 'country': 'Cambodia', 'facility': 'Preahketomealea Hospital', 'geoPoint': {'lat': 11.56245, 'lon': 104.91601}}, {'city': 'Phnom Penh', 'country': 'Cambodia', 'facility': 'Social Health Clinic', 'geoPoint': {'lat': 11.56245, 'lon': 104.91601}}, {'city': 'Siem Reap', 'country': 'Cambodia', 'facility': 'Siem Reap Hospital', 'geoPoint': {'lat': 13.36179, 'lon': 103.86056}}, {'city': 'Sihanoukville', 'country': 'Cambodia', 'facility': 'Sihanouk Ville Hospital', 'geoPoint': {'lat': 10.60932, 'lon': 103.52958}}], 'overallOfficials': [{'name': 'Vonthanak Saphonn, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cambodian National Center of HIV/AIDS, Dermatology and STDs (NCHADS)'}, {'name': 'Eric Nerrienet, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Institut Pasteur, Paris France'}, {'name': 'Bruno Spire, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Observatoire Régional de la Santé, Marseille, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}