Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-24 @ 4:14 AM
Study NCT ID:
NCT00158457
Status:
COMPLETED
Last Update Posted:
2007-07-03
First Post:
2005-09-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'C075889', 'term': 'Racivir'}, {'id': 'C098320', 'term': 'efavirenz'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-07-02', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2007-07-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the antiretroviral efficacy as first line treatment assessed as percentage of patients with viral load below 400 copies/ml at week 48 in the intention to treat (ITT) population', 'timeFrame': 'S48'}], 'secondaryOutcomes': [{'measure': 'Reduction of the viral load and percentage of patients with a viral load lower than 50 copies/ml', 'timeFrame': 'S24 and S96'}, {'measure': 'Viral load evolution', 'timeFrame': 'S24 and S48'}, {'measure': 'Genotype resistance profile evaluation failing patients', 'timeFrame': 'S24, S48, S96'}, {'measure': 'Immune benefits of the combination'}, {'measure': 'Plasma concentrations of FTC, TDF and EFV', 'timeFrame': 'S4'}, {'measure': 'Adverse events clinic and lipids'}, {'measure': 'Compliance', 'timeFrame': 'S48 and S96'}]}, 'conditionsModule': {'keywords': ['Simplification regimen', 'HIV infection', 'Once a day', 'Naive patients', 'Sub-saharian Africa', 'Treatment Naive'], 'conditions': ['HIV Infection']}, 'descriptionModule': {'briefSummary': 'In the context of Sub-saharian Africa, this trial evaluate one of the most simple treatment available for HIV-1 infected patients. The combination proposed is a triple antiretroviral therapy with only one intake of 3 pills per day. This combination has already been studied in the North countries.\n\nHere in Senegal, the efficacy and the compliance to treatment will be evaluated after 24, 48 and 96 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented infection with HIV-1 (ELISA- Western Blot)\n* Outpatient of masculine or feminine gender\n* In female patients any risk of pregnancy must be avoid: women at least 1 year past menopause or being confirmed sterile or having an effective contraceptive device\n* No previous treatment with antiretroviral therapy\n* CDC group C (except tuberculosis if CD4 count is over 350 /ml), CDC group B with CD4+ count under 350/ml and CDC group A with CD4 count under 200/ml.\n* Patient has provided informed written consent\n* Patient must agree not to take any concomitant medication throughout the duration of the study without first informing the investigator\n\nExclusion Criteria:\n\n* Deficiency of the patient rendering participation in the study or understanding of the information imparted difficult or even impossible\n* Patient participating in a different clinical study\n* Presence of serious or developing pathology\n* Severe liver failure (TP under 50% et bilirubinemia over 3 LSN)\n* Thrombocytopenia with platelet level under 50 000 cells /ml\n* Known severe renal pathology (creatinine clearance under 50 ml/min)\n* Clinical or biological problem corresponding to indications of grade over or equal 3 of WHO classification\n* Karnofsky under 70 percent\n* Opportunistic infections\n* Patients taking medications not recommended in the context of the protocol'}, 'identificationModule': {'nctId': 'NCT00158457', 'briefTitle': 'Simple Once Daily Triple Regimen Including Tenofovir, Emtricitabine and Efavirenz in HIV-1 Infected Patients (ANRS 1207)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'French National Agency for Research on AIDS and Viral Hepatitis'}, 'officialTitle': 'Pilot Trial to Evaluate the Efficacy and Tolerance of a Simple Once Daily Combined Regimen Including Tenofovir (TDF), Emtricitabine (FTC) and Efavirenz (EFV) in HIV-1 Infected Patients Naive to Prior Antiretroviral Treatment in Senegal', 'orgStudyIdInfo': {'id': 'ANRS 1207'}, 'secondaryIdInfos': [{'id': 'IMEA 025'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Tenofovir (TDF)', 'type': 'DRUG'}, {'name': 'Emtricitabine (FTC)', 'type': 'DRUG'}, {'name': 'Efavirenz (EFV)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dakar', 'country': 'Senegal', 'facility': 'Centre de Traitement Ambulatoire, CHU de Fann', 'geoPoint': {'lat': 14.6937, 'lon': -17.44406}}, {'city': 'Dakar', 'country': 'Senegal', 'facility': 'Service des Maladies Infectieuses, CHU de Fann', 'geoPoint': {'lat': 14.6937, 'lon': -17.44406}}], 'overallOfficials': [{'name': 'Roland Landman', 'role': 'STUDY_CHAIR', 'affiliation': 'IMEA- Hôpital Bichat Claude Bernard, France'}, {'name': 'Papa Salif Sow', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Fann, Dakar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French National Agency for Research on AIDS and Viral Hepatitis', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Gilead Sciences', 'class': 'INDUSTRY'}, {'name': "Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba", 'class': 'OTHER'}]}}}