Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-01 @ 11:49 PM
Study NCT ID:
NCT00100568
Status:
COMPLETED
Last Update Posted:
2013-09-06
First Post:
2005-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected Adults in Senegal
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': 'C098320', 'term': 'efavirenz'}, {'id': 'C109078', 'term': 'lamivudine, zidovudine drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-04', 'studyFirstSubmitDate': '2005-01-03', 'studyFirstSubmitQcDate': '2005-01-03', 'lastUpdatePostDateStruct': {'date': '2013-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Virologic efficacy, defined as HIV-1 viral load less than 200 copies/ml', 'timeFrame': 'Through Week 24'}, {'measure': 'Treatment-related toxicity of Grade 3 or higher as measured by development of drug-related toxicities severe enough to warrant dose modification, interruption, or permanent discontinuation', 'timeFrame': 'Through Week 24'}], 'secondaryOutcomes': [{'measure': 'Virologic efficacy', 'timeFrame': 'At Weeks 48 and 96'}, {'measure': 'Treatment related toxicity', 'timeFrame': 'At Weeks 48 and 96'}, {'measure': 'Virologic failure, defined as HIV-1 viral load greater than 1,000 copies/ml', 'timeFrame': 'Throughout study'}, {'measure': 'CD4 counts and HIV-1 RNA viral load', 'timeFrame': 'Throughout study'}, {'measure': 'First new or recurrent AIDS-defining event (as defined by the CDC Expanded AIDS Surveillance Case definition) or death', 'timeFrame': 'Throughout study'}, {'measure': 'Treatment discontinuation, defined as premature discontinuation of participation in the study, failure to take ARV therapy for 8 or more consecutive weeks, or to switch to another ARV regimen for any reason during the full course of the study', 'timeFrame': 'Throughout study'}, {'measure': 'Genotypic resistance measured by at least 1 genotypic mutation associated with resistance among subjects with a confirmed virologic failure (as described previously) and evaluation of genotypic drug resistance patterns', 'timeFrame': 'At Weeks 24 and 96'}, {'measure': 'Treatment adherence, defined by 95% or greater of prescribed pills taken', 'timeFrame': 'Throughout study'}, {'measure': 'Quality of life as measured by items and patterns of responses to the FAHI questionnaire', 'timeFrame': 'Throughout study'}, {'measure': 'HIV-1 DNA and RNA measurements', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'keywords': ['Treatment Naive'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '10449294', 'type': 'BACKGROUND', 'citation': "Meda N, Ndoye I, M'Boup S, Wade A, Ndiaye S, Niang C, Sarr F, Diop I, Carael M. Low and stable HIV infection rates in Senegal: natural course of the epidemic or evidence for success of prevention? AIDS. 1999 Jul 30;13(11):1397-405. doi: 10.1097/00002030-199907300-00018."}, {'pmid': '15472858', 'type': 'BACKGROUND', 'citation': 'DeJesus E, Herrera G, Teofilo E, Gerstoft J, Buendia CB, Brand JD, Brothers CH, Hernandez J, Castillo SA, Bonny T, Lanier ER, Scott TR; CNA30024 Study Team. Abacavir versus zidovudine combined with lamivudine and efavirenz, for the treatment of antiretroviral-naive HIV-infected adults. Clin Infect Dis. 2004 Oct 1;39(7):1038-46. doi: 10.1086/424009. Epub 2004 Sep 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the safety and effectiveness of the anti-HIV drugs efavirenz and lamivudine/zidovudine given to treatment-naive HIV-infected people in Dakar, Senegal.', 'detailedDescription': 'Despite a relatively low prevalence of HIV infection, all HIV subtypes have been documented in Senegal. Data on mutations that confer resistance to antiretroviral (ARV) drugs are limited to HIV subtype B; adherence data are also limited. The study will evaluate the safety and efficacy of an ARV regimen given to treatment-naive HIV infected adults and adolescents. The study will also examine the characteristics of virologic failure and adherence in this treatment group. Participants will be recruited at two sites in Dakar, Senegal.\n\nThis study will last 96 weeks. At study entry, all participants will be given an ARV regimen of lamivudine/zidovudine twice daily and efavirenz once daily. If toxicity or treatment failure occurs, some participants may require changes in their ARV regimens. There will be 14 study visits during the study; a physical exam, blood collection, and sociodemographic and medication history assessments will occur at each visit. Participants will also be asked to complete quality-of-life and adherence questionnaires. An off-study visit will occur at approximately one month after Week 96, with assessments and procedures similar to visits during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-infected\n* Have never taken ARV drugs\n* CD4 count of 200 cells/mm3 or less within 30 days of study entry if asymptomatic OR CD4 count of 350 cells/mm3 or less within 60 days of study entry if CDC Category A or B clinical condition present OR clinical diagnosis of AIDS, regardless of CD4 count\n* Willing to stay in the study area for the duration of the study\n* Willing to use acceptable forms of contraception\n\nExclusion Criteria:\n\n* HIV-2 infected\n* Systemic chemotherapy (except interferon) within 6 months prior to study entry\n* Current drug or alcohol abuse that, in the opinion of the investigator, may interfere with the study\n* Serious illness, including any active AIDS-defining infection, active tuberculosis, malaria, or any illness requiring systemic treatment or hospitalization. People who have completed therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.\n* Serious psychiatric problems within 60 days of study entry, including depression, suicidal thoughts or attempts, aggressive behavior, or psychosis-like symptoms\n* Have taken certain medications within 30 days of study entry\n* Pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00100568', 'briefTitle': 'Efavirenz and Lamivudine/Zidovudine for Treatment-Naive HIV Infected Adults in Senegal', 'nctIdAliases': ['NCT00738465'], 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Pilot Study of Safety, Effectiveness, and Adherence of Lamivudine/Zidovudine and Efavirenz (3TC/ZDV + EFV) to Treat HIV-1 Infection in Senegal', 'orgStudyIdInfo': {'id': 'CIPRA-SN-001'}, 'secondaryIdInfos': [{'id': 'SN-CIPRA-001'}, {'id': '10412', 'type': 'REGISTRY', 'domain': 'DAIDS-ES'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'All participants will be given an ARV regimen of lamivudine/zidovudine and efavirenz at study entry. If toxicity or treatment failure occurs, some participants may require changes in their ARV regimens.', 'interventionNames': ['Drug: Efavirenz', 'Drug: Lamivudine/zidovudine']}], 'interventions': [{'name': 'Efavirenz', 'type': 'DRUG', 'otherNames': ['EFV'], 'description': '600 mg tablet taken orally daily', 'armGroupLabels': ['1']}, {'name': 'Lamivudine/zidovudine', 'type': 'DRUG', 'otherNames': ['3TC/ZDV'], 'description': '150mg lamivudine/300mg zidovudine tablet taken orally twice daily', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Dakar', 'country': 'Senegal', 'facility': 'Centre National Hospitalier de Fann, Dakar CIPRA CRS', 'geoPoint': {'lat': 14.6937, 'lon': -17.44406}}, {'city': 'Dakar', 'country': 'Senegal', 'facility': "Institut d'Hygiène Sociale, Dakar CIPRA CRS", 'geoPoint': {'lat': 14.6937, 'lon': -17.44406}}], 'overallOfficials': [{'name': 'Souleymane Mboup, PharmD', 'role': 'STUDY_CHAIR', 'affiliation': 'Laboratoire de Bacteriologic et de Virologie, Hospital Le Dantec Avenue Pasteur'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': "Initiative Senegalaise d'Acces aux Antiretroviraux (ISAARV)", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}