Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-02-25 @ 5:49 PM
Study NCT ID:
NCT00667433
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2008-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Raltegravir as Early Therapy in African-Americans Living With HIV Study
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': 'D000068898', 'term': 'Raltegravir Potassium'}, {'id': 'D000069480', 'term': 'Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination'}, {'id': 'D000068679', 'term': 'Emtricitabine'}, {'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-01', 'studyFirstSubmitDate': '2008-04-22', 'studyFirstSubmitQcDate': '2008-04-25', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess Raltegravir tolerability, acceptability, and adherence among African-American men and women initiating HIV therapy. 2. Determine the pharmacokinetics of Raltegravir in African-American men and women.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Determine the pharmacokinetics of Raltegravir in African-American men and women.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HIV', 'African American', 'treatment naïve'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'pmid': '17721395', 'type': 'BACKGROUND', 'citation': 'Markowitz M, Nguyen BY, Gotuzzo E, Mendo F, Ratanasuwan W, Kovacs C, Prada G, Morales-Ramirez JO, Crumpacker CS, Isaacs RD, Gilde LR, Wan H, Miller MD, Wenning LA, Teppler H; Protocol 004 Part II Study Team. Rapid and durable antiretroviral effect of the HIV-1 Integrase inhibitor raltegravir as part of combination therapy in treatment-naive patients with HIV-1 infection: results of a 48-week controlled study. J Acquir Immune Defic Syndr. 2007 Oct 1;46(2):125-33. doi: 10.1097/QAI.0b013e318157131c.'}]}, 'descriptionModule': {'briefSummary': 'This is a single arm, longitudinal study to examine the safety, tolerability, and pharmacokinetic and metabolic characteristics of Raltegravir among 40 African-American, HIV-infected, patients.', 'detailedDescription': 'Purpose: This study will be a single arm, prospective cohort study to examine the safety, efficacy, and pharmacokinetic and metabolic characteristics of Raltegravir in African-American men and women.\n\nParticipants: 40 HIV positive, ARV treatment-naive, African-American women and men (estimated to be 70% men, 30% women)\n\nProcedures (methods): Subjects will receive Raltegravir 400 mg BID along with Truvada for 104 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV-1 infection documented by HIV serology or detectable viral load\n* Self-described as African-American\n* Less than 7 days cumulative of prior HIV therapy\n* Plasma HIV RNA PCR equal to or greater than 1000 copies/mL within 90 days prior to study entry\n* Able to provide informed consent\n* In the opinion of the investigator, able to comply with study medication and procedures\n* ALT (SGPT) \\< or equal to 3.0 x ULN within 45 days prior to study entry\n* GRF \\> 59 as calculated by MDRD within 45 days prior to study entry\n* All women of reproductive potential (who have not reached menopause or undergone hysterectomy, bilateral oophorectomy, or tubal ligation) must have a negative serum or urine β-HCG pregnancy test performed within 48 hours before entry.\n\nAll study volunteers must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) and, if participating in sexual activity that could lead to pregnancy, the female study volunteer/male partner must use at least one reliable method of contraception (e.g., condoms, with or without a spermicidal agent; a diaphragm or cervical cap with spermicide; an IUD; or hormonal-based contraception), simultaneously while receiving the protocol-specified medication(s) and for 6 weeks after stopping the medication(s). If oral birth control pills, hormone patches, or hormone injections are used for contraception, then a second method of contraception must be used.\n\nExclusion Criteria:\n\n* Pregnancy\n* Breastfeeding\n* Prior receipt of Raltegravir\n* Any condition which in the opinion of the investigator is likely to interfere with follow-up or ability to take the study medication appropriately'}, 'identificationModule': {'nctId': 'NCT00667433', 'acronym': 'REAL', 'briefTitle': 'Raltegravir as Early Therapy in African-Americans Living With HIV Study', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'CID 0706 - Safety, Tolerability, Pharmacokinetic, and Metabolic Features of Raltegravir Among African-American Men and Women With HIV Infection', 'orgStudyIdInfo': {'id': 'CID 0706'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Single Arm', 'description': 'Single arm where subjects will receive Raltegravir 400 mg BID along with Truvada once a day for 104 weeks', 'interventionNames': ['Drug: Raltegravir + Truvada']}], 'interventions': [{'name': 'Raltegravir + Truvada', 'type': 'DRUG', 'otherNames': ['MK-0518; Isentress', 'emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg'], 'description': 'Raltegravir 400 mg tablet BID PO X 104 weeks; Truvada 200/300 mg tablet once a day PO x 104 weeks', 'armGroupLabels': ['Single Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599-7215', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Health Sciences', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'David A Wohl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David A Wohl, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'David A Wohl, MD', 'investigatorAffiliation': 'University of North Carolina, Chapel Hill'}}}}