Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-01-11 @ 12:38 PM
Study NCT ID:
NCT02588820
Status:
UNKNOWN
Last Update Posted:
2016-08-17
First Post:
2015-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-16', 'studyFirstSubmitDate': '2015-10-20', 'studyFirstSubmitQcDate': '2015-10-26', 'lastUpdatePostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional cure (Proportion of patients with undetectable viral reservoir)', 'timeFrame': '12 months of treatment', 'description': 'Proportion of patients in both groups with undetectable viral reservoir in peripheral and rectal tissue CD4+ T cells. A viral load will be performed at 1, 3 and 12 months after ART initiation and in rectal tissue at one year post-ART initiation.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with undetectable plasmatic HIV viral load', 'timeFrame': '1, 3 and 12 months post-stop antiretroviral treatment will be evaluated.', 'description': 'In those patients with undetectable viral reservoir stopping antiretroviral treatment at 12 months'}, {'measure': 'Level of reduction of viral reservoir among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V', 'timeFrame': '1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop'}, {'measure': 'Level of reduction of bacterial translocation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V', 'timeFrame': '1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop'}, {'measure': 'Level of reduction of immune activation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V', 'timeFrame': '1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop'}, {'measure': 'Level of reduction of inflammation among patients treated in phase I-II Fiebig and patients treated in Fiebig stage III-V', 'timeFrame': '1, 3, 12 months will be measured in patients on antiretroviral treatment and at 1, 3, 12 months post-stop'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['HIV'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Pilot study to evaluate the impact of extremely early ART in the dynamics of viral reservoir, immune activation and inflammation in patients with HIV-1 infection of less than 20 days (Fiebig stages I-II) compared to patients with infection of 20-100 days (Fiebig stages III-V), to induce HIV functional cure.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men who have sex with men\n* Male's between18 and 65 years old\n* Less than 100 days of infection\n* Patient stage Fiebig I to V\n* Negative or Incomplete western blot with negative p31 band\n\nExclusion Criteria:\n\n* P31 positive band in western blot\n* Positive Delta32 CCR5 mutation, HLA-B5701 or HLA-B27 (´late' exclusion criteria)\n* Active oncological disease\n* Active hepatitis C virus infection"}, 'identificationModule': {'nctId': 'NCT02588820', 'acronym': 'VIRECURE', 'briefTitle': 'Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Impact of Extremely Early Antiretroviral Therapy to Reduce VIral REservoir and Induce Functional CURE of HIV-1 Infection: A Pilot Comparative Study', 'orgStudyIdInfo': {'id': '2015-000251-24'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antiretroviral treatment', 'interventionNames': ['Drug: Antiretroviral Therapy (Experimental)']}], 'interventions': [{'name': 'Antiretroviral Therapy (Experimental)', 'type': 'DRUG', 'description': '1. Initial ART until HLA-B5701 results became available (48 hours):\n\n 1. Tenofovir 245 mg once a day\n 2. Emtricitabine 200 mg once a day\n 3. Dolutegravir 50 mg once a day\n 4. Darunavir 800 mg once a day\n 5. Ritonavir 100 mg once a day\n 6. Maraviroc 150 mg twice a day\n2. Three months continuation treatment (after HLA-B5701 confirmed as negative):\n\n 1. Dolutegravir 50 mg once a day.\n 2. Abacavir 600 mg once a day\n 3. Lamivudine 300 mg once a day\n 4. Darunavir 800 mg once a day\n 5. Ritonavir 100 mg once a day\n 6. Maraviroc 150 mg twice a day The whole treatment schedule comprises 7 pills per day (in a single dose), except for maraviroc, which will be given twice daily.\n3. Nine months continuation treatment (till complete 12 months treatment):\n\n 1. Abacavir, 600mg once a day\n 2. Lamivudine, 300 mg once a day\n 3. Dolutegravir, 50 mg once a day', 'armGroupLabels': ['Antiretroviral treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Josep Maria Miró, MD', 'role': 'CONTACT', 'phone': '+34 337 54 00'}], 'facility': 'Hospital Clínic i Provincial de Barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Garcia Cinca', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Research Manager', 'investigatorFullName': 'David Garcia Cinca', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}