Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-01 @ 6:26 AM
Study NCT ID:
NCT03883334
Status:
UNKNOWN
Last Update Posted:
2019-12-23
First Post:
2019-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Isoprinosine in HIV Patients With Viral Load > 50 y < 200 Copies/mL
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': 'D007542', 'term': 'Inosine Pranobex'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007288', 'term': 'Inosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-19', 'studyFirstSubmitDate': '2019-02-07', 'studyFirstSubmitQcDate': '2019-03-18', 'lastUpdatePostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Viral load', 'timeFrame': 'Change from Baseline viral load at 3 months', 'description': 'Number of viral copies/mL'}], 'secondaryOutcomes': [{'measure': 'CD4+ count', 'timeFrame': 'Change from Baseline CD4+ count at 3 months', 'description': 'Number of CD4+ cells'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Virological failure is a complication of treatment in patients with HIV, and it can be as high as 42% to first line treatment or around 18% in second line treatment. The reasons behind this phenomenon are several, including adherence to treatment (self-patient) or those related to the drugs (kinetics, interactions) and the virus itself (resistance patterns). People living with HIV needs treatment for all their lives, another factor to facilitate virus resistance and poor adherence to treatment. For that reason, it is necessary to look for additional therapeutic options to minimize this problem, and the use of immunomodulatory drugs is an interesting topic now. Among those drugs, isoprinosine hs been reported not only improve the immune response, it also has the capability to inhibit the replication of RNA virus. Then, we propose an open label clinical trial to evaluate the effect of isoprinosine in HIV patients with a virological load between 50 and 200 copies/ml.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years old.\n* Patients with a viral load (RNA of VIH) between \\> 50 and \\< 200 copies/mL after 24 weeks of antiviral therapy or after scheme change.\n* Informed consent signature\n\nExclusion Criteria:\n\n* Younger than 18 years old.\n* No virologic failure or RNA of VIH \\> 200 copies/mL.\n* Presence of a serious opportunistic infection.\n* Renal failure (including litiasis) or presence of gout.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT03883334', 'briefTitle': 'Isoprinosine in HIV Patients With Viral Load > 50 y < 200 Copies/mL', 'organization': {'class': 'OTHER', 'fullName': 'Universidad San Francisco de Quito'}, 'officialTitle': 'Efecto de la Isoprinosina en Pacientes Con infección Por VIH y Carga Viral Entre > 50 y < 200 Copias/mL de la Unidad de atención de PVV Del Hospital Enrique Garcés en Quito, Ecuador Durante el año 2019.', 'orgStudyIdInfo': {'id': 'HUBI - 12522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immunomodulator group', 'description': 'Metisoprinol 1 gr every 8 h per ten days during three months plus the combine antiretroviral therapy.', 'interventionNames': ['Drug: Metisoprinol']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'combine antiretroviral therapy only'}], 'interventions': [{'name': 'Metisoprinol', 'type': 'DRUG', 'otherNames': ['Isoprinosine'], 'description': 'Immunodulator', 'armGroupLabels': ['Immunomodulator group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '170901', 'city': 'Quito', 'country': 'Ecuador', 'facility': 'Hospital Enrique Garces', 'geoPoint': {'lat': -0.22985, 'lon': -78.52495}}], 'overallOfficials': [{'name': 'Enrique Teran, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad San Francisco de Quito'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad San Francisco de Quito', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Enrique Teran', 'investigatorAffiliation': 'Universidad San Francisco de Quito'}}}}