Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT00324103
Status:
COMPLETED
Last Update Posted:
2006-05-10
First Post:
2006-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Structured Treatment Interruptions in Chronic HIV Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000088562', 'term': 'Persistent Infection'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-10', 'completionDateStruct': {'date': '2004-06'}, 'lastUpdateSubmitDate': '2006-05-08', 'studyFirstSubmitDate': '2006-05-08', 'studyFirstSubmitQcDate': '2006-05-08', 'lastUpdatePostDateStruct': {'date': '2006-05-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'proportion of patients with CD4+ cell count above 500/mm3 at the end of follow-up (2 years) in the two treatment arms.'}], 'secondaryOutcomes': [{'measure': 'occurrence of grade 3 or 4 adverse events (clinical and laboratory)'}, {'measure': 'proportion of patients with HIV-RNA < 400 copies/ml at the end of follow-up'}, {'measure': 'proportion of patients with CD4+ cell count > 350/mm3 at the end of follow-up'}, {'measure': 'rate of virological failure'}, {'measure': 'emergence of resistance'}, {'measure': 'HIV-related events.'}]}, 'conditionsModule': {'keywords': ['HIV', 'Chronic Infection', 'Clinical Trial', 'Structured Treatment Interruption'], 'conditions': ['HIV Infection']}, 'descriptionModule': {'briefSummary': "In the last years Structured Treatment Interruptions (STI) have been proposed to reduce HAART-related toxicity and to increase patients' compliance. ISS PART is a randomized comparison of repeated STIs versus continuous HAART in chronically HIV-infected subjects with persistent suppression of viral replication. The two arms of the study will be compared in terms of immunological response (proportion of patients with CD4\\>500/mmc) at 2 years.", 'detailedDescription': "Patients are randomized in a 1 to 1 ratio to continue their current antiretroviral regimen (Arm A) or to undergo structured treatment interruptions (STI) (Arm B) according to the following scheme: STIs of 1, 1, 2, 2 and 3 months each followed by a 3-month therapy period.\n\nDuring STIs, therapy is resumed in the presence of an HIV-RNA rebound \\> 50,000 copies/ml or of a CD4+ T cell decline \\> 25% of the baseline count (\\> 35% for patients with CD4+ \\> 500/mm3 at randomization). After the first cycle, subsequent STIs are performed only if an HIV-RNA level \\< 400 copies/ml is reached after 2 months of therapy resumption.\n\nAt the time of treatment interruptions patients in arm B who are on treatment with non-nucleoside reverse transcriptase inhibitors suspend these drugs first and continue the treatment with the other drugs of the combination for 3 days if nevirapine-treated and for 6 days in case of previous efavirenz-based regimen.\n\nPatients are seen at the clinical site every three months for arm A and monthly for arm B. On these occasions, blood samples are obtained for biochemical and viro-immunological assessments.\n\nThe toxicity grading scale of the AIDS Clinical Trial Group (ACTG) is used for the reporting of clinical and laboratory adverse events.\n\nIn arm B, plasma genotype is obtained in samples taken after 15 or 30 days of drug suspension.\n\nPatients will discontinue the study in case of : early therapy resumption for 2 consecutive times (only arm B patients); acute retroviral syndrome (only for arm B patients); AIDS-defining event; severe adverse event; pregnancy; non-compliance; patient' s request; physician's decision."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* first-line antiretroviral therapy (3 or 4 drugs) for 6 to 18 months (one previous therapy change for toxicity or non-compliance is allowed)\n* HIV-RNA level below 400 copies/ml for at least 6 months;\n* CD4+ count \\> 350 /mm3;\n* pre-HAART CD4+ \\> 100/mm3\n* no previous AIDS diagnosis.\n\nExclusion Criteria:\n\n* Previous antiretroviral therapy with 1 or 2 drugs (except ARV prophylaxis in pregnancy)\n* Pregnancy or breastfeeding\n* Previous diagnosis of AIDS\n* Grade 3 or 4 adverse event in the 15 days before enrolment\n* Neoplasia\n* Previous therapy with IL-2, interferon (in the last 2 years) or experimental therapies'}, 'identificationModule': {'nctId': 'NCT00324103', 'briefTitle': 'Structured Treatment Interruptions in Chronic HIV Infection', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Superiore di Sanità'}, 'officialTitle': 'Antiretroviral Treatment With Structured Treatment Interruptions (STI) Versus Continuous Antiretroviral Treatment in HIV+ Patients With Persistent Suppression of Viral Replication', 'orgStudyIdInfo': {'id': 'ISS PART'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Structured Treatment Interruptions', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00161', 'city': 'Rome', 'country': 'Italy', 'facility': 'Istituto Superiore di Sanità', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Stefano Vella, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Istituto Superiore di Sanità'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Superiore di Sanità', 'class': 'OTHER'}}}}