Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-04-19 @ 2:37 AM
Study NCT ID:
NCT02239835
Status:
TERMINATED
Last Update Posted:
2014-09-15
First Post:
2014-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tipranavir and Ritonavir vs. Saquinavir and Ritonavir Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients
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': 'C107201', 'term': 'tipranavir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D019258', 'term': 'Saquinavir'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011804', 'term': 'Quinolines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '1999-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'lastUpdateSubmitDate': '2014-09-11', 'studyFirstSubmitDate': '2014-09-11', 'studyFirstSubmitQcDate': '2014-09-11', 'lastUpdatePostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in plasma HIV-1 RNA concentrations', 'timeFrame': 'Week 16, 24 and 48'}, {'measure': 'Occurrence of HIV-1 RNA levels below the limit of quantitation (BLQ)', 'timeFrame': 'up to 96 weeks', 'description': 'using the Roche Amplicor HIV Monitor™ Method \\[limit of detection (LD) 400 copies/mL\\] and the Roche Amplicor UltraSensitive Method™ (LD 50 copies/mL)'}, {'measure': 'Number of patients with treatment-emergent and drug-related adverse events (AEs)', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Number of patients with serious adverse events (SAEs)', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Number of patients with grade 3 and 4 laboratory abnormalities', 'timeFrame': 'up to 96 weeks'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in cluster of differentiation (CD) 4+ cell count', 'timeFrame': 'Week 16, 24 and 48'}, {'measure': 'Time to virologic failure', 'timeFrame': 'after week 16', 'description': 'defined as plasma HIV-1 RNA values \\>400 copies/mL at two consecutive time points 2 to 4 weeks apart'}, {'measure': 'Occurrence of new or recurring AIDS-defining illnesses', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Occurrence of HIV-1 related illness', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Occurrence of death', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Time to new or recurring AIDS-defining illnesses', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Time to HIV-1 related illness', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Time to death', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Change from baseline in blood glucose', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Change from baseline in cholesterol', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Change from baseline in high density lipoprotein (HDL)', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Change from baseline in triglycerides', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Time to virologic response', 'timeFrame': 'up to 96 weeks'}, {'measure': 'Trough plasma tipranavir concentrations', 'timeFrame': 'up to week 24'}, {'measure': 'Sequence-based HIV-1 analysis (genotyping) and drug susceptibility assays (phenotyping)', 'timeFrame': 'Baseline and week 24'}]}, 'conditionsModule': {'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Objectives of the study were to evaluate the efficacy and safety of two different doses of tipranavir (TPV) in combination with ritonavir (TPV/r) compared with a standard dual PI combination of saquinavir (SQV) and ritonavir (RTV) and to evaluate the dose response of two different doses of TPV in combination with RTV for efficacy and safety.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical failure while on the current PI-containing regimen of indinavir, nelfinavir, or amprenavir\n* In the investigator's opinion, adherence to the present PI-containing regimen\n* Exposure of \\>=6 months to the current PI therapy\n* Stable PI-containing regimen, i.e., receiving the current two reverse transcriptase inhibitors (RTIs) for at least 2 months prior to study entry\n* HIV-1 RNA \\>=1000 copies/mL (assayed using the Amplicor polymerase chain reaction (PCR) method at the initial screening visit)\n* No limit in CD4+ cell count at the initial screening\n* At least two new nucleoside reverse transcriptase inhibitor (NRTI) options available\n* Age \\>=18 years\n* Acceptable screening laboratory test values that indicated adequate baseline organ function at the time of screening. Acceptable laboratory test values consisted of the following: severity \\<=Grade 1 (ACTG Grading Scale). Stable Grade 2 abnormalities were permitted if the values had been demonstrated and documented for at least \\>=2 months. All laboratory values \\>Grade 2 were subject to approval by the P\\&U Clinical Program Leader or designated personnel and subsequently by the BI designated personnel\n* Acceptable medical history, physical examination, ECG, and chest radiograph prior to entry into the treatment phase of the study\n* Use of a barrier contraceptive method of birth control for at least 30 days prior to study drug administration, during the study, and 30 days after study completion\n* Ability to swallow numerous tablets and capsules without difficulty\n* Ability to understand and provide informed consent. Minors had to have approval of a parent or legal guardian\n\nExclusion Criteria:\n\n* Treatment with more than one PI-containing regimen\n* Clinically significant active or acute (onset within the month previous to study entry) medical problems, including the following: opportunistic infections, e.g., active cryptococcosis, Pneumocystis carinii pneumonia, herpes zoster, histoplasmosis, or cytomegalovirus; nonopportunistic diseases, including but not limited to the following: progressive multifocal leukoencephalopathy, lymphoma, or malignancy requiring systemic therapy\n* Prior exposure (\\>7 days) to tipranavir, saquinavir, or ritonavir\n* History of clinically significant nervous system or muscle diseases, seizure disorder, or psychiatric disorder that might impair adherence to the protocol\n* Taking of any known P450 3A enzyme-inducing drugs within 30 days of study entry and including the following: rifabutin, rifampin, carbamazepine, dexamethasone, phenobarbital, phenytoin, sulfadimidine, sulfinpyrazone, or troleandomycin\n* Hypersensitivity to tipranavir, saquinavir, or ritonavir\n* Use of interferons, interleukins, HIV vaccines, or any active immunizations within 30 days of study entry\n* Taking of any investigational medication with the exception of adefovir dipivoxil (Preveon™) within 30 days of study entry\n* Pregnancy or lactation (serum β-human chorionic gonadotrophin test had to have been negative within 14 days of study entry)\n* Evidence of substance abuse, which in the investigator's opinion could affect adherence to the protocol\n* In the investigator's judgment, inability to comply with the protocol requirements for reasons other than those specified"}, 'identificationModule': {'nctId': 'NCT02239835', 'briefTitle': 'Tipranavir and Ritonavir vs. Saquinavir and Ritonavir Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Tipranavir: An Open-label, Randomized Study Comparing Combination Therapy (Tipranavir and Ritonavir vs. Saquinavir and Ritonavir) Used With Two Nucleoside Reverse Transcriptase Inhibitors in Single Protease Inhibitor-experienced HIV-1 Patients', 'orgStudyIdInfo': {'id': '1182.4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TPV low dose + RTV low dose', 'interventionNames': ['Drug: Tipranavir (TPV) low dose', 'Drug: Ritonavir low dose']}, {'type': 'EXPERIMENTAL', 'label': 'TPV high dose + RTV low dose', 'interventionNames': ['Drug: Tipranavir (TPV) high dose', 'Drug: Ritonavir low dose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SQV + RTV high dose', 'interventionNames': ['Drug: Ritonavir high dose', 'Drug: Saquinavir']}], 'interventions': [{'name': 'Tipranavir (TPV) low dose', 'type': 'DRUG', 'armGroupLabels': ['TPV low dose + RTV low dose']}, {'name': 'Tipranavir (TPV) high dose', 'type': 'DRUG', 'armGroupLabels': ['TPV high dose + RTV low dose']}, {'name': 'Ritonavir low dose', 'type': 'DRUG', 'armGroupLabels': ['TPV high dose + RTV low dose', 'TPV low dose + RTV low dose']}, {'name': 'Ritonavir high dose', 'type': 'DRUG', 'armGroupLabels': ['SQV + RTV high dose']}, {'name': 'Saquinavir', 'type': 'DRUG', 'armGroupLabels': ['SQV + RTV high dose']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}