Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT00379405
Status:
COMPLETED
Last Update Posted:
2019-12-04
First Post:
2006-09-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment
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': 'D019258', 'term': 'Saquinavir'}, {'id': 'D019438', 'term': 'Ritonavir'}], 'ancestors': [{'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011804', 'term': 'Quinolines'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-03', 'studyFirstSubmitDate': '2006-09-20', 'studyFirstSubmitQcDate': '2006-09-20', 'lastUpdatePostDateStruct': {'date': '2019-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Virological response: Viral Load', 'timeFrame': 'weeks 24 and 48'}], 'secondaryOutcomes': [{'measure': 'CD4 and CD8 lymphocyte count.', 'timeFrame': 'weeks 24 and 48'}, {'measure': 'Physical Exploration: including weight, height, index waist/hip (the abdominal perimeter is measured between the last floating rib and the iliac crest), assessment of changes in body fat distribution,...', 'timeFrame': 'weeks 24 and 48'}, {'measure': 'Karnofsky Index.', 'timeFrame': 'weeks 24 and 48'}, {'measure': 'Adverse events.', 'timeFrame': 'during the 48 weeks of follow-up'}, {'measure': 'Trough plasma concentrations of Saquinavir.', 'timeFrame': 'during the 48 weeks of follow-up'}, {'measure': 'Lipid study in plasma (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides)', 'timeFrame': 'during the 48 weeks of follow-up'}, {'measure': 'Serology for Hepatitis B and C virus.', 'timeFrame': 'at baseline visit'}, {'measure': 'Assessment of treatment adherence.', 'timeFrame': 'at baseline and weeks 4, 12, 24, 36 and 48'}, {'measure': 'Assessment of quality of life (by means of the MOS-HIV questionnaire).', 'timeFrame': 'at baseline and weeks 4, 12, 24, 36 and 48'}, {'measure': 'Genotype if virological failure.', 'timeFrame': 'at any time of study if it is necessary'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Saquinavir/ritonavir', 'Single therapy', 'Virological efficacy', 'Safety', 'HIV-1'], 'conditions': ['HIV Infections']}, 'descriptionModule': {'briefSummary': 'Study the efficacy of Saquinavir/Ritonavir when given in single therapy as maintenance therapy, compared to standard HAART therapies.', 'detailedDescription': 'Different therapeutic strategies have been investigated to improve adherence to treatment and reduce toxicity. Both the reduction in the number of doses and the number of daily tablets have led to an improvement in therapeutic compliance. Similarly, the administration of new treatment regimens with a reduced number of tablets a day and without NTRI may be clinically useful in improving compliance with HAART and limiting NTRI-associated toxicity. These would comprise combinations of a PI, boosted with ritonavir, plus a non-Nucleoside and single therapy with PIs boosted with ritonavir.\n\nIn this regard, the results obtained with lopinavir/ritonavir and with atazanavir/ritonavir are very promising and open up a possible channel of research with other PIs boosted with low doses of ritonavir.\n\nThere are other PIs whose antiretroviral efficacy has also been demonstrated, such as saquinavir, but whose economic cost is much lower. Furthermore, saquinavir has a low toxicity profile, and the availability of saquinavir 500 mg facilitates comfortable administration, since it makes it possible to reduce the number of daily tablets to more than half.\n\nMoreover, it is important to take into account that the incidence of mutations that confer resistance to saquinavir on patients that fail on combinations including this PI is very low, which makes it possible to reuse the drug in future treatment regimens or salvage patients with other PI All these characteristics (high intrinsic potency, low number of tablets, low toxicity, low potential of selection of resistant viral strains in combination with ritonavir, and low economic cost) make single therapy with the new formulation of saquinavir, boosted with low doses of ritonavir, a possible therapeutic option as maintenance strategy in HIV-infected patients with maintained suppression of the viral load.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients infected by HIV-1 (at least one documented positive Western-Blot).\n* Age \\> 18 years.\n* Patients on antiretroviral treatment (standard HAART therapy) for at least six months.\n* HIV-1 plasma viral load \\<50 copies/mL (documented in at least two determinations performed over the six months prior to the inclusion visit).\n* Patients without evidence of previous virological failure to IP\n* Absence of opportunistic infections and/or tumours in the three months prior to inclusion.\n* Subject able to follow the treatment period, without any suspicion of poor adherence during previous antiretroviral treatments.\n* Signature of the informed consent.\n\nExclusion Criteria:\n\n* Suspicion of unsuitable antiretroviral treatment compliance.\n* Documented existence of any of the primary mutations in the protease gene or 3 or more of the following: L10F/I/R/V, K20M/R, M36I/V, I54L/T/V, L63P, A71T/V , V82A/F/T/S, I84A/V OR L90M.\n* Known allergic hypersensitivity to any of the investigational drugs or any similar drug.\n* Hepatic tests (AST, ALT, GGT) \\> or equal to 5 times the upper limit of normality during the three months prior to the screening visit\n* Presence of renal impairment (creatinine \\> or equal to 1.5 times the upper limit of normality).\n* Pregnancy or breastfeeding. Refusal to use reliable contraceptive methods during the study period.\n* Participation in another clinical trial wich entail the antiretroviral treatment modification.'}, 'identificationModule': {'nctId': 'NCT00379405', 'briefTitle': 'Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Germans Trias i Pujol Hospital'}, 'officialTitle': 'Open-label, Comparative and Randomised Pilot Study to Evaluate the Efficacy and Safety of Saquinavir/Ritonavir in Single Therapy vs Standard HAART Therapy as Maintenance Therapy.', 'orgStudyIdInfo': {'id': 'SQV/RTV-MONOTERAPIA'}, 'secondaryIdInfos': [{'id': '2006-001136-47'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Saquinavir (Invirase): 2 capsules (500 mg) / 12 hours', 'interventionNames': ['Drug: Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'IP o NNUCS + 2 NUCS as a HAART therapy .'}], 'interventions': [{'name': 'Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours', 'type': 'DRUG', 'otherNames': ['Invirase'], 'description': 'Saquinavir/Ritonavir: 2 capsules (500 mg) / 12 hours', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08916', 'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Germans Trias i Pujol University Hospital', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Sant Pau.', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Clotet Bonaventura, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari Germans Trias i Pujol. Badalona (Barcelona)'}, {'name': 'Negredo Eugenia, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)'}, {'name': 'Echeverria Patricia, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)'}, {'name': 'Molto Jose, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitari Germans Trias i Pujol. Badalona. (Barcelona)'}, {'name': 'Pere Domingo, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Sant Pau'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Germans Trias i Pujol Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}