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Common TitleACTG 229 Non-Industry
Official Title Double-Blind, Randomized, Phase II Study of Saquinavir (Ro 31-8959) Plus Zidovudine (AZT) Versus AZT Plus Zalcitabine (Dideoxycytidine; ddC) Versus Saquinavir (Ro 31-8959) Plus AZT Plus ddC
Phase Phase II
ClinicalTrials.gov NCT00001040
Treatments
Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedDual TherapyResistance/Virological FailurePharmacologyGeneral Pharmacology
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Collier AC, Coombs RW, Schoenfeld DA, et al. Treatment of human immunodeficiency virus infection with saquinavir, zidovudine, and zalcitabine. AIDS Clinical Trials Group. N Engl J Med. 1996;334:1011-7.
- Schapiro JM, Lawrence J, Speck R, et al. Resistance mutations to zidovudine and saquinavir in patients receiving zidovudine plus saquinavir or zidovudine and zalcitabine plus saquinavir in AIDS clinical trials group 229. J Infect Dis. 1999;179:249-53.
- Vanhove GF, Gries JM, Verotta D, et al. Exposure-response relationships for saquinavir, zidovudine, and zalcitabine in combination therapy. Antimicrob Agents Chemother. 1997;41:2433-8.
Common TitleACTG 333 Non-Industry
Official Title The Antiviral Effect of Switching From Hard Capsule Saquinavir (SQVhc) to the Soft Gelatin Capsule of Saquinavir (SQVsc) Versus Switching to Indinavir (IDV) After 1 Year of Saquinavir Use
Phase Phase II
ClinicalTrials.gov NCT00000848
Treatments
Indinavir
, Indinavir
Tradename:CrixivanOther Names:IDVClass:Protease Inhibitors (PI)Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-ExperiencedSwitch/Simplification
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Para MF, Glidden DV, Coombs RW, et al. Baseline human immunodeficiency virus type 1 phenotype, genotype, and RNA response after switching from long-term hard-capsule saquinavir to indinavir or soft-gel-capsule saquinavir in AIDS clinical trials group protocol 333. J Infect Dis. 2000;182:733-43.
- Sevin AD, DeGruttola V, Nijhuis M, et al. Methods for investigation of the relationship between drug-susceptibility phenotype and human immunodeficiency virus type 1 genotype with applications to AIDS clinical trials group 333. J Infect Dis. 2000;182:59-67.
Common TitleACTG 359 Non-Industry
Official Title Activity of the Soft Gelatin Capsule of Saquinavir (SQVsgc) in Combination With Ritonavir or Nelfinavir and Combinations of Delavirdine and/or Adefovir Dipivoxil in HIV-Infected Subjects With Prior Indinavir Use and Viral Loads From 2,000 to 200,000 Copies HIV RNA/ml
ClinicalTrials.gov NCT00000892
Treatments
Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailureTreatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Fletcher CV, Jiang H, Brundage RC, et al. Sex-based differences in saquinavir pharmacology and virologic response in AIDS Clinical Trials Group Study 359. J Infect Dis. 2004;189:1176-84.
- Fletcher CV, Testa MA, Brundage RC, et al. Four measures of antiretroviral medication adherence and virologic response in AIDS clinical trials group study 359. J Acquir Immune Defic Syndr. 2005;40:301-6.
- Gulick RM, Hu XJ, Fiscus SA, et al. Durability of response to treatment among antiretroviral-experienced subjects: 48-week results from AIDS Clinical Trials Group Protocol 359. J Infect Dis. 2002;186:626-33.
- Gulick RM, Hu XJ, Fiscus SA, et al. Randomized study of saquinavir with ritonavir or nelfinavir together with delavirdine, adefovir, or both in human immunodeficiency virus-infected adults with virologic failure on indinavir: AIDS Clinical Trials Group Study 359. J Infect Dis. 2000;182:1375-84.
- Swanstrom R, Bosch RJ, Katzenstein D, et al. Weighted phenotypic susceptibility scores are predictive of the HIV-1 RNA response in protease inhibitor-experienced HIV-1-infected subjects. J Infect Dis. 2004;190:886-93.
Common TitleAI424-009 Industry
Official Title Safety and Antiviral Efficacy of a Novel HIV-1 Protease Inhibitor, Atazanavir (BMS-232632), in Combination Regimen(s) as Compared to a Reference Combination Regimen(s) in Antiretroviral-Experienced HIV-Infected Subjects
Phase Phase II
ClinicalTrials.gov NCT00004584
Treatments
Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailurePharmacologyTreatment-ExperiencedAdverse Effects
Funding
IndustryBristol-Myers Squibb
References
- Haas DW, Zala C, Schrader S, et al. Therapy with atazanavir plus saquinavir in patients failing highly active antiretroviral therapy: a randomized comparative pilot trial. AIDS. 2003;17:1339-49.
Common TitleBASIC Industry
Official Title A Randomised, Controlled, Open-Label, 48-Week, Study To Asses Differences in Changes In Plasma Lipid Profile Between Patients On Saquinavir/Ritonavir Or Atazanavir/Ritonavir In Combination With Tenofovir Disoproxil Fumarate And Emtricitabine As A First-line Regimen
Phase Phase IV
ClinicalTrials.gov NCT00389402
Treatments
Atazanavir
, Atazanavir
Tradename:ReyatazOther Names:ATVClass:Protease Inhibitors (PI)Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryHoffmann-La Roche
References
- Vrouenraets SM, Wit FW, Fernandez Garcia E, et al. Randomized comparison of metabolic and renal effects of saquinavir/r or atazanavir/r plus tenofovir/emtricitabine in treatment-naïve HIV-1-infected patients. HIV Med. 2011;12:620-31.
Official Title A 48-week, Randomized, Open-label, 2-arm Study to Compare the Efficacy of Saquinavir/Ritonavir Twice Daily (BID) Plus Emtricitabine/Tenofovir Once Daily (QD) Versus Lopinavir/Ritonavir BID Plus Emtricitabine/Tenofovir QD in Treatment-naïve Human Immunodeficiency Virus Type 1 (HIV-1) Infected Patients (GEMINI Study)
Phase Phase III
ClinicalTrials.gov NCT00105079
Treatments
Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Saquinavir
, Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Ritonavir
Ritonavir
Tradename:NorvirOther Names:RTVClass:Pharmacokinetic EnhancersCategories PharmacologyTreatment-NaiveAdverse Effects
Funding
IndustryHoffmann-La Roche
References
- Walmsley S, Avihingsanon A, Slim J, et al. Gemini: a noninferiority study of saquinavir/ritonavir versus lopinavir/ritonavir as initial HIV-1 therapy in adults. J Acquir Immune Defic Syndr. 2009;50:367-74.
Official Title Lopinavir/r Plus Saquinavir Salvage Therapy in HIV-infected Children With NRTI and/or NNRTI Failure: PK and Two-year Treatment Follow up
Phase Phase IV
ClinicalTrials.gov NCT00476359
Treatments
Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailurePharmacologyPediatricsTreatment-ExperiencedGeneral PharmacologyAdverse Effects
Funding
Non-IndustryHIV Netherlands Australia Thailand Research Collaboration
References
- Ananworanich J, Kosalaraksa P, Hill A, et al. Pharmacokinetics and 24-week efficacy/safety of dual boosted saquinavir/lopinavir/ritonavir in nucleoside-pretreated children. Pediatr Infect Dis J. 2005;24:874-9.
- Bunupuradah T, van der Lugt J, Kosalaraksa P, et al. Safety and efficacy of a double-boosted protease inhibitor combination, saquinavir and lopinavir/ritonavir, in pretreated children at 96 weeks. Antivir Ther. 2009;14:241-8.
- Kosalaraksa P, Bunupuradah T, Engchanil C, et al. Double boosted protease inhibitors, saquinavir, and lopinavir/ritonavir, in nucleoside pretreated children at 48 weeks. Pediatr Infect Dis J. 2008;27:623-8.
Common TitleMaxCmin2 Industry
Official Title A randomized trial to evaluate lopinavir/ritonavir versus saquinavir/ritonavir in HIV-1-infected patients: the MaxCmin2 trial
Phase Phase IV
Treatments
Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories Treatment-NaiveTreatment-Experienced
Funding
IndustryRoche Pharmaceutical Ltd.
References
- Dragsted UB, Gerstoft J, Youle M, et al. A randomized trial to evaluate lopinavir/ritonavir versus saquinavir/ritonavir in HIV-1-infected patients: the MaxCmin2 trial. Antivir Ther. 2005;10:735-43.
Common TitleNV 14256 Industry
Official Title A Randomized, Double-Blind, Multicenter, Parallel Study of Ro 31-8959 (Saquinavir; HIV Proteinase Inhibitor) Alone, HIVID (Dideoxycytidine; Zalcitabine, ddC) Alone, and Both in Combination, as Treatment for Advanced HIV Infection (CD4 50-300 Cells/mm3) in Patients Discontinuing or Unable to Take Retrovir (Zidovudine; AZT) Therapy
Phase Phase II
ClinicalTrials.gov NCT00002333
Treatments
Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories Treatment-ExperiencedDual TherapyMonotherapy
Funding
IndustryHoffmann-La Roche
References
- Revicki DA, Swartz C, Wu AW, Haubrich R, Collier AC. Quality of life outcomes of saquinavir, zalcitabine and combination saquinavir plus zalcitabine therapy for adults with advanced HIV infection with CD4 counts between 50 and 300 cells/mm3. Antivir Ther. 1999;4:35-44.
Common TitlePACTG 386 Non-Industry
Official Title A Phase I Trial of the Safety and Pharmacokinetics of Fortovase (Saquinavir-SGC) Co-Administered With Low Dose (Ritonavir) RTV, ZDV and 3TC in HIV Seropositive Pregnant Women During Gestation and Postpartum, and in Their Infant's Post-Maternal Dosing
Phase Phase I
ClinicalTrials.gov NCT00000920
Treatments
Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories PharmacologyPregnancy/WomenTreatment-NaiveTreatment-ExperiencedDrug Interactions
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Acosta EP, Bardeguez A, Zorrilla CD, et al. Pharmacokinetics of saquinavir plus low-dose ritonavir in human immunodeficiency virus-infected pregnant women. Antimicrob Agents Chemother. 2004;48:430-6.
Official Title The purpose of this study is to determine the effect of increased doses of lopinavir/ritonavir (LPV/r) and saquinavir (SQV) in HIV infected children who are failing their current antiretroviral regimen
Phase Phase II
ClinicalTrials.gov NCT00084058.
Treatments
Lopinavir-Ritonavir
, Lopinavir-Ritonavir
Tradename:KaletraOther Names:LPV-RTVClass:Protease Inhibitors (PI)Saquinavir
Saquinavir
Tradename:InviraseOther Names:SQVClass:Protease Inhibitors (PI)Categories Resistance/Virological FailurePediatricsTreatment-Experienced
Funding
Non-IndustryNational Institute of Allergy and Infectious Diseases (NIAID)
References
- Robbins BL, Capparelli EV, Chadwick EG, et al. Pharmacokinetics of high-dose lopinavir-ritonavir with and without saquinavir or nonnucleoside reverse transcriptase inhibitors in human immunodeficiency virus-infected pediatric and adolescent patients previously treated with protease inhibitors. Antimicrob Agents Chemother. 2008;52:3276-83.
Clinical Trial Image Decks
GEMINI - January 8, 2020
HIV-NAT 017 - July 5, 2017
PACTG 1038 - July 5, 2017