67 completed, 2 withdrawn, 1 terminated, 1 unknown. 33 Phase 2, 16 Phase 3, 14 Phase 1, 9 Phase 4, 4 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 33 | Completed 30, Withdrawn 2, Terminated 1 |
| Phase 3 | 16 | Completed 15, Withdrawn 1 |
| Phase 1 | 14 | Completed 14 |
| Phase 4 | 9 | Completed 9 |
| Not applicable | 4 | Completed 4 |
| Early Phase 1 | 1 | Unknown 1 |
Follow Saquinavir: new trials by email Literature Review of Saquinavir trials Research Report on Saquinavir
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Testing of HIV Protease Inhibitors to Suppress Inflammation and Improve Cardio Pulmonary Hemodynamics in Subjects With Pulmonary Arterial Hypertension saquinavir and ritonavir - Pulmonary Arterial Hypertension | Early Phase 1 | Unknown | The Third Xiangya Hospital of Central South University | 20 | 2013-12-01 | 2014-09-08 |
| A Study of Ritonavir-Boosted Invirase (Saquinavir) in Treatment-Naïve HIV-1 Infected Patients Nucleoside Reverse Transcriptase Inhibitor (NRTIs), ritonavir, saquinavir [Invirase] - HIV Infections | Phase 1 | Completed | Hoffmann-La Roche | 23 | 2012-01-01 | 2016-11-02 |
| Pharmacokinetics, Safety And Toleration Of Maraviroc Administered To Subjects With Various Degrees Of Renal Impaired And Normal Renal Function Maraviroc, Ritonavir, Saquinavir - Human Immunodeficiency Virus (HIV) Infection | Phase 4 | Completed | ViiV Healthcare | 30 | 2008-07-01 | 2010-11-19 |
| A Study of Invirase (Saquinavir)/Ritonavir in HIV-Infected Infants and Children. ritonavir, saquinavir [Invirase] - HIV Infections | Phase 2 | Completed | Hoffmann-La Roche | 18 | 2008-06-01 | 2016-03-07 |
| Pharmacokinetics of Low Dose Ritonavir ritonavir and saquinavir - HIV Infections | Phase 1 / Phase 2 | Completed | The HIV Netherlands Australia Thailand Research Collaboration | 20 | 2008-01-01 | 2012-04-05 |
| Clinical Trial of CNS-targeted HAART (CIT2) FDA Approved Antiretroviral Therapy (see list below) - HIV Infections | Phase 2 / Phase 3 | Completed | University of California, San Diego | 59 | 2007-03-01 | 2014-04-23 |
| Lopinavir Capsules to Kaletra or Invirase Tablets Saquinavir (Invirase®), Lopinavir/ritonavir (Kaletra®) - HIV Infections | Phase 4 | Completed | Royal Free Hampstead NHS Trust | 53 | 2006-09-01 | 2011-07-18 |
| A Study of Saquinavir/Ritonavir in Liver-Impaired Patients With HIV Infection. Ritonavir, saquinavir [Invirase] - HIV Infections | Phase 1 | Completed | Hoffmann-La Roche | 16 | 2006-09-01 | 2018-03-29 |
| BASIC: Boosted Atazanavir or Saquinavir Induced Lipid Changes saquinavir/ritonavir, atazanavir/ritonavir - HIV Infections | Phase 4 | Completed | International Antiviral Therapy Evaluation Center | 120 | 2006-07-01 | 2010-06-11 |
| Saquinavir/Ritonavir in Single Therapy as Maintenance Treatment Saquinavir/Ritonavir : 2 capsules (500 mg) / 12 hours - HIV Infections | Phase 4 | Completed | Germans Trias i Pujol Hospital | 30 | 2006-06-01 | 2019-12-04 |
| Dual Boosted Protease Inhibitor Regimens Without Any Additional Antiretroviral Therapy in HIV-1 Infected Patients (ANRS127) Fosamprenavir, Saquinavir - HIV Infections | Phase 2 | Completed | French National Agency for Research on AIDS and Viral Hepatitis | 61 | 2005-12-01 | 2026-04-02 |
| The Pharmacokinetic Study of Saquinavir New Tablet Formulation in HIV-infected Pregnant Women. Saquinavir and Ritonavir - HIV Infections | Phase 1 / Phase 2 | Completed | Radboud University Medical Center | 40 | 2005-08-01 | 2020-10-19 |
| GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection saquinavir [Invirase], Lopinavir/ritonavir, Emtricitabine/tenofovir disoproxil fumarate - HIV Infections | Phase 3 | Completed | Hoffmann-La Roche | 337 | 2005-04-01 | 2011-11-02 |
| Study to Determine the Pharmacokinetic Behavior of Antiretroviral Drugs in Patients Infected by HIV Nevirapine, Efavirenz, Indinavir/ritonavir - HIV Infections | Phase 1 | Completed | Germans Trias i Pujol Hospital | 675 | 2005-01-01 | 2019-12-04 |
| Efficacy and Safety of SQV in Patients Who Have Chronic IDV Nephrotoxicity Saquinavir - IDV Associated Nephrotoxicity | Phase 2 | Completed | The HIV Netherlands Australia Thailand Research Collaboration | 30 | 2004-05-01 | 2016-02-22 |
| Directly Observed Therapy in High Risk Populations in Newark, NJ Invirase, Norvir - Directly Observed Therapy, HIV Infections | Phase 3 | Completed | Saint Michael's Medical Center | 30 | 2004-04-01 | 2006-02-28 |
| The Pharmacokinetics of Double Boosted Protease Inhibitors in Antiretroviral-naive HIV-1 Infected Patients Saquinavir, lopinavir, ritonavir - HIV Infections | Phase 2 | Completed | The HIV Netherlands Australia Thailand Research Collaboration | 48 | 2004-03-01 | 2012-04-05 |
| Effect of an Enfuvirtide-based Anti-HIV Drug Regimen on Latent HIV Reservoirs in Treatment Naive Adults Emtricitabine, Enfuvirtide, Ritonavir - HIV Infections | Not applicable | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 19 | 2003-10-01 | 2021-11-01 |
| A PK and Salvage Study for Children With HIV-infection Lopinavir/r plus saquinavir - HIV Infections | Phase 4 | Completed | The HIV Netherlands Australia Thailand Research Collaboration | 50 | 2003-10-01 | 2015-03-27 |
| A Prospective Cohort of Children With HIV Infection Zidovudine, Stavudine, Didanosine, Lamivudine, Nevirapine, Efavirenz, LPV/r, Saquinavir, Indinavir, Ritonavir, Nelfinavir - HIV Infections | Completed | The HIV Netherlands Australia Thailand Research Collaboration | 500 | 2003-03-01 | 2025-03-17 |
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HIV Infections (66) · Acquired Immunodeficiency Syndrome (11) · AIDS-Related Complex (7) · Lipodystrophy (2) · AIDS Dementia Complex (1) · AIDS-Associated Nephropathy (1) · AIDS-related Kaposi sarcoma (1) · Adolescent Behavior (1) · Cardiovascular Diseases (1) · Cognitive Dysfunction (1) · Directly Observed Therapy (1) · HIV-Associated Lipodystrophy Syndrome (1) · Hypersensitivity, Delayed (1) · Kidney Failure, Chronic (1) · Pregnancy Complications (1)
Hoffmann-La Roche (21) · National Institute of Allergy and Infectious Diseases (NIAID) (19) · The HIV Netherlands Australia Thailand Research Collaboration (6) · Abbott (3) · Boehringer Ingelheim (2) · Bristol-Myers Squibb (2) · Germans Trias i Pujol Hospital (2) · Glaxo Wellcome (2) · Eastern Cooperative Oncology Group (1) · French National Agency for Research on AIDS and Viral Hepatitis (1) · Gilead Sciences (1) · International Antiviral Therapy Evaluation Center (1) · Kirby Institute (1) · National Institutes of Health Clinical Center (CC) (1) · Parexel (1)
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PMID 11023461, PMID 12195349, PMID 15031785, PMID 15295692, PMID 16048950, PMID 16220084, PMID 16249704, PMID 17507321, PMID 17726714, PMID 18520443, PMID 18625762, PMID 18647794, PMID 19118378, PMID 19420019, PMID 19430099, PMID 19474478, PMID 20001856, PMID 21288774, PMID 21337357, PMID 22026962, PMID 23494984, PMID 24352352, PMID 24625136, PMID 26401255, PMID 27516476
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