31 completed, 5 terminated, 2 unknown, 1 withdrawn. 13 Phase 4, 12 Phase 2, 7 Phase 3, 5 Phase 1, 3 Not applicable.
Follow Enfuvirtide: new trials by email Literature Review of Enfuvirtide trials Research Report on Enfuvirtide
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 |
|---|---|---|---|---|---|---|
| Optimized Antiretroviral Therapy During Allogeneic Hematopoietic Stem Cell Transplantation in HIV-1 Individuals Enfuvirtide - HIV | Early Phase 1 | Completed | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 11 | 2013-06-01 | 2021-11-23 |
| Fasting on Newly Diagnosed Breast Cancer Doxorubicin, cyclophosphamide, paclitaxel - HER2-positive Breast Cancer | Phase 1 / Phase 2 | Terminated | Western Regional Medical Center | 8 | 2013-01-01 | 2018-04-24 |
| INNOVE Study: A Study of 3 Months Induction With Fuzeon (Enfuvirtide) + Optimized Background (OB) Versus OB Alone in HIV-1 Infected Patients With Virological Failure. enfuvirtide [Fuzeon], Optimized background ARV therapy - HIV Infections | Phase 2 | Completed | Hoffmann-La Roche | 29 | 2008-01-01 | 2015-01-27 |
| Optimizing Treatment for Treatment-Experienced, HIV-Infected People Enfuvirtide, Raltegravir, Darunavir - HIV Infections | Phase 3 | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | 517 | 2008-01-01 | 2021-11-04 |
| A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients enfuvirtide [Fuzeon], Optimized background ARV, Integrase inhibitor - HIV Infections | Phase 4 | Terminated | Hoffmann-La Roche | 29 | 2007-06-01 | 2011-07-22 |
| Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses raltegravir potassium, darunavir/ritonavir, etravirine - HIV Infections | Phase 2 | Completed | French National Agency for Research on AIDS and Viral Hepatitis | 103 | 2007-05-01 | 2010-09-17 |
| ESP Study: A Study to Assess the Effect of Adding Fuzeon (Enfuvirtide) to an Antiretroviral Regimen in Fuzeon-Naive Patients With Sustained HIV Viral Suppression. enfuvirtide [Fuzeon], Antiretroviral therapy - HIV Infections | Phase 4 | Withdrawn | Hoffmann-La Roche | 2007-04-01 | 2016-08-24 | |
| 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 |
| SPRING: Safety, Efficacy, Pharmacokinetics of tipRanavir/r IN Race/Gender HIV+ Patients Randomized to TDM or SoC tipranavir, ritonavir, Optimized Background Regimen (OBR) - HIV Infections | Phase 3 | Terminated | Boehringer Ingelheim | 33 | 2007-02-01 | 2014-06-27 |
| Study of Valproic Acid to Treat HIV Infected Adults Enfuvirtide, Valproic acid - HIV Infections | Phase 1 | Terminated | University of North Carolina, Chapel Hill | 14 | 2006-06-01 | 2012-05-14 |
| BOSS Study: A Study of Fuzeon Using the Needle-Free Biojector 2000 in Patients With HIV-1 Infection enfuvirtide [Fuzeon] - HIV Infections | Phase 4 | Completed | Hoffmann-La Roche | 326 | 2006-06-01 | 2015-11-03 |
| Intensification With Enfuvirtide in Naive HIV-infected Patients (ANRS130) enfuvirtide, emtricitabine/tenofovir, lopinavir or efavirenz - HIV Infections, AIDS | Phase 3 | Completed | French National Agency for Research on AIDS and Viral Hepatitis | 195 | 2006-04-01 | 2026-04-07 |
| BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1. Background ARVs, PI, enfuvirtide [Fuzeon] - HIV Infections | Phase 4 | Completed | Hoffmann-La Roche | 142 | 2006-03-01 | 2016-08-16 |
| Fuzeon Viral Decay Pilot Study enfuvirtide - HIV-1 | Not applicable | Completed | Canadian Immunodeficiency Research Collaborative | 18 | 2006-02-01 | 2012-06-05 |
| A Study to Evaluate the Safety and Efficacy of Adding Enfuvirtide to Oral Highly Active Antiretroviral Therapy (HAART) in Human Immunodeficiency Virus (HIV) Patients With Prior Treatment Experience Enfuvirtide, Highly active antiretroviral treatment (HAART) - HIV Infections | Phase 4 | Completed | Hoffmann-La Roche | 47 | 2005-11-01 | 2015-08-13 |
| Metabolic Effects of Enfuvirtide in Healthy Volunteers Enfuvirtide, Placebo - HIV Infections | Phase 4 | Completed | Hospital Clinic of Barcelona | 15 | 2005-09-01 | 2008-04-14 |
| WAND Study - A Study to Evaluate Fuzeon (Enfuvirtide) Administered by a Needle-Free Injection Device in Patients With HIV. enfuvirtide [Fuzeon] - HIV Infections | Phase 4 | Completed | Hoffmann-La Roche | 58 | 2005-08-01 | 2015-11-03 |
| A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study Etravirine (ETR), Nucleotide reverse transcriptase inhibitors (NRTIs), Protease inhibitors (PIs) - Human Immunodeficiency Virus Type 1 | Phase 2 | Completed | Tibotec Pharmaceuticals, Ireland | 211 | 2005-06-01 | 2013-06-20 |
| A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection enfuvirtide - HIV Infections | Phase 4 | Completed | Hoffmann-La Roche | 6 | 2005-04-01 | 2016-11-02 |
| Early Intensification of Antiretroviral Therapy Including Enfuvirtide in HIV-1-Related Progressive Multifocal Leucoencephalopathy (ANRS125) Enfuvirtide, Tenofovir-Emtricitabine - Leukoencephalopathy, Progressive Multifocal, HIV Infections | Phase 2 | Completed | French National Agency for Research on AIDS and Viral Hepatitis | 30 | 2005-04-01 | 2026-04-02 |
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Andreas Plettenberg, MD (1) · Andrew D Carr, MD (1) · Coleen Cunningham (1) · Colin Kovacs, MD (1) · Daniel R. Kuritzkes, MD (1) · David A Cooper, MD (1) · David M. Margolis, MD (1) · Dominique Costagliola (1) · Jacques Gasnault, MD (1) · Jordan Waypa, FNP (1) · Joseph Church (1)
PMID 12237598, PMID 14663459, PMID 15295220, PMID 16964830, PMID 18474492, PMID 18771056, PMID 18782780, PMID 20001856, PMID 21738597, PMID 23165467, PMID 24352352, PMID 26595748, PMID 31135883, PMID 32649866, PMID 34107771, PMID 34753870
2005 (2), P30AI094189 (1), R01AI045297 (1), R01AI064074 (1), R01HL065953 (1), R01MH058076 (1), R21AI055273 (1)