amprenavir studies
Select the study ID number to view the trial summary
| Study ID | Phase | Title |
| ESS40011 | IV | A 24-week, Randomized, Open-Label, Multicenter Trial to Compare the Safety and Efficacy of the Licensed AGENERASE Dose (1200mg BID) to a Lower AGENERASE Dose (600mg BID) in the Presence of Norvir (100mg BID) when Combined with Other Background Antiretroviral Drugs in HIV-1 Infected Subjects. |
| WE066, EPI40007 | IV | The Antiretroviral Pregnancy Registry (APR, Registry) |
| COL30500 | III | An Open-Label, Single-Arm Study to Assess the Effect of Efavirenz (600mg QD) on Steady-State Plasma Amprenavir Pharmacokinetics Following Co-Administration with AGENERASE (1200mg QD), Ritonavir (300mg QD), Abacavir (300mg BID), and Lamivudine (150mg BID) in Adult HIV-Infected Subjects. |
| NIG-01-2000 | III | A compassionate use study to evaluate the safety and efficacy of COMBIVIR™ (lamivudine [LAM]150mg/zidovudine [ZDV] 300mg) tablets and AGENERASE™ (Amprenavir) (APV 150mg) capsules in human immunodeficiency (HIV) virus positive patients with CD4 cell count of 100 - 500/mm3 seen at Jos University Teaching Hospital , Jos, Lagos University Teaching Hospital Idi-Araba, Lagos and Ahmadu Bello University Teaching Hospital, Zaria |
| PRO30010 | III | Amprenavir (141W94) Open Label Protocol for Subjects with HIV-1 Infection Who Have Experienced Treatment Failure or Are Intolerant to Previous Protease Inhibitor Therapy. |
| PRO30011 | III | An Open-Label Study to Evaluate the Efficacy and Safety of Amprenavir (141W94) and Abacavir Combination Therapy in Protease Inhibitor-Experienced Subjects with HIV-1 Infection Who are Failing Their Current Antiretroviral Treatment Regimen. |
| PRO30012 | III | An Open-Label Study to Evaluate the Safety and Tolerance of Amprenavir (141W94) Combination Therapy in Protease Inhibitor Experienced Subjects Who Are Intolerant (Hyperlipidemia With or Without lipodystrophy) But Not Failing Their Current Protease Inhibitor Therapy |
| PRO30013 | III | Amprenavir (141W94) Open Label Study for Subjects with HIV infection who are Failing or are Intolerant to Previous Protease Inhibitor Therapy. |
| PRO30017A | III | A Phase III Randomised Multicentre Open-Label Study to Evaluate the Efficacy of AGENERASE (AGN; 600mg BID) in Combination with Low Dose Ritonavir (RTV; 100mg BID) Versus Other Protease Inhibitors (PIs) in HIV-Infected PI-Experienced Adults Over a 16 Week Period: Final Analyses of PRO30017 Sub-Study A. |
| PRO30017B | III | A Phase III randomised multicentre open-label study to evaluate the efficacy of AGENERASE (AGN; 600mg BID)/Ritonavir (RTV; 100mg BID) versus continued protease inhibitors (PIs) in HIV-1 Infected PI-experienced adults with evidence of HIV resistance to all approved PIs other than amprenavir: Final Analyses of PRO30017 Sub-Study B. |
| PROA1002 | III | The Pharmacokinetics and Pharmacodynamics of a Phase I/II Trial to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of Amprenavir After Multiple Dosing in Subjects With HIV Infection |
| PROAB3001 | III | A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination with RETROVIR and EPIVIR Compared to RETROVIR and EPIVIR Alone in Patients with HIV Infection |
| PROAB3004 | III | A Phase III, Open Label Trial to Evaluate the Safety, Antiviral Efficacy and Pharmacokinetics of 141W94 Plus Current Therapy in HIV-1 Infected Children. |
| PROAB3006 | III | A Phase III Trial to Compare the Safety and Antiviral Efficacy of 141W94 with Indinavir in Combination with Nucleoside Reverse Transcriptase Inhibitor (NRTI) Therapy in NRTI Experienced, Protease Inhibitor (PI) Naïve HIV-1 Infected Patients |
| PROAB3007 | III | An open-label phase III study to assess the long term safety profile of amprenavir (141W94) containing regimens in HIV infected subjects |
| PROF3020-AGIR | III | A pilot study to evaluate the efficacy and safety of a combination of antiretroviral drugs including amprenavir with or without ritonavir, two or three nucleoside analogs in HIV-1 infected patients who are in virological escape after a first, second or third line therapy including at least one protease inhibitor. |
| ESS40006 | II | A Phase II, Randomized, Open-Label Comparative, Pilot Study of Two Different Dosage Regimens of Amprenavir (600 mg BID vs. 900 mg BID) in Combination with Ritonavir (100 mg BID) Plus Abacavir, Another NRTI, and Either Efavirenz or Tenofovir DF in HIV-1 Infected Subjects with Virologic Evidence of Treatment Failure. |
| PROB2004 | II | A Phase II Trial to Assess the Preliminary Antiviral Effect, Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of APV Oral Solution in Combination with NRTIs in HIV Infected Children Below 13 Years Old |
| COL30330 | I | A Phase I, 13-Day, Controlled, Open-Label Pharmacokinetic Evaluation of Methadone Following Co-Administration with Amprenavir in Opiate-Dependent Subjects |
| PRO10017 | I | A Study to Investigate Whether There is a Pharmacokinetic Interaction Between Amprenavir and Ritonavir Following Their Co-Administration to Healthy Subjects. |
| PRO10018 | I | A Study to Investigate Whether There is a Pharmacokinetic Interaction Between Amprenavir and an Oral Contraceptive Following Their Co-Administration to Healthy Females. |
| PRO10022 | I | A Study to Investigate the Degree of Pharmacokinetic Interaction Between Amprenavir and Ritonavir Following Their Co-Administration to Healthy Subjects. |
| PRO10023 | I | A Study to Further Investigate the Degree of Pharmacokinetic Interaction Between Amprenavir and Ritonavir Following Their Co-Administration to Healthy Subjects. |
| PROA1001 | I | A Phase I Trial to Evaluate the Safety and Pharmacokinetics of 141W94 (Protease Inhibitor). |
| PROA1003 | I | A randomized cross-over study to evaluate the safety and pharmacokinetics of 141W94, zidovudine and lamivudine alone and in combination after single-dose administration in HIV-infected subjects. |
| PROA1005 | I | A Study to Investigate whether there is a Pharmacokinetic Interaction between 141W94 and Ketoconazole following their Co-Administration to Healthy Male Volunteers. |
| PROA1006 | I | A Phase I, Open-Label, Dose-Escalation Clinical Study to Assess the Pharmacokinetics and Tolerability of Single, Oral Doses of 141W94 in HIV-Infected Children. |
| PROA1007 | I | A mass balance study to investigate the metabolic disposition of a single, oral dose of radiolabelled [14C]-141W94 in healthy male subjects. |
| PROA1010 | I | A Phase I, Open-label, Randomized, Balanced, Three period, Cross-over Study to Assess the Bioequivalence of a New 150 mg Soft Gelatin 141W94 Capsule With a Reduced TPGS Content Relative to the Original High TPGS Content 150 mg Soft Gelatin Capsule and to Assess the Effect of Food Upon the Oral Bioavailability of the New Capsule in Healthy Male Subjects (Protocol PROA1010) |
| PROA1011 | I | A phase I, open-label, randomized, balanced, three period, cross-over study to assess the oral bioavailability of the new 50 and 150 mg soft gelatin capsules relative to the new 141W94 (amprenavir) oral solution in healthy male subjects. |
| PROA1012 | I | A Study to Investigate Whether There is a Pharmacokinetic Interaction Between 141W94 and Rifabutin and 141W94 and Rifampin Following Their Co-Administration to Healthy Male Volunteers. |
| PROA1013 | I | A Study to Investigate Whether There is a Pharmacokinetic Interaction Between 141W94 and Clarithromycin Following Their Co-Administration to Healthy Male Volunteers. |
| PROB1008 | I | A study to compare the pharmacokinetics of a single, oral, 600mg dose of amprenavir in healthy volunteers and patients with cirrhosis. |
| PROF1003 | I | A Study to Investigate the Pharmacokinetic Interaction Between Amprenavir and Ritonavir Following Their Co-Administration in Subjects with HIV-1 infection (PROF1003). |
| PROF1004 | I | A descriptive study to investigate the pharmacokinetic interaction between amprenavir and ritonavir following their co-administration in subjects with HIV-1 infection |