TMC125HIV1083 - Swallowability of Uncoated 200 mg Etravirine Tablets in HIV-1 Infected Patients
NCT01090648 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49
Last updated 2012-12-11
Summary
This trial is designed to assess the swallowability of uncoated and film-coated 200 mg etravirine tablets in HIV-1 infected patients. In addition, comparisons between a single 200 mg tablet versus two 100 mg formulations will be made. The outcome of the trial will aid in making decisions about the future commercial 200 mg formulation.
Conditions
- HIV-Infections
Interventions
- DRUG
-
etravirine
One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet
Sponsors & Collaborators
-
Tibotec Pharmaceuticals, Ireland
lead INDUSTRY
Principal Investigators
-
Tibotec Pharmaceuticals Clinical Trial · Tibotec Pharmaceutical Limited
Study Design
- Allocation
- NON_RANDOMIZED
- Masking
- SINGLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-03-31
- Primary Completion
- 2010-05-31
- Completion
- 2010-05-31
More Related Trials
-
TMC125-C216: A Phase III Study to Investigate the Efficacy, Tolerability and Safety of TMC125 as Part of an Antiretroviral Regimen, Including TMC114/Ritonavir and an Investigator-selected Optimized Background, in HIV-1 Infected Patients With Limited to no Treatment Options.
NCT00255099 ·Status: COMPLETED ·Phase: PHASE3
-
TMC125-C223: TMC125 in HIV-1 Infected Subjects
NCT00081978 ·Status: COMPLETED ·Phase: PHASE2
-
An Open Label Trial of TMC114/RTV in HIV-1 Infected, Treatment-experienced Subjects.
NCT00081588 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Long-term Safety and Tolerability of TMC114/Rtv in HIV-1 Infected Participants After Rolling-over From Other TMC114 Trials
NCT02187107 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate Safety, Acceptability, Pharmacokinetics, and ex Vivo Pharmacodynamics of TMC278 Long Acting Formulation in HIV-1 Seronegative Participants
NCT01656018 ·Status: COMPLETED ·Phase: PHASE1
-
TMC114-C226: An Early Access Program to Evaluate the Long-term Safety and Tolerability of TMC114 Combined With a Low Dose of Ritonavir (TMC114/r) With Other Antiretrovirals, for HIV-1 Infected Patients Who Have Failed Multiple Antiretroviral Regimens.
NCT00245739 ·Status: APPROVED_FOR_MARKETING
-
TMC125-C203: Phase II Randomized (Patients Are Assigned Different Treatments Based on Chance), Placebo Controlled Dose Escalating Trial of TMC125 in HIV-1 Infected Patients
NCT00412646 ·Status: COMPLETED ·Phase: PHASE2
-
TMC114-C227: A Study to Evaluate the Effectiveness and Safety of TMC114 (Darunavir) With a Low Dose of Ritonavir as Monotherapy (no Other Anti-HIV Drugs Will be Given) in Patients Who Have Never Been Treated With Antiretrovirals (Anti-HIV Drugs) Previously
NCT00513513 ·Status: TERMINATED ·Phase: PHASE2
-
TMC278-TiDP15-C158 - A Study to Examine the Safety, Tolerability and Pharmacokinetics of a Single Dose or Three Successive Doses of Intramuscularly (IM) Injected Long Acting Formulation of TMC278
NCT01031589 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of TMC278 in Human Immunodeficiency Virus Type 1 Infected Patients, Who Are Not Treated With Antiretroviral Medicines
NCT00110305 ·Status: COMPLETED ·Phase: PHASE2
-
TMC125-C227: A Phase II Randomized, Active-Controlled, Open Label Trial to Investigate the Efficacy and Tolerability of TMC125 in HIV-1 Infected Subjects, Who Are PI-Naive and With Documented Genotypic Evidence of NNRTI Resistance From Previous NNRTI Use
NCT00225303 ·Status: COMPLETED ·Phase: PHASE2
-
TMC278-TiDP38-C145: A Bioavailability Study in Healthy Adult Volunteers to Evaluate 3 Pediatric Formulations of TMC278 (a Solution, a Suspension, and Granules) Compared to an Adult Tablet Formulation
NCT00812292 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate the Pharmacokinetics, Safety, Tolerability, and Antiviral Activity of Rilpivirine (TMC278) in Human Immunodeficiency Virus Infected Adolescents and Children Aged Greater Than or Equal to 6 Years
NCT00799864 ·Status: COMPLETED ·Phase: PHASE2
-
A Proof of Concept Study to Evaluate the Antiviral Activity, Safety, and Pharmacokinetics of the CCR5 Antagonist TBR 652 in HIV 1-Infected, Antiretroviral Treatment-Experienced, CCR5 Antagonist-Naïve Patients
NCT01092104 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
TMC114-C213: A Phase II Randomized, Controlled, Partially Blinded Trial to Investigate Dose-response of TMC114/RTV in 3-class-experienced HIV-1 Infected Patients, Followed by an Open-label Period on the Recommended Dose of TMC114/RTV.
NCT00650832 ·Status: COMPLETED ·Phase: PHASE2
-
Study in Healthy Volunteers of the Safety and Metabolism of Different Doses of the Anti-HIV Drug TMC278LA.
NCT01275443 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I, Open-label Trial to Explore the Pharmacokinetics, Safety and Tolerability of TMC278 (Rilpivirine) 25 mg Once Daily Following a 2-week Period Receiving Efavirenz, in Healthy Male and Female Volunteers
NCT01268839 ·Status: COMPLETED ·Phase: PHASE1
-
An Open-label Trial With TMC125 in Patients Who Have Virologically Failed in a DUET Trial (TMC125-C206 or TMC125-C216).
NCT00359021 ·Status: COMPLETED ·Phase: PHASE3
-
TMC114-C201: A Study to Determine the Antiviral Activity of TMC114 in Patients With Multiple Protease Inhibitor (PI) Resistant Human Immunodeficiency Virus (HIV) Strains
NCT00964327 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Suspension Injection of Investigational Capsid Inhibitors Compared to Placebo in Healthy Adults
NCT06012136 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Etravirine Administered in Combination With Other Antiretroviral Agents in Antiretroviral Treatment-Experienced HIV-1 Infected Patients
NCT01422330 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Anti-HIV Activity of Capravirine Alone and in Combination With Other Anti-HIV Drugs
NCT00005673 ·Status: COMPLETED ·Phase: PHASE1
-
TMC125IFD1001 - Drug-Drug Interaction of Etravirine With Telaprevir and TMC278 With Telaprevir.
NCT01336829 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of 141W94 Used Alone or in Combination With Zidovudine Plus 3TC in HIV-Infected Patients
NCT00001085 ·Status: COMPLETED ·Phase: PHASE2
-
A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC
NCT00002208 ·Status: COMPLETED ·Phase: PHASE3