CLINICAL TRIALS PROFILE FOR ETRAVIRINE

All Clinical Trials for ETRAVIRINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00042289 ↗	Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy	Completed	National Institute of Allergy and Infectious Diseases (NIAID)		2003-03-01	The purpose of this study is to evaluate the pharmacokinetics (PKs) of antiretroviral (ARV) and tuberculosis (TB) medications in pregnant women and their infants. (Pharmacokinetics are the various interactions between a drug and the body.) This study will also evaluate the PKs of certain ARVs in postpartum women before and after starting hormonal contraceptives. The PKs of these drugs will be evaluated by measuring the amount of medicine present in blood and/or vaginal secretions.
NCT00128830 ↗	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	Completed	Tibotec Pharmaceuticals, Ireland	Phase 2	2005-06-01	The purpose of this study is to evaluate the long-term safety and tolerability of etravirine, administered as part of an individually optimized antiretroviral therapy (ART), in human immunodeficiency virus Type 1 (HIV-1) infected participants.
NCT00460382 ↗	Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses	Completed	Janssen-Cilag Tibotec	Phase 2	2007-05-01	The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.
NCT00460382 ↗	Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses	Completed	Merck Sharp & Dohme Corp.	Phase 2	2007-05-01	The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.
NCT00460382 ↗	Clinical Trial to Assess the Efficacy of Darunavir/Ritonavir (DRV/r), Etravirine (ETV) and Raltegravir (MK-0518) in HIV Patients With Resistant Viruses	Completed	French National Agency for Research on AIDS and Viral Hepatitis	Phase 2	2007-05-01	The purpose of this study is to look at the safety and efficacy of a combination of 3 new antiretroviral drugs: darunavir, etravirine and MK-0518 (raltegravir) in patients who have multi-resistant viruses and limited treatment options. An optimized background regimen that may include nucleoside reverse transcriptase inhibitors (NRTIs) and enfuvirtide can be added, if possible, to this combination. Patients will undergo treatment for 48 weeks and virological efficacy will be evaluated at week 24.
NCT00537394 ↗	Optimizing Treatment for Treatment-Experienced, HIV-Infected People	Completed	AIDS Clinical Trials Group	Phase 3	2008-01-01	The goal of anti-HIV therapy is to prevent HIV from replicating. Long-term control of HIV requires at least two anti-HIV drugs that are active against the virus. Drug resistance is a problem for many treatment-experienced, HIV-infected people. The purpose of this study was to determine the benefit of adding a nucleoside reverse transcriptase inhibitor (NRTI) to a new anti-HIV drug regimen for the suppression of HIV.

Clinical Trial Conditions for ETRAVIRINE

Condition Name

Condition Name for ETRAVIRINE
Intervention	Trials
HIV Infections	16
HIV	8
Infection, Human Immunodeficiency Virus	4
HIV-1	4

Condition MeSH

Condition MeSH for ETRAVIRINE
Intervention	Trials
HIV Infections	31
Acquired Immunodeficiency Syndrome	16
Immunologic Deficiency Syndromes	12
Infections	6

Clinical Trial Locations for ETRAVIRINE

Trials by Country

Trials by Country for ETRAVIRINE
Location	Trials
United States	180
South Africa	20
Canada	17
Brazil	15
Thailand	12

Trials by US State

Trials by US State for ETRAVIRINE
Location	Trials
Texas	15
New York	15
California	13
Florida	12
North Carolina	12

Clinical Trial Progress for ETRAVIRINE

Clinical Trial Phase

Clinical Trial Phase for ETRAVIRINE
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	8
Phase 2	12

Clinical Trial Status

Clinical Trial Status for ETRAVIRINE
Clinical Trial Phase	Trials
Completed	41
Terminated	5
Not yet recruiting	3

Clinical Trial Sponsors for ETRAVIRINE

Sponsor Name

Sponsor Name for ETRAVIRINE
Sponsor	Trials
ViiV Healthcare	9
GlaxoSmithKline	7
National Institute of Allergy and Infectious Diseases (NIAID)	5

Sponsor Type

Sponsor Type for ETRAVIRINE
Sponsor	Trials
Industry	56
Other	37
NIH	6