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Isentress

Phase 3

HIV Infections | Small molecule | Infectious Disease |Merck & Company, Inc.|Last Updated: May 12, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedNO_TREATMENT_CONTROLLEDBiomarker
Total Trials1
Total Enrollment17

FDA Designations

No designations recorded

Clinical trial landscape

Isentress · 1 trial · 1 indication

Phase 3 1
NCT00935480IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected PatientsHIV Infections
COMPLETED17 Analytics
PHASE3COMPLETED
IntensVIH: Impact Of Therapy Intensification By An Integrase Inhibitor +/- CCR5 Inhibitor On The Lymphoid Reservoir For Hiv-1 In Chronically Infected Patients
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

residual plasma replication between 0 and 50 copies/ml
one year
intracellular HIV RNA levels in circulating lymphocytes (PBMC) and lymphocytes in gut-associated rectal lymphoid tissue (RL
one year
proviral HIV DNA levels in PBMC and RL
one year

Secondary Endpoints

CD4 counts
one year
CD8 activation levels
one year
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HAART+Raltegravir 12 months (+/-) MaravirocEXPERIMENTAL -
HAARTNO_INTERVENTION -

Interventions

NameTypeDescription
Isentress®DRUGP.O, 1 tablet containing 400 mg every 12 hours
Celsentri®DRUGp.o.: 1 tablet containing 150 mg morning and evening (due to combination with PI/r) or containing 300 mg if fosamprenavir/r is used as the PI (MA)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female patients, aged over 18 years * HIV infection confirmed by Western Blot * Karnofsky score \> 80% * Treatment-experienced patients having received combined antiretroviral therapy including at least 2 RTI and 1 PI/r for at least 12 months with plasma viral load \<5...

Countries:France
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Frequently asked questions about Isentress

What is Isentress used for in HIV Infections?

Isentress is an investigational small molecule being studied for the treatment of HIV Infections. It is being evaluated in a Phase 3 clinical trial to assess the impact of therapy intensification on the lymphoid reservoir for HIV-1 in chronically infected patients. The drug is not yet approved and remains in clinical development.

Who makes Isentress?

Isentress is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical research on this small molecule for the treatment of HIV Infections, with the drug currently in Phase 3 development.

What phase is Isentress in?

Isentress is in Phase 3 clinical development for HIV Infections. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy in patients.

What clinical trials is Isentress in?

Isentress is being studied in one completed Phase 3 clinical trial with the identifier NCT00935480. This trial, titled IntensVIH, enrolled 17 participants in France and evaluated the impact of therapy intensification by an integrase inhibitor on the lymphoid reservoir for HIV-1 in chronically infected patients.

Is Isentress the same as raltegravir?

Isentress is the brand name for the drug raltegravir, an integrase inhibitor used in the treatment of HIV Infections. The clinical trial NCT00935480 refers to therapy intensification by an integrase inhibitor, which corresponds to the mechanism of action of raltegravir, the active ingredient in Isentress.