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Raltegravir

Phase 1

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Feb 4, 2010

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

Raltegravir · 1 trial · 1 indication

Phase 1 1
NCT00518297DDI HV (ATV - Merck)HIV Infections
COMPLETED22 Analytics
PHASE1COMPLETED
DDI HV (ATV - Merck)
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety Assessments
Screening, Days -1, 1, 5, 6, 8, 10, 12, 13, 15, 19, 22, 26, and Study Discharge
Pharmacokinetic Assessments
Days 5, 12, and 26
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATOR -
2ACTIVE_COMPARATOR -
3ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
RaltegravirDRUGTablet, Oral, 400 mg, twice daily for 5 Days
AtazanavirDRUGCapsule, Oral, 300 mg, twice daily for 7 Days
Atazanavir + RaltegravirDRUGCapsule/Tablet, Oral, 300/400, twice daily for 14 Days
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female subjects between the ages of 18 to 45 years old with a body mass index (BMI) of 18 to 32 kg/m² * Prior to enrollment, subjects must have physical and laboratory test findings within normal limits, and women of childbearing potential (WOCBP) must have a ...

Countries:United States
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Frequently asked questions about Raltegravir

What is Raltegravir used for in HIV Infections?

Raltegravir is an investigational small molecule being studied for the treatment of HIV Infections. It is currently in Phase 1 clinical development. The drug is being evaluated in a clinical trial with healthy volunteers to assess its effects, though it has not yet been approved for any use.

Who makes Raltegravir?

Raltegravir is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY. The company is conducting clinical research on this small molecule for the treatment of HIV Infections, and the drug is currently in Phase 1 development.

What phase is Raltegravir in?

Raltegravir is in Phase 1 clinical development. It is an investigational drug for HIV Infections and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical research.

What clinical trials is Raltegravir in?

Raltegravir has one completed clinical trial, NCT00518297, titled "DDI HV (ATV - Merck)". This Phase 1 study enrolled 22 participants in the United States and was an active-controlled trial involving healthy volunteers aged 18 years and older. The trial is no longer active.

Is Raltegravir the same as any other drug?

Raltegravir is a distinct investigational drug being developed by Bristol-Myers Squibb Company. No alternative names for Raltegravir have been reported in the clinical trial information. It is being studied specifically for HIV Infections and is currently in Phase 1 development.