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LPV/r+2 NRTIs

Phase 3

HIV Infections | Small molecule | Infectious Disease |Bristol-Myers Squibb Company|Last Updated: Feb 5, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment192

FDA Designations

No designations recorded

Clinical trial landscape

LPV/r+2 NRTIs · 1 trial · 1 indication

Phase 3 1
NCT00120393Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/RitonavirHIV Infections
COMPLETED192 Analytics
PHASE3COMPLETED
Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir
HIV Infections
NCT00120393192
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Study Endpoints

Primary Endpoints

To compare the Week 12 percent change from baseline in fasting non-HDL cholesterol between subjects who are switched to an ATV/RTV-containing regimen and those who continue on a LPV/RTV based regimen.

Secondary Endpoints

Mean percent change in fasting non-HDL cholesterol at Weeks 24 and 48.
Mean change in cholesterol measures at Weeks 12, 24 and 48.
Mean percent changes from baseline in fasting glucose and insulin at Weeks 12, 24 and 48.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
G1ACTIVE_COMPARATOR -
G2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
atazanavir/ritonavir +2 NRTIs (immediate Switch Group)DRUGCapsules, Oral, ATV 300mg/RTV 100mg + 2 NRTIs, QD, 48 weeks.
LPV/r +2 NRTIs (Delayed/optional Switch Group)DRUGCapsules, Oral, LPV 400mg/RTV 100mg +2 NRTIs, BID, 24 weeks then option to switch to ATV arm or stay until 48 weeks.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * HIV positive * LPV/RTV-based HAART for at least 6 months * HIV-1 RNA less than 50c/mL (confirmed) * Non-HDL higher than 160 mg/dL * CD4 of at least 50 cells/mL Exclusion Criteria: * Use of lipid-lowering agents

Countries:United StatesCanada
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Competitive Landscape -Bacterial Infections 61 trials (matched to "HIV Infections")

Top 20 of 28 competitors

CompanyTickerTrialsLead PhaseDrugs
Pfizer Inc.PFE5PHASE3VLA15
Sanofi SA Sponsored ADRSNY2PHASE3PCV21, 20vPCV
GSK plc Sponsored ADRGSK4PHASE2MenABCWY vaccine
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
CorMedix Inc.CRMD2PHASE3catheter lock, Heparin
Sinovac Biotech Ltd.SVA4PHASE3Sinovac PCV13, Prevnar
Novartis AG Sponsored ADRNVS1PHASE2Cryptosporidium parvum oocysts, EDI048
Innoviva, Inc.INVA3PHASE2Eravacycline/kg
BiomX Inc.PHGE1PHASE2BX004
Merck & Co., Inc.MRK2PHASE1V118C, PCV20
ICON PlcICLR1PHASE2AV7909 Full Dose, AV7909 Half Dose
AstraZeneca PLCAZN1PHASE1AZD7760
BioNTech SE Sponsored ADRBNTX1PHASE1BNT163
60 Degrees Pharmaceuticals, Inc.SXTP1PHASE2Tafenoquine
Tarsus Pharmaceuticals, Inc.TARS1PHASE2TP-05 Low Dose
Moderna, Inc.MRNA1PHASE2mRNA-1982
AN2 Therapeutics, Inc.ANTX1PHASE2Epetraborole
Emergent BioSolutions Inc.EBS4 - AIGIV
Abbott LaboratoriesABT1N/AUndisclosed
CareDx, Inc.CDNA1 - Undisclosed
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Frequently asked questions about LPV/r+2 NRTIs

What is LPV/r+2 NRTIs used for?

LPV/r+2 NRTIs is a combination regimen used for HIV Infections. It consists of lopinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors. This regimen was studied in a Phase 3 clinical trial in patients with HIV and undetectable viral load who had abnormal lipids.

Who makes LPV/r+2 NRTIs?

LPV/r+2 NRTIs is developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company conducted a Phase 3 clinical trial of this regimen in patients with HIV infections.

What phase is LPV/r+2 NRTIs in?

LPV/r+2 NRTIs is in Phase 3 clinical development. It is an investigational regimen for HIV Infections and is not approved by the FDA. The Phase 3 trial has been completed, with 192 patients enrolled.

What clinical trials is LPV/r+2 NRTIs in?

LPV/r+2 NRTIs was studied in one completed Phase 3 clinical trial, NCT00120393, titled 'Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir'. The trial enrolled 192 participants in the United States and Canada.

Is LPV/r+2 NRTIs the same as Atazanavir/Ritonavir?

No, LPV/r+2 NRTIs is not the same as Atazanavir/Ritonavir. The clinical trial NCT00120393 studied patients switching to Atazanavir/Ritonavir, but LPV/r+2 NRTIs refers to a regimen of lopinavir/ritonavir plus two nucleoside reverse transcriptase inhibitors. These are distinct drug combinations.