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Amprenavir/ritonavir

Phase 2

HIV Infections | Small molecule | Infectious Disease |Abbott Laboratories|Last Updated: Apr 1, 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials2
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Amprenavir/ritonavir · 2 trials · 1 indication

Phase 2 2
NCT00038519Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease InhibitorHIV Infections
COMPLETED16 Analytics
NCT00038532Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAARTHIV Infections
COMPLETED24 Analytics
PHASE2COMPLETED
Amprenavir/Ritonavir or Saquinavir/Ritonavir in HIV-Infected Subjects Following Failure With Kaletra as Their Second Protease Inhibitor
HIV InfectionsUnlock trial analytics
PHASE2COMPLETED
Amprenavir/Ritonavir, Saquinavir/Ritonavir or Efavirenz in HIV-Infected Subjects Following Failure With Kaletra (ABT-378/Ritonavir) as Their First Protease Inhibitor Based HAART
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of subjects with plasma HIV RNA levels below the limit of quantification (400 copies/mL) at week 24 and the time until loss of virologic response through week 48
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Amprenavir/ritonavirDRUG -
Saquinavir/ritonavirDRUG -
EfavirenzDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites52

Inclusion: * Subject must remain on current antiretroviral therapy during screening until a new regimen is initiated. * Subject demonstrates reduced susceptibility to lopinavir. * Subject's two most recent viral loads obtained after at least 16 weeks of lopinavir/ritonavir therapy, and while still ...

Countries:United StatesArgentinaBrazilCanadaFranceItalyPolandPuerto RicoSpainUnited KingdomGermany
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Frequently asked questions about Amprenavir/ritonavir

What is Amprenavir/ritonavir used for?

Amprenavir/ritonavir is an investigational small molecule combination being studied for the treatment of HIV infections. It is in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated in HIV-infected patients who have experienced failure with prior protease inhibitor-based therapy.

Who makes Amprenavir/ritonavir?

Amprenavir/ritonavir is being developed by Abbott Laboratories, which trades under the ticker ABT. The company is conducting clinical trials to evaluate the combination in patients with HIV infections who have failed prior protease inhibitor-based regimens.

What phase is Amprenavir/ritonavir in?

Amprenavir/ritonavir is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 2 trials have been completed, with a total enrollment of 40 patients, both studying the drug in HIV-infected subjects.

What clinical trials is Amprenavir/ritonavir in?

Amprenavir/ritonavir has been studied in two completed Phase 2 trials: NCT00038519 and NCT00038532. Both trials enrolled HIV-infected adults who had failed prior protease inhibitor-based therapy, with enrollment of 16 and 24 patients respectively. The trials were conducted across multiple countries including the United States, Argentina, Brazil, and several European nations.

How does Amprenavir/ritonavir work?

Amprenavir/ritonavir is a combination of two protease inhibitors used to treat HIV infections. The combination is designed to enhance the activity of amprenavir by using ritonavir to boost its levels in the body, potentially improving antiviral efficacy in patients who have failed prior protease inhibitor therapy.