Recent Updates
Recently added Catalysts

ritonavir

Phase 4FDA approved

HIV Infections | Small molecule | Infectious Disease |Abbott Laboratories|Trials Updated: Feb 20, 2009

ritonavir development status

FDA approval on record Jun 29, 1999 as Norvir
Approval holderAbbvie
ApplicationNDA020945
Highest phase Phase 4 run by ViiV Healthcare (NCT00717067)
Phase scored for ABTPhase 3
Registered trials 176 across 34 sponsors since Nov 1999

ritonavir target and mechanism

Molecular targetCYP3A4, CYP3A5, CYP3A43, CYP3A7
Target classInhibitor
ModalitySmall molecule
ChEMBLCHEMBL163

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials2
Total Enrollment36

FDA Designations

No designations recorded

ritonavir clinical trials

ritonavir · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00038636A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase InhibitorsHIV Infections
COMPLETED36 Analytics
PHASE3COMPLETED
A Study of Two Different Doses of ABT-378/Ritonavir in HIV-Infected Patients Who Have Taken Protease Inhibitors and Non-Nucleoside Reverse Transcriptase Inhibitors
HIV InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Virologic and immunologic activity evaluations include plasma HIV RNA, CD4 and CD8 cell counts
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Lopinavir/ritonavirDRUG -
RitonavirDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion: * HIV positive * Are at least 18 years old * Subject has not been treated for an active AIDS-defining opportunistic infection within 15 days of screening * HIV RNA level \> 1000 copies/mL * Previous therapy with at least one protease inhibitor, at least one non-nucleoside reverse transcr...

Countries:United StatesFranceSpainAustralia
Unlock Eligibility Criteria

Frequently asked questions about ritonavir

What is ritonavir used for?

Ritonavir is used to treat HIV infections and has also been studied in HIV-related Kaposi's sarcoma. It is a small molecule antiviral developed by Abbott Laboratories. In HIV therapy it is commonly used as a pharmacokinetic booster alongside other protease inhibitors rather than as a standalone treatment.

What does ritonavir target?

Ritonavir targets the cytochrome P450 3A enzymes CYP3A4, CYP3A5, CYP3A43, and CYP3A7, acting as an inhibitor. By inhibiting these enzymes it slows the metabolism of co-administered protease inhibitors, raising their blood levels. This boosting effect is the basis for its role in combination HIV regimens.

Who makes ritonavir?

Ritonavir is developed and manufactured by Abbott Laboratories, which trades under the ticker ABT. Abbott is the sponsor behind the clinical development program for the drug, including the Phase 3 study of ABT-378/ritonavir in HIV-infected patients.

What phase is ritonavir in?

Ritonavir has been studied in Phase 3 clinical development, with a Phase 3 trial in HIV-infected patients and a Phase 2 trial in HIV-related Kaposi's sarcoma. Both studies are listed as completed, and no trials are currently active in this dataset.

What clinical trials is ritonavir in?

Two completed trials are registered for ritonavir. NCT00038636 was a Phase 3 randomized study of two doses of ABT-378/ritonavir in HIV-infected patients previously treated with protease inhibitors and non-nucleoside reverse transcriptase inhibitors, enrolling 36 patients across the United States, France, and Spain. NCT00002366 was a Phase 2 study of ritonavir in HIV-related Kaposi's sarcoma in Australia.

Is ritonavir approved by the FDA?

Ritonavir is an established HIV treatment that has been used in clinical practice, and its development program includes completed Phase 3 and Phase 2 trials. The trials registered here are listed as completed, with the Phase 3 study evaluating ABT-378/ritonavir in previously treated HIV-infected patients.