Recent Updates
Recently added Catalysts

Indinavir

Phase 3FDA approved

HIV Infections | Small molecule | Infectious Disease |Merck & Company, Inc.|Trials Updated: Jun 24, 2005

Indinavir development status

FDA approval on record Feb 6, 1998 as Crixivan
Approval holderMerck Sharp Dohme
ApplicationNDA020685
Highest phase Phase 3
Registered trials 1 across 1 sponsor since Nov 1999

Indinavir target and mechanism

ModalitySmall molecule

Also known as Indinavir sulfate

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials6
Total Enrollment918

FDA Designations

No designations recorded

Indinavir clinical trials

Indinavir · 6 trials · 1 indication

Phase 3 3Phase 2 2Phase 1 1
NCT00002208A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TCHIV Infections
COMPLETED400 Analytics
NCT00002220Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With NelfinavirHIV Infections
COMPLETED120 Analytics
NCT00002406A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected PatientsHIV Infections
COMPLETED350 Analytics
PHASE3COMPLETED
A Multicenter, Open-Label, Randomized, 24-Week Study to Compare the Safety and Activity of Indinavir Sulfate, 800 Mg q 8 h Versus 1,200 Mg q 12 h in Combination With Zidovudine and 3TC
HIV InfectionsUnlock trial analytics
PHASE3COMPLETED
Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir
HIV InfectionsUnlock trial analytics
PHASE3COMPLETED
A Comparison of Two Dose Levels of Indinavir Combined With Two Nucleoside Analogue Reverse Transcriptase Inhibitors (NRTIs) in HIV-Infected Patients
HIV InfectionsUnlock trial analytics

Study Design & Arms

PurposeTREATMENT

Interventions

NameTypeDescription
Indinavir sulfateDRUG -
LamivudineDRUG -
StavudineDRUG -
ZidovudineDRUG -
EfavirenzDRUG -
LevocarnitineDRUG -
Adefovir dipivoxilDRUG -
Nelfinavir mesylateDRUG -
RitonavirDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria Patients must have: * HIV-1 seropositive status. * CD4 count greater than 100 cells/mm3. * Viral RNA above 10,000 copies/mL. * Consent from parent or guardian if less than 18 years of age. Exclusion Criteria Prior Medication: Excluded: * Prior therapy with protease inhibitor...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Indinavir

What is Indinavir used for?

Indinavir is used to treat HIV Infections. It is an antiretroviral medicine studied in adults, adolescents, and children living with HIV, including patients who had failed prior protease inhibitor treatment. It has been evaluated both as part of combination regimens and at different dose levels alongside nucleoside analogue reverse transcriptase inhibitors.

Who makes Indinavir?

Indinavir is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor responsible for the clinical development program of the drug in HIV Infections.

What phase is Indinavir in?

Indinavir has been studied in Phase 3 clinical development for HIV Infections. Its trial program also includes Phase 2 and Phase 1 studies. The Phase 3 study compared two dose levels of Indinavir combined with two nucleoside analogue reverse transcriptase inhibitors in HIV-infected patients.

What clinical trials is Indinavir in?

Indinavir has been evaluated in six completed clinical trials, including NCT00002406, a Phase 3 comparison of two dose levels with two nucleoside analogue reverse transcriptase inhibitors, and NCT00002361, a Phase 2 study in patients who had failed prior protease inhibitor treatment. Other studies include NCT00002351 and NCT00002235.

Is Indinavir the same as Indinavir sulfate?

Yes, Indinavir sulfate is another name for Indinavir. The two names refer to the same medicine, so searches for either term describe the same HIV treatment developed by Merck & Company, Inc.

How many patients have been enrolled in Indinavir trials?

Across six completed clinical trials, 918 patients have been enrolled in studies of Indinavir for HIV Infections. The largest of these, NCT00002406, enrolled 350 participants, while the smallest, NCT00002235, enrolled 6.