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CRIXIVAN (Indinavir)

 

Clinical Trials   Review Articles   Adverse Effects   FDA Information   Manufacturer

Comments

Indinavir, a protease inhibitor, received FDA approval in 1996 for use in adults with HIV infection. Long-term clinical data support its durability and potency. In addition, multiple mutations are required for resistance. It is not widely used nowadays because of better alternatives. However, indinavir remains a good choice in resource-limited settings due to its excellent efficacy and low cost.  

 

Indinavir is an inhibitor of cytochrome P450 3A4 (CYP3A4), and may alter serum concentrations of other drugs metabolized by this pathway. Additionally, indinavir is also metabolized by CYP3A4, drugs that affect this enzyme system, such as rifampin, and rifabutin, may significantly affect indinavir levels. Several protease inhibitors and the nonnucleoside reverse transcriptase inhibitors also affect indinavir concentrations. 

 

Indinavir should be taken on an empty stomach or with a light snack, but not within 1 hour before or 2 hours after a full meal. Combination with low-dose ritonavir allows less-frequent dosing of indinavir and elimination of food restrictions. The most common adverse effects associated with indinavir are nephrolithiasis, asymptomatic hyperbilirubinemia and hepatitis. Nephrolithiasis can be prevented with adequate hydration of at least 1.5 liters of liquids daily. No dose adjustment is necessary in renal insufficiency.

 

Clinical Trials   

Antiretroviral therapy

The Indinavir/ritonavir (IDV/r) 400/100 mg BID regimen demonstrats its efficacy in the prevention of mother-to-child transmission and costs about 50% less than the standard IDV regimen.

 

Indinavir/ritonavir 400/100 mg BID provides the same efficacy as 800/100 mg BID but better safety and tolerance.

 

Indinavir/ritonavir (IDV/r) 400/100 mg BID yields better parmacholinetic profiles than the standard IDV regimen and results in excellent tolerability and similar efficacy.

 

Review Articles

Due to its low cost and proven efficacy, indinavir remains a key component of HIV/AIDS treatment in resource-limited settings.

 

The application of ritonavir-boosted indinavir administered at lower doses in resource-constrained settings is an attractive option.

 

A comprehensive review of renal disease in HIV-positive patients.

 

Adverse Drug Reactions and Warnings

 

FDA Information

 

Manufacturer/Distributor Product Information

USA

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