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
Antiretroviral therapy with a twice-daily regimen containing 400 milligrams of indinavir and 100 milligrams of ritonavir in human immunodeficiency virus type 1-infected women during pregnancy. Ghosn J, De Montgolfier I, Cornélie C, Dominguez S, Pérot C, Peytavin G, Marcelin AG, Pauchard M, Ouagari Z, Bonmarchand M, Agher R, Calvez V, Bricaire F, Dommergues M, Katlama C, Tubiana R. Antimicrob Agents Chemother. 2008 Apr;52(4):1542-4.
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.
Efficacy of a twice-daily antiretroviral regimen containing 100 mg ritonavir/400 mg indinavir in HIV-infected patients.Ghosn J, Lamotte C, Ait-Mohand H, Wirden M, Agher R, Schneider L, Bricaire F, Duvivier C, Calvez V, Peytavin G, Katlama C. AIDS. 2003 Jan 24;17(2):209-14.
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