CRIXIVAN SUMMARY
CRIXIVAN (indinavir sulfate) is an inhibitor of the human immunodeficiency virus (HIV) protease. CRIXIVAN Capsules are formulated as a sulfate salt and are available for oral administration in strengths of 100, 200, 333, and 400 mg of indinavir (corresponding to 125, 250, 416.3, and 500 mg indinavir sulfate, respectively).
CRIXIVAN in combination with antiretroviral agents is indicated for the treatment of HIV infection.
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NEWS HIGHLIGHTS
Published Studies Related to Crixivan (Indinavir)
Indinavir-loaded pH-sensitive microparticles for taste masking: toward extemporaneous pediatric anti-HIV/AIDS liquid formulations with improved patient compliance. [2009]
The aim of this work was to develop indinavir pediatric anti-HIV/AIDS formulations enabling convenient dose adjustment, ease of oral administration, and improved organoleptic properties by means of the generation of drug-loaded microparticles made of a polymer that is insoluble under intake conditions and dissolves fast in the stomach in order to completely release the active agent...
Effect of omeprazole on the plasma concentrations of indinavir when administered alone and in combination with ritonavir. [2008.03.01]
PURPOSE: The effects of omeprazole on indinavir when administered alone or in combination with ritonavir were evaluated... CONCLUSION: The AUC of indinavir was substantially decreased in healthy volunteers who received omeprazole 20 or 40 mg daily for seven days before the administration of a single 800-mg dose of indinavir. Concomitant administration of ritonavir 200 mg with indinavir in participants receiving omeprazole led to a significant increase in the AUC of indinavir.
Association of efavirenz hypersusceptibility with virologic response in ACTG 368, a randomized trial of abacavir (ABC) in combination with efavirenz (EFV) and indinavir (IDV) in HIV-infected subjects with prior nucleoside analog experience. [2008.01]
CONCLUSION: Premature treatment discontinuations in the ABC arm and the presence of EFV-HS HIV variants in this patient population likely made it difficult to detect a benefit of adding ABC to EFV+IDV. In addition, L74V, when combined with K103N+L100I, may confer a selective advantage to the virus that is independent of its effects on nucleoside resistance.
Lack of indinavir-associated nephrological complications in HIV-infected adults (predominantly women) with high indinavir plasma concentration in Abidjan, Cote d'Ivoire. [2007.01]
To report the tolerance of indinavir combined with ritonavir (IDV/r 800/100 mg) twice daily (bid) in sub-Saharan African HIV-infected adults... There was a surprising lack of nephrological side effects during the 6 months of follow-up, supporting the hypothesis that nephrological tolerance of IDV might be higher in sub-Saharan African individuals than in Americans or Europeans.
Pharmacogenetic characteristics of indinavir, zidovudine, and lamivudine therapy in HIV-infected adults: a pilot study. [2006.08.01]
OBJECTIVE: The aim of the study was to investigate relationships among indinavir, lamivudine-triphosphate, and zidovudine-triphosphate pharmacokinetics and pharmacodynamics with polymorphisms in CYP3A5, MDR1, MRP2, MRP4, BCRP, and UGT1A1 genes. STUDY DESIGN: Retrospective pilot investigation among 33 subjects who participated in a randomized pharmacological study of indinavir, lamivudine, and zidovudine...
Clinical Trials Related to Crixivan (Indinavir)
A Six-Month Safety and Antiviral Study in HIV-1 Seropositive, AZT-Experienced Patients With CD4 Counts Less Than or Equal to 50 Cells/mm3 to Evaluate MK-639 Alone Versus Zidovudine (AZT) and 3TC Versus the Combination of MK-639 With AZT/3TC [Completed]
A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir [Completed]
The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with
indinavir and if it works well at lowering the level of HIV in the blood (viral load).
A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients [Completed]
The purpose of this study is to determine how many HIV-infected patients continue taking
ritonavir/indinavir combination after having taken indinavir three times a day as part of
their anti-HIV drug therapy. This study also examines the safety and effectiveness of the
ritonavir/indinavir combination.
A Study on the Safety and Effectiveness of Twice-Daily Nelfinavir Plus Twice-Daily Indinavir Plus Efavirenz in HIV-Positive Patients Who Have Never Taken Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) or Protease Inhibitors [Completed]
Indinavir is usually taken three times a day. The purpose of this study is to see if it is
safe and effective to take indinavir only twice a day plus nelfinavir (also taken twice a
day) and efavirenz (taken once a day).
The Safety and Effectiveness of Indinavir Sulfate Plus Efavirenz [Completed]
To estimate the differences in parameters of antiviral activity and safety between a control
regimen of indinavir in combination with DMP 266 and an experimental regimen of higher-dose
indinavir in combination with lower-dose DMP 266 after sixteen weeks of dosing, in protease
inhibitor- and non-nucleoside reverse transcriptase inhibitor-naive, HIV-1 seropositive
patients.
It is hypothesized that after 16 weeks of randomized treatment with either the control or
experimental regimen that:
1. The observed proportion of patients with serum viral RNA < 400 copies/ml in the
experimental and control regimen will be similar and will continue to be so after 48
weeks.
2. The safety profiles of the two groups will be similar, judged by the incidence of
serious, drug-related adverse experiences and the incidence of events of specific
interest (e. g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and
CNS-related symptoms) and will continue to be so after 48 weeks.
3. The two groups will be similar with respect to changes from baseline in serum viral RNA
and CD4 counts and will continue to be so after 48 weeks.
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