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]
Treatment With Indinavir and Chemotherapy for Advanced Classical Kaposi's Sarcoma [Recruiting]
The purpose of this study is to determine the clinical response to daily Indinavir oral
administration in association with a conventional chemotherapy based on cycles of systemic
Vinblastine +/- Bleomycin in patients affected by advanced classical (non HIV-associated)
Kaposi's sarcoma
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.
External-Beam Radiation Therapy With or Without Indinavir and Ritonavir in Treating Patients With Brain Metastases [Recruiting]
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Indinavir and
ritonavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell
growth. It is not yet known whether external-beam radiation therapy is more effective with
or without indinavir and ritonavir in treating patients with brain metastases.
PURPOSE: This randomized phase II trial is studying external-beam radiation therapy alone to
see how well it works compared to external-beam radiation therapy given together with
indinavir and ritonavir in treating patients with brain metastases.
Reports of Suspected Crixivan (Indinavir) Side Effects
Pulmonary Hypertension (3),
Palpitations (3),
Dizziness (3),
Death (2),
T-Lymphocyte Count Decreased (2),
Dementia (1),
Pain (1),
Drug Interaction (1),
Hemiparesis (1),
Pupils Unequal (1), more >>
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