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Vistide (Cidofovir) - Summary

 
 



WARNING

RENAL IMPAIRMENT IS THE MAJOR TOXICITY OF VISTIDE. CASES OF ACUTE RENAL FAILURE RESULTING IN DIALYSIS AND/OR CONTRIBUTING TO DEATH HAVE OCCURRED WITH AS FEW AS ONE OR TWO DOSES OF VISTIDE. TO REDUCE POSSIBLE NEPHROTOXICITY, INTRAVENOUS PREHYDRATION WITH NORMAL SALINE AND ADMINISTRATION OF PROBENECID MUST BE USED WITH EACH VISTIDE INFUSION. RENAL FUNCTION (SERUM CREATININE AND URINE PROTEIN) MUST BE MONITORED WITHIN 48 HOURS PRIOR TO EACH DOSE OF VISTIDE AND THE DOSE OF VISTIDE MODIFIED FOR CHANGES IN RENAL FUNCTION AS APPROPRIATE (SEE DOSAGE AND ADMINISTRATION). VISTIDE IS CONTRAINDICATED IN PATIENTS WHO ARE RECEIVING OTHER NEPHROTOXIC AGENTS.

NEUTROPENIA HAS BEEN OBSERVED IN ASSOCIATION WITH VISTIDE TREATMENT. THEREFORE, NEUTROPHIL COUNTS SHOULD BE MONITORED DURING VISTIDE THERAPY.

VISTIDE IS INDICATED ONLY FOR THE TREATMENT OF CMV RETINITIS IN PATIENTS WITH ACQUIRED IMMUNODEFICIENCY SYNDROME.

IN ANIMAL STUDIES CIDOFOVIR WAS CARCINOGENIC, TERATOGENIC AND CAUSED HYPOSPERMIA (SEE CARCINOGENESIS, MUTAGENESIS, & IMPAIRMENT OF FERTILITY).

 

VISTIDE SUMMARY

VISTIDE® (cidofovir injection)

VISTIDE® is the brand name for cidofovir injection.

VISTIDE is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). THE SAFETY AND EFFICACY OF VISTIDE HAVE NOT BEEN ESTABLISHED FOR TREATMENT OF OTHER CMV INFECTIONS (SUCH AS PNEUMONITIS OR GASTROENTERITIS), CONGENITAL OR NEONATAL CMV DISEASE, OR CMV DISEASE IN NON-HIV-INFECTED INDIVIDUALS.


See all Vistide indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Vistide (Cidofovir)

Topical treatment of CIN 2+ by cidofovir: results of a phase II, double-blind, prospective, placebo-controlled study. [2009.10]
OBJECTIVE: Randomized controlled trial evaluating a topical treatment for cervical intraepithelial neoplasia 2 and 3 (CIN 2+) using cidofovir... CONCLUSION: The medical topical treatment with cidofovir, at this point, cannot replace conisation, but it is a promising candidate for topical chemotherapy of CIN 2+ lesions; a larger prospective randomized study is needed to confirm our results.

Cidofovir efficacy in recurrent respiratory papillomatosis: a randomized, double-blind, placebo-controlled study. [2008.07]
OBJECTIVES: We performed a prospective, double-blind, placebo-controlled, longitudinal adjuvant therapy trial to determine the efficacy of cidofovir in the treatment of severe recurrent respiratory papillomatosis (RRP). Although results of case series suggest that cidofovir may decrease the frequency and rapidity of papilloma regrowth, no blinded placebo-controlled studies have demonstrated efficacy... CONCLUSIONS: A randomized, blinded, placebo-controlled trial is necessary in the study of RRP, because the natural history of the disease can include remissions and reactivations. We found a significant improvement in the Derkay Severity Score 12 months after the baseline assessment in patients treated with cidofovir. This effect, however, was also seen in the placebo group. Accordingly, we were unable to provide proof of efficacy of cidofovir in the treatment of RRP.

Novel treatment of atypical human papillomavirus-associated epithelial hyperplasia with cidofovir. [2011.09]
CONCLUSIONS: Cidofovir formulated as a gel can be safe and effective for the treatment of epithelial hyperplasia in those with human immunodeficiency virus infection. Published by Elsevier Inc.

Intravenous cidofovir for resistant cutaneous warts in a patient with psoriasis treated with monoclonal antibodies. [2011.08]
Human papilloma virus is a common and often distressing cutaneous disease...

Inhaled cidofovir as an adjuvant therapy for recurrent respiratory papillomatosis. [2011.04]
A previously healthy, full-term, 4-month-old boy presented with progressively weakening cry, hoarseness, and increased work of breathing. Flexible fiberoptic laryngoscopy revealed glottic papillomas, which were endoscopically removed with a microdebrider in the operating room (Derkay score 23)...

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Clinical Trials Related to Vistide (Cidofovir)

Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis [Recruiting]
The goal of this clinical research study is to learn if adding cidofovir to the standard of care can improve symptoms of hemorrhagic cystitis caused by the BK virus as compared to standard of care alone. The safety of cidofovir will also be studied.

Cidofovir Instillation in Hematopoietic Stem Cell Transplant (HSCT) Recipients With Hemorrhagic Cystitis [Not yet recruiting]

Cidofovir in Renal Transplant Recipients With BKVN [Recruiting]
This study will look at the safety, tolerability and effectiveness of cidofovir in kidney transplant patients who have been diagnosed with BK virus nephropathy (BKVN), a viral condition that can cause patients to reject transplanted kidneys. Up to 48 adult (age 18 years and older) kidney or pancreas transplant recipients with newly diagnosed BKVN will receive 1 of 3 cidofovir dose levels or placebo (non medicated substance) to identify the maximum tolerated dose. Dosing will be administered intravenously (by a tube running into a blood vessel). In addition to the screening visit, volunteers will participate for about 156 days which includes the screening period and 4 month follow-up phone call. Blood samples, urine samples, eye exams and physical exams are included in study procedures.

Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus [Recruiting]
RATIONALE: High-grade squamous intraepithelial lesions of the skin near the anus are caused by the human papillomavirus (HPV). Antiviral drugs,, such as cidofovir, act against viruses and may stop these lesions from becoming cancer.

PURPOSE: This phase II trial is studying the side effects and how well topical cidofovir works in treating HIV-infected patients with high-grade squamous intraepithelial lesions of the skin near the anus.

Trial of Topical Cidofovir for the Prevention of Hair Growth [Recruiting]
This is a single arm, single center placebo-controlled double-blind proof of concept study which will evaluate the safety and efficacy of topical cidofovir (both 1% and 3%)compared to placebo for the prevention of hair growth.

more trials >>

Reports of Suspected Vistide (Cidofovir) Side Effects

Myelodysplastic Syndrome (4)Therapeutic Response Decreased (4)Drug Ineffective FOR Unapproved Indication (3)Locked-in Syndrome (2)Blindness Cortical (2)Progressive Multifocal Leukoencephalopathy (2)Glioma (1)Cardiac Disorder (1)Pericardial Effusion (1)Ill-Defined Disorder (1)more >>


Page last updated: 2011-12-09

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