View clinical trials related to Cytomegalovirus Retinitis.
Filter by:Clinical study of high concentration ganciclovir eye drops in the treatment of cytomegalovirus retinitis
Ophthalmological screening for cytomegalovirus retinitis (CMVR) for HIV/AIDS patients is important. However, the manual screening with fundus imaging is laborious and subjective. Deep learning (DL) system has been developed for the automated detection of various eye diseases with high accuracy and efficiency, including diabetic retinopathy, glaucoma, age-related macular degeneration (AMD), papilledema, lattice degeneration and retinal breaks, from ocular fundus photographs. UWF imaging is a relatively new imaging modality for DL system but has also shown extraordinary talents in automatic retinal analysis With the press for routine CMVR screening in AIDS patients and the great capacity of DL system, the use of deep learning (DL) system to AIDS-related CMVR with Ultra-Widefield (UWF) fundus images is promising. The investigators previously developed a DL system to detect AIDS-related CMVR. For further evaluating the applicability of the DL system, a prospective dataset is needed.
This prospective, non-randomized, non-controlled clinical trial was conducted to examine the clinical outcomes achieved by using initial high-dose intravitreal ganciclovir injections of ganciclovir in treating cytomegalovirus (CMV) retinitis in patients without human immunodeficiency virus (HIV) infection.
Cidofovir is an acyclic nucleotide analog with broad-spectrum antiviral activity against herpesviruses. Its potency in inhibiting HCMV has been shown in conventional in vitro studies. It is approved for the systemic treatment of human cytomegalovirus (HCMV) retinitis in patients with AIDS and as a second line therapy for HCMV infections not responding to ganciclovir or foscarnet. In intensive care patients continuous venovenous haemofiltration (CVVH) is a well-established extracorporal renal replacement therapy with a high clearance rate. Pharmacokinetic studies of antifungal agents in critically ill patients treated with CVVH are rare. Elimination of any given drug by renal replacement therapy is determined by several major factors which are membrane specific, due to physico-chemical properties of the drug and characteristics of the renal replacement technique used. Study objective The trial is conducted to investigate the pharmacokinetics of cidofovir during CVVH in critically ill patients. It is suspected that Hemofiltration will influence cidofovir plasma levels.
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).
Some patients with HIV/AIDS suffer from a dangerous viral infection of the retina (and other organs) called cytomegalovirus infection (CMV). The medications currently used to treat CMV all have serious side effects. AIDS patients are prone to this infection because their immune system produces a lower number of CD4+T lymphocytes, the type of blood cells that fight viral infections. Some new HIV medications strengthen the immune system. This study will investigate the possibility that CMV patients on these HIV medications can develop immune systems strong enough to fight CMV without CMV medication. The study will enroll a maximum of 15 adult HIV/AIDS patients who have a CD4+T cell count over 150 cells/microliter and who have inactive CMV retinitis that is not immediately sight threatening. It is expected to last approximately 2 years. Each prospective participant will have a physical examination and complete eye examination, including retina photographs, with the eye examination and retina photographs repeated 2 weeks later. If there is no evidence of active CMV retinitis, the participant will be enrolled in the study, and CMV medication will be stopped. The participant will have physical and eye examinations every 2 weeks for the first 3 months of the study, and every 3 weeks for the next 3 months. After 6 months, the frequency of the examinations will be 2-8 weeks, depending on the participant's CD4 count. After one year, a participant with a CD4 count remaining over 150 cells/microliter may return to the care of a local ophthalmologist with HIV/CMV experience, revisiting the clinical center every 6 months. The participant's CMV medication will be restarted when CMV retinitis becomes active, which will terminate participation in the study.
The purpose of this study is to make valganciclovir available, before it is approved for marketing, to HIV-infected patients who have cytomegalovirus (CMV) retinitis (eye infection) and cannot take drugs by injection. This study also will look at the safety of using valganciclovir as starting and/or ongoing therapy. CMV can cause serious AIDS-related infections in patients with HIV. Drugs that are effective against CMV eye infections can be given only by injection; this calls for a thin tube to be placed into a vein in the chest so that the patient is not put through getting too many needle sticks. An experimental drug, valganciclovir, is similar to 1 of these approved drugs, ganciclovir, but is more convenient and easier to use since it can be taken by mouth. Once in the body, valganciclovir changes to ganciclovir. Studies have shown that valganciclovir tablets can result in the same level of ganciclovir in the blood as ganciclovir injection.
The purpose of this study is to understand how changes in the immune system of HIV-infected patients affect their risk for 3 serious infections: Pneumocystis carinii pneumonia (PCP), cytomegalovirus (CMV) retinitis, or CMV organ disease. The purpose also is to understand how anti-HIV medicines may improve the immune system in these patients. (This purpose reflects a change in the AIDS-related [opportunistic] infections studied.) Presently, HIV-infected patients who have had PCP or CMV disease stay on lifelong therapy to prevent the return of the disease. This study is trying to see if a special lab test can help identify which patients can stop this preventive therapy without having another episode of PCP or CMV organ disease. (This rationale reflects a change in the AIDS-related infections studied.)
OBJECTIVES: I. Evaluate the safety and efficacy of intravenous cidofovir in patients with small peripheral cytomegalovirus retinitis. II. Obtain safety and efficacy data related to different dosages of cidofovir.
To determine whether cidofovir (HPMPC) therapy administered by intravenous infusion can extend the time to progression of peripheral cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the safety and tolerance of HPMPC therapy when administered by intravenous infusion in AIDS patients with CMV retinitis that is not immediately sight-threatening. To evaluate the virologic effects of intravenous HPMPC therapy on CMV shedding in urine, blood, and/or semen. To evaluate the impact of HPMPC therapy on visual acuity.