Valcyte

Cytomegalovirus Retinitis, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome + 4 more

Treatment

10 FDA approvals

20 Active Studies for Valcyte

What is Valcyte

Valganciclovir

The Generic name of this drug

Treatment Summary

Valganciclovir hydrochloride is a medication manufactured by Roche that is used to treat cytomegalovirus infections. It is an antiviral drug that is converted to ganciclovir after it is taken orally. This conversion happens in the intestines and liver.

Valcyte

is the brand name

image of different drug pills on a surface

Valcyte Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Valcyte

Valganciclovir

2001

31

Approved as Treatment by the FDA

Valganciclovir, also called Valcyte, is approved by the FDA for 10 uses like prophylaxis of Cytomegalovirus infection and Cytomegalovirus (CMV) Infection .

prophylaxis of Cytomegalovirus infection

Cytomegalovirus (CMV) Infection

Acquired Immune Deficiency Syndrome (AIDS)

Cytomegalovirus Retinitis

Cytomegalovirus Infections

Lung Transplant

Acquired Immunodeficiency Syndrome

Cytomegalovirus Infections

Cardiac Transplant

Kidney Transplant

Effectiveness

How Valcyte Affects Patients

Valganciclovir is an antiviral medication used to treat cytomegalovirus infections. It works by being converted into ganciclovir in the body, which then gets incorporated into the DNA of the virus and prevents it from replicating. This stops the virus from spreading and eventually causes it to die off.

How Valcyte works in the body

Valganciclovir is converted to ganciclovir in the body. Ganciclovir then binds to DNA in virus-infected cells, making it harder for the virus to replicate. This stops the virus from making copies of itself, and eventually it dies off. Ganciclovir works better on viruses than normal cells, so it can stop the virus without harming the body's cells.

When to interrupt dosage

The measure of Valcyte is contingent upon the determined illness, including Cardiac Transplant, Cytomegalovirus Infections and Cytomegalovirus Infections. Dosage can be found in the table below, corresponding to the procedure of application.

Condition

Dosage

Administration

Cytomegalovirus Infections

, 450.0 mg, 50.0 mg/mL

, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution - Oral, For solution

Acquired Immunodeficiency Syndrome

, 450.0 mg, 50.0 mg/mL

, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution - Oral, For solution

Kidney Transplant

, 450.0 mg, 50.0 mg/mL

, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution - Oral, For solution

Cytomegalovirus Infections

, 450.0 mg, 50.0 mg/mL

, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution - Oral, For solution

Lung Transplant

, 450.0 mg, 50.0 mg/mL

, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution - Oral, For solution

Cardiac Transplant

, 450.0 mg, 50.0 mg/mL

, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution - Oral, For solution

Cytomegalovirus Retinitis

, 450.0 mg, 50.0 mg/mL

, Tablet, film coated, Oral, Tablet, film coated - Oral, Tablet, Powder, for solution, Powder, for solution - Oral, Tablet - Oral, For solution - Oral, For solution

Warnings

There are 20 known major drug interactions with Valcyte.

Common Valcyte Drug Interactions

Drug Name

Risk Level

Description

Aclidinium

Minor

Valganciclovir may decrease the excretion rate of Aclidinium which could result in a higher serum level.

Acrivastine

Minor

Valganciclovir may decrease the excretion rate of Acrivastine which could result in a higher serum level.

Albutrepenonacog alfa

Minor

Valganciclovir may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.

Almasilate

Minor

Valganciclovir may decrease the excretion rate of Almasilate which could result in a higher serum level.

Alogliptin

Minor

Valganciclovir may decrease the excretion rate of Alogliptin which could result in a higher serum level.

Valcyte Toxicity & Overdose Risk

An overdose of valganciclovir could cause increased kidney damage.

image of a doctor in a lab doing drug, clinical research

Valcyte Novel Uses: Which Conditions Have a Clinical Trial Featuring Valcyte?

Currently, 68 active studies are assessing the potential of Valcyte to treat Cardiac Transplantation, Acquired Immunodeficiency Syndrome and Cytomegalovirus Infections.

Condition

Clinical Trials

Trial Phases

Cytomegalovirus Retinitis

0 Actively Recruiting

Cytomegalovirus Infections

3 Actively Recruiting

Phase 2

Kidney Transplant

34 Actively Recruiting

Phase 2, Phase 1, Phase 4, Not Applicable, Phase 3

Cytomegalovirus Infections

0 Actively Recruiting

Cardiac Transplant

10 Actively Recruiting

Not Applicable, Phase 2, Phase 3, Phase 4

Acquired Immunodeficiency Syndrome

5 Actively Recruiting

Phase 1, Phase 2, Not Applicable

Lung Transplant

17 Actively Recruiting

Not Applicable, Phase 2, Phase 3, Phase 1

Valcyte Reviews: What are patients saying about Valcyte?

5

Patient Review

4/4/2008

Valcyte for Cytomegalovirus Infection of the Retina in AIDS patients

I am a single lung transplant recipient and have been on this medication for a while. It is very costly, over $3300 per month, but it has been effective. I may have to stop taking it because I cannot afford it.

5

Patient Review

7/4/2009

Valcyte for Treatment to Prevent Cytomegalovirus Disease

I used this medication for about six weeks after my transplant, but then I started vomiting and developed a rash, so I had to stop.

5

Patient Review

5/21/2009

Valcyte for Prevention of CMV Infection Post Kidney Transplant

I had this treatment after an organ transplant. It was very effective in boosting my immune system.

5

Patient Review

6/19/2010

Valcyte for Treatment to Prevent Cytomegalovirus Disease

So far, this treatment has been effective. I'm hoping it will be a long-term solution.

4.7

Patient Review

12/27/2016

Valcyte for Treatment to Prevent Cytomegalovirus Disease

Valcyte has been great for me. I was worried about the fatigue, but it's manageable and the drug is really effective. No side effects whatsoever- would definitely recommend.

4.7

Patient Review

4/28/2009

Valcyte for Prevention of CMV Infection Post Kidney Transplant

I was diagnosed with CMV retinitus 10 years ago and have been HIV+ for 20 years. The virus has been controlled since then, but I am now blind in one eye. Valcyte has had few serious side effects so far, but the idea of having to take this medication for the rest of my life is depressing.

4.3

Patient Review

10/13/2009

Valcyte for Cytomegalovirus Infection of the Retina in AIDS patients

I've only been taking this medication for a little while, and I've already lost twenty-three pounds. I also had an esophageal ulcer, gastritis, heartburn, reflux, and an ulcer on my ankle before starting this treatment - none of which I have now.

4

Patient Review

7/8/2011

Valcyte for Cytomegalovirus Infection of the Retina in AIDS patients

I'm seeing results already and my vision is returning. Not sure how long the treatment will take, but so far so good!

4

Patient Review

6/26/2013

Valcyte for Prevention of CMV Infection Post Kidney Transplant

I can't afford this medication, but it's really effective.

3.3

Patient Review

10/19/2016

Valcyte for Prevention of CMV Infection After Heart Transplant

I've been prescribed this for a few months now and, all things considered, it's working well since my heart transplant. It is very costly, even with insurance coverage, because of copays and other expenses. I hope and pray that we can all find a way to afford this medication.

3

Patient Review

3/3/2011

Valcyte for Prevention of Cytomegalovirus Disease After Kidney-Pancreas Transplantation

I took this medication in high doses after a liver transplant and the development of CMV. This permanently affected the nerves in my legs and feet, causing intolerable pain. I considered suicide but my doctor ignored this. If you experience any nerve pain at all while taking this medication, please demand an alternate from your doctor!

2.7

Patient Review

6/8/2009

Valcyte for Prevention of CMV Infection Post Kidney Transplant

Even with insurance, this medication is quite expensive. Without coverage, it would be unaffordable for most people. I am lucky that my insurance covers such a large portion of the cost.

2.3

Patient Review

1/25/2008

Valcyte for Prevention of CMV Infection Post Kidney Transplant

image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about valcyte

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the side effects of Valcyte?

"nausea, or vomiting

The possible side effects of the medication are: diarrhea, upset stomach, dizziness, loss of balance or coordination, drowsiness, unsteadiness, shaking (tremors), diarrhea, nausea, or vomiting."

Answered by AI

What is Valcyte used for?

"VALCYTE is used to treat CMV retinitis in people with AIDS. CMV retinitis is an infection of the eyes caused by the CMV virus."

Answered by AI

Is Valcyte an immunosuppressant?

"Valcyte is not an immunosuppressant, though it is often prescribed to people taking immunosuppressants after a transplant to prevent a CMV infection."

Answered by AI

How long can you take Valcyte?

"The recommended dose of Valcyte is two tablets taken twice a day for 21 days. Taking this medication for more than 21 days may increase your risk of developing side effects."

Answered by AI

Clinical Trials for Valcyte

Image of New Jersey Community Research Initiative in Newark, United States.

AI-DBT for Suicide Prevention in HIV/AIDS

18+
All Sexes
Newark, NJ

One in four older persons living with HIV/AIDS (PLWHA) report at least one suicide attempt in their lifetime, and the risk for death by suicide is 100 times higher in PLWHA than in the general population. Currently, there are no behavioral interventions that specifically address suicide prevention for older PLWHA, despite their unique biopsychosocial and structural risk factors. Through this work, investigators will adapt Dialectical Behavior Therapy, an evidence-based intervention for suicide prevention, for patients with PLWHA to be delivered by an AI-powered conversational Agent developed by our industry partner, Empower Health. Investigators will then pilot test the feasibility, usability, acceptability and preliminary efficacy to improve self-efficacy to manage negative emotions in n=50 older adults living with HIV/AIDS.

Recruiting
Has No Placebo

New Jersey Community Research Initiative (+1 Sites)

Elissa Kozlov, PhD

Image of University of California, Los Angeles in Los Angeles, United States.

Testosterone Replacement for Kidney Failure

18+
Male
Los Angeles, CA

This prospective study aims to evaluate the safety and efficacy of testosterone replacement therapy (TRT) as an adjunct to an enhanced recover after surgery (ERAS) protocol in men with end-stage renal disease (ESRD) undergoing kidney transplantation. Participants will be highly-listed hypogonadal men, defined as total testosterone level \<300 on two occasions with clinical symptoms of hypogonadism, with ESRD who are expected to receive a kidney transplant within 6 months. Participants will be started on TRT, ideally for at least 3 months prior transplantation. The investigators will perform a subset analysis to evaluate if there is a significant difference in our endpoints by comparing these two subgroups (Three months or more receiving TRT vs. Less than three months receiving TRT). There will be no cut-off time for pre-transplant TRT. Following the intervention period, a historical control cohort of age-matched and health-matched patients will be identified, who have followed a standard transplant protocol that does not incorporate TRT. The primary outcome will evaluate safety, including 30- and 90-day adverse events, 3, 6, and 12-month allograft survival, and overall patient survival. Secondary outcomes will focus on (1) qualitative assessments of symptoms using validated questionnaires, (2) quantitative improvements in the hormonal profile before and after initiation of TRT and surgery, and (3) allograft function and incidence of delayed graft function. The results of this study could provide novel insights into the benefits of TRT in improving surgical outcomes in men with ESRD undergoing kidney transplantation.

Phase 1 & 2
Waitlist Available

University of California, Los Angeles

Image of New York University Langone Health in New York, United States.

GGTA1 KO Thymokidney for Kidney Failure

40 - 70
All Sexes
New York, NY

The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow-up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant or for 52 weeks following nephrectomy, if required.

Phase 1 & 2
Recruiting

New York University Langone Health

United Therapeutics

Image of Los Angeles General Medical Center in Los Angeles, United States.

Decision Support Tool for HIV Treatment

18+
All Sexes
Los Angeles, CA

This study is testing software designed to help healthcare providers choose the best HIV treatment combinations for their patients. HIV medicines, known as antiretroviral therapy (ART), can be complex to manage because the right regimen depends on many factors-such as drug resistance, other health conditions, and medication schedules. Many people with HIV are cared for by general clinicians who may not have access to HIV specialists, which can make treatment decisions more challenging. In this study, healthcare providers will use patient cases to compare standard HIV treatment resources with a new clinical decision support tool that gives evidence-based ART recommendations at the point of care. The investigators hypothesize that using the tool will help providers select treatment plans that better match clinical guidelines, make decisions faster, reduce mental effort, and increase overall satisfaction with the prescribing process.

Waitlist Available
Has No Placebo

Los Angeles General Medical Center

Hayoun Lee, PhD

Have you considered Valcyte clinical trials?

We made a collection of clinical trials featuring Valcyte, we think they might fit your search criteria.
Go to Trials
Image of University of California, San Francisco in San Francisco, United States.

Trimethoprim-Sulfamethoxazole for Urinary Tract Infections

13 - 29
All Sexes
San Francisco, CA

The goal of this clinical trial is to learn if a common antibiotic called trimethoprim-sulfamethoxazole (TMP-SMX) can help prevent urinary tract infections (UTIs) in children and young adults who recently had a kidney transplant. Most people take TMP-SMX for about 6 months after getting a kidney transplant. In this study, researchers want to see what happens if people keep taking it for 6 more months. The main questions this study is asking are: * Does TMP-SMX lower the number of UTIs in the first year after transplant? * What side effects or problems do participants have while taking TMP-SMX? Researchers will compare TMP-SMX to a placebo (a look-alike pill that does not contain any medication) to see if TMP-SMX works to prevent UTIs. Participants will: * Take either TMP-SMX or a placebo pill by mouth every day for 6 months * Have three visits to touch base with the study team about any issues * Complete short monthly online surveys about any symptoms or side effects * Share blood and urine test results from their regular transplant clinic visits

Phase 4
Waitlist Available

University of California, San Francisco

Alexandra Bicki, MD

Have you considered Valcyte clinical trials?

We made a collection of clinical trials featuring Valcyte, we think they might fit your search criteria.
Go to Trials
Image of Cedars Sinai Medical Center in Los Angeles, United States.

Berinert for Kidney Transplant Outcomes

18 - 75
All Sexes
Los Angeles, CA

The purpose of this study is to find out if Berinert can improve kidney function in the first year after transplant and to find out what effects, good or bad, Berinert will have in the kidney recipient. This research study will compare Berinert to placebo. The placebo looks exactly like Berinert but does not contain any active drug. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. Neither you or the study doctor can choose or know which group is assigned. The primary objective is to test whether intrarenal artery C1 esterase inhibitor (C1INH) injection into the donor kidney prior to transplantation improves kidney function in recipients of high risk, deceased donor kidney transplants as measured by 12-month Estimated Glomerular Filtration Rate (eGFR) Chronic Kidney Disease Epidemiology Collaboration (CDK-EPI)

Phase 2
Recruiting

Cedars Sinai Medical Center (+5 Sites)

Peter S Heeger, MD

Image of New York University Langone Health in New York, United States.

Xenokidney for Kidney Failure

40 - 70
All Sexes
New York, NY

The purpose of this study is to evaluate the safety and efficacy of the 10 GE Xenokidney in patients with ESRD who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2). The study consists of xenotransplantation followed by a 24-week Post-transplant Follow up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, 10 GE Xenokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant.

Phase 1 & 2
Recruiting

New York University Langone Health

United Therapeutics

Image of University of California, San Francisco in San Francisco, United States.

Maraviroc for Primary Graft Dysfunction

18+
All Sexes
San Francisco, CA

Lung transplant recipient survival lags other solid organ recipients, with the main early cause of death being primary graft dysfunction (PGD). PGD occurs in up to 1/3 of all recipients, is driven by the body's innate immune response, and has no known medical therapies for treatment or prevention. Investigators have recently shown that Natural Killer (NK) cells, a key innate immune cell, are critical in causing PGD. Importantly, the investigators found that Maraviroc, an FDA-approved drug that works to inhibit these immune cells, prevented lung injury in mouse models of PGD. The goal of this clinical trial is to learn if Maraviroc works to treat PGD in Lung Transplant patients who are above the age of 18 and have a PGD risk score greater than 50%. The objectives the study hopes to address are: To address the safety and tolerability of Maraviroc. To test a strategy for PGD enrichment in a lung transplant population. To measure the efficacy and biological efficacy of using Maraviroc. To study the biochemical, physiologic, and molecular effects of the drug on the body. This will be a double blind study where patients will either get the Maraviroc drug or a placebo. Researchers will then compare the two groups to address the above objectives. Participants will: Take drug Maraviroc or a placebo every 12 hours for 3 days post surgery. Follow up will occur during the entire length of stay at UCSF, about 16 days, with a single 12 month follow up once released.

Phase 2
Waitlist Available

University of California, San Francisco

Daniel Calabrese, MD

Have you considered Valcyte clinical trials?

We made a collection of clinical trials featuring Valcyte, we think they might fit your search criteria.
Go to Trials