CLINICAL TRIALS PROFILE FOR VALGANCICLOVIR HYDROCHLORIDE
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All Clinical Trials for VALGANCICLOVIR HYDROCHLORIDE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00002222 ↗ | A Study of Valganciclovir in the Treatment of Cytomegalovirus (CMV) Retinitis in Patients With AIDS | Completed | Hoffmann-La Roche | N/A | 1969-12-31 | The purpose of this study is to see if valganciclovir is a safe treatment for CMV retinitis in patients who have been treated for this condition in the past. This study also examines the effectiveness of valganciclovir in preventing the recurrence of CMV retinitis. |
| NCT00002377 ↗ | A Comparison of Valganciclovir and Ganciclovir in the Treatment of Cytomegalovirus (CMV) of the Eyes | Completed | Hoffmann-La Roche | Phase 3 | 1997-01-01 | To investigate the efficacy and safety of RS-79070 when used as induction therapy in patients with newly diagnosed peripheral retinitis. To assess the effects of induction and maintenance level dosing of RS-79070 on CMV viral load, estimated by plasma CMV PCR. To assess the pharmacokinetics of ganciclovir following administration of RS-79070 in the target population. |
| NCT00006145 ↗ | Preventing Cytomegalovirus (CMV) Organ Damage With Valganciclovir in People With HIV | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 3 | 2000-08-01 | Cytomegalovirus (CMV) infection is a common opportunistic infection (OI) in HIV patients. The purpose of this study is to find out whether valganciclovir, an antiviral approved by the FDA for the treatment of CMV in the eye, is safe and effective in preventing CMV organ damage in people with HIV. |
| NCT00016068 ↗ | Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation | Completed | National Cancer Institute (NCI) | Phase 3 | 2001-01-01 | RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing cytomegalovirus. PURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works in preventing cytomegalovirus in patients who have undergone donor stem cell transplantation. |
| NCT00016068 ↗ | Valganciclovir to Prevent Cytomegalovirus Infection in Patients Following Donor Stem Cell Transplantation | Completed | Fred Hutchinson Cancer Research Center | Phase 3 | 2001-01-01 | RATIONALE: Antivirals such as valganciclovir act against viruses and may be effective in preventing cytomegalovirus. It is not yet known if valganciclovir is effective in preventing cytomegalovirus. PURPOSE: This randomized phase III trial is studying valganciclovir to see how well it works in preventing cytomegalovirus in patients who have undergone donor stem cell transplantation. |
| NCT00017784 ↗ | Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection | Unknown status | Hoffmann-La Roche | Phase 3 | 1969-12-31 | 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. |
| NCT00031434 ↗ | Valganciclovir in Congenital CMV Infants | Completed | National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1/Phase 2 | 2002-07-01 | The purpose of this study is to evaluate how ganciclovir is metabolized when administered intravenously (by a needle inserted into a vein) following valganciclovir syrup, given by mouth to newborns and young infants with symptoms of congenital (present at birth) cytomegalovirus (CMV) disease. The study also seeks to identify a dose of valganciclovir that provides a comparable blood concentration to ganciclovir present in the blood of newborns with symptomatic congenital CMV disease. All study participants will receive 6 weeks of antiviral therapy (defined as ganciclovir and/or valganciclovir). Infants from 0 to 30 days old will participate in the study for 2 years. |
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