Valganciclovir in Patients With CMV Retinitis and AIDS Who Cannot Take Drugs by Injection
Verified June 2001
Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
First received: June 11, 2001
Last updated: June 23, 2005
Last Verified: June 2001
History of Changes
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.
Drug : Valganciclovir
Primary Purpose: Treatment
|Official Title:||Open-Label Safety Study of Valganciclovir in Patients With CMV Retinitis and AIDS Who Have Complications Due to IV Treatment|
Further study details as provided by NIH AIDS Clinical Trials Information Service:
CMV causes sight- or life-threatening opportunistic infections in people with AIDS.
Intravenous agents including ganciclovir, foscarnet, and cidofovir are presently approved as
treatments for CMV retinitis within this population. Ganciclovir and foscarnet induction and
maintenance therapy require daily infusions and usually require the use of long-term
indwelling central venous catheters. Although the treatment interval of cidofovir is longer,
administration necessitates the use of pre-hydration and probenecid in order to avoid a risk
of renal toxicity. Oral ganciclovir is an alternative to the intravenous formulation for the
maintenance treatment of CMV retinitis. However, because blood levels achieved after oral
ganciclovir are low compared to intravenous, oral ganciclovir cannot be used for induction
therapy. In an attempt to improve the bioavailability of ganciclovir, valganciclovir was
developed. Valganciclovir is a ganciclovir prodrug which, when administered orally, is
rapidly converted to the active compound ganciclovir during a first-pass process, with the
majority of hydrolysis occurring pre-systemically. Studies have shown that valganciclovir
tablets allow systemic exposure of ganciclovir comparable to that achieved with recommended
doses of intravenous ganciclovir.
Patients undergo an ophthalmologic exam by an ophthalmologist and safety and other laboratory tests to establish eligibility. No specific visits are requested by the drug usage plan following enrollment; however, patients should be seen for safety and/or clinical assessments and medication dispensation at periodic visits, consistent with standard of care. An ophthalmologic exam should be performed again at Week 3 (no later than Week 4), at the end of the induction treatment phase consistent with standard of care in order to ensure adequate response to therapy. Valganciclovir is provided on a monthly basis and only as long as the patient is assessed and information provided in a timely manner. This supply will be terminated 1 month subsequent to when the drug is available by prescription, unless otherwise decided.
|Ages Eligible for Study:||18 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Patients may be eligible for this study if they:
- Are 18 years of age or older.
- Are HIV-positive.
- Have active CMV retinitis, shown by an eye exam by an eye doctor, that needs treatment.
- Have had problems when drugs were given by injection, such as difficulty in finding a vein or problems (blood clots, vein inflammation, or infection) caused by injection devices.
- Agree to use effective methods of birth control (i.e., barrier methods) during the study and for 90 days after taking the study drug. Females who can have children must have a negative pregnancy test before entering the study.
- Stop breast-feeding before starting the study drug.
- Are pregnant or breast-feeding.
- Have developed CMV retinitis after a transplant.
- Have kidney disease and need hemodialysis.
- Are taking part in another drug study, unless approved by the study doctor.
- Take experimental drugs, or have taken them within 30 days before study entry, unless approved by the study doctor.
- Take drugs not allowed on the study, including foscarnet, cidofovir, and probenecid.
- Are not able to follow study procedures, including visits to the eye doctor and the
Patients will not be eligible for this study if they:
Contacts and LocationsChoosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017784
Locations Show More
|United States, California|
|Retina - Vitreous Associates Med Group|
|Beverly Hills, California, United States, 90211|
|Paramount, California, United States, 90723|
|Quest Clinical Research|
|San Francisco, California, United States, 94115|
|Santa Clara Valley Med Ctr|
|San Jose, California, United States, 95128|
|United States, Florida|
|IDC Research Initiative|
|Altamonte Springs, Florida, United States, 32701|
|United States, Georgia|
|Ingenix Kern McNeill Decatur|
|Atlanta, Georgia, United States, 30309|
|United States, Tennessee|
|Nashville Health Management Foundation / Vanderbilt Univ|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|North Texas Infectious Disease Consultants|
|Dallas, Texas, United States, 75246|
|Fundacion Gastroenterologia de Diego|
|San Juan, Puerto Rico, 00909|
Sponsors and CollaboratorsHoffmann-La Roche
|Responsible Party:||Hoffmann-La Roche|
|ClinicalTrials.gov Identifier:||NCT00017784 History of Changes|
|Other Study ID Numbers:||268C|
|Study First Received:||June 11, 2001|
|Last Updated:||June 23, 2005|
Keywords provided by NIH AIDS Clinical Trials Information Service:AIDS-Related Opportunistic Infections
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on March 20, 2018
This information is provided by ClinicalTrials.gov.