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Sponsored by: |
Hoffmann-La Roche |
---|---|
Information provided by: | NIH AIDS Clinical Trials Information Service |
ClinicalTrials.gov Identifier: | NCT00017784 |
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.
Condition | Intervention | Phase |
---|---|---|
Cytomegalovirus Retinitis HIV Infections |
Drug: Valganciclovir |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | Open-Label Safety Study of Valganciclovir in Patients With CMV Retinitis and AIDS Who Have Complications Due to IV Treatment |
Estimated Enrollment: | 500 |
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients will not be eligible for this study if they:
United States, California | |
Santa Clara Valley Med Ctr | |
San Jose, California, United States, 95128 | |
Retina - Vitreous Associates Med Group | |
Beverly Hills, California, United States, 90211 | |
Wilbert Jordan | |
Paramount, California, United States, 90723 | |
Quest Clinical Research | |
San Francisco, California, United States, 94115 | |
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 | |
Puerto Rico | |
Fundacion Gastroenterologia de Diego | |
San Juan, Puerto Rico, 00909 |
Study ID Numbers: | 268C, ML16356 |
Study First Received: | June 11, 2001 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00017784 |
Health Authority: | United States: Food and Drug Administration |
AIDS-Related Opportunistic Infections Infusions, Intravenous Antiviral Agents Cytomegalovirus Retinitis valganciclovir |
Opportunistic Infections Sexually Transmitted Diseases, Viral Valganciclovir Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Ganciclovir Cytomegalovirus Immunologic Deficiency Syndromes |
Herpesviridae Infections Cytomegalovirus retinitis Virus Diseases HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Cytomegalic inclusion disease Retroviridae Infections Retinal Diseases |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Eye Infections, Viral Immune System Diseases |
Therapeutic Uses Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |