HIV Infections Clinical Trial
Official title:
Open-Label Safety Study of Valganciclovir in Patients With CMV Retinitis and AIDS Who Have Complications Due to IV Treatment
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.
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.
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Endpoint Classification: Safety Study, Primary Purpose: Treatment
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