Clinical trial NCT00002025: Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
Official title: Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Infections
Cytomegalovirus Retinitis
HIV Infections
Keywords: Retinitis
AIDS-Related Opportunistic Infections
Immune Tolerance
Injections, Intravenous
Ganciclovir
Cytomegalovirus Infections
Acquired Immunodeficiency Syndrome
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To make intravenous (IV) ganciclovir available to immunocompromised patients with life-threatening or sight-threatening Cytomegalovirus (CMV) infection, where the symptoms of the disease are too severe to allow admission to a controlled clinical study of ganciclovir therapy. To determine the safety and tolerance of 2 - 3 weeks induction course of ganciclovir IV followed by a maintenance course of ganciclovir IV for an indefinite duration. To tabulate the patient's clinical response.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Cytomegalovirus (CMV) disease who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS.
* Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening.
* Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible.
* Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency.
* Hypersensitivity to acyclovir or ganciclovir.
* Receiving antimetabolite treatment that cannot be discontinued.

Concurrent Medication:

Excluded:

* Antimetabolites.
* Alkylating agents.
* Nucleoside analogs (topical ophthalmics are permitted).
* Interferon.
* Foscarnet.
* Cytokines.

Patients with the following are excluded:

* Cytomegalovirus (CMV) infection who meet the criteria for a treatment IND protocol, or other clinical studies, including controlled clinical studies of anticytomegalovirus therapy in peripheral CMV retinitis in patients with AIDS.
* Mild to moderate CMV infections who fail to meet the severity criteria. CMV syndrome (i.e., cytopenia, increased liver enzymes, fever, viremia, viruria) is not considered immediately life-threatening.
* Transplant patients in whom trial reduction of immunosuppressive drug treatment is feasible.
* Children with congenital or neonatal CMV where there is not a documented primary or acquired immunodeficiency.
* Hypersensitivity to acyclovir or ganciclovir.
* Receiving antimetabolite treatment that cannot be discontinued.

Patients must qualify as follows:

* Previously enrolled in compassionate use study (ICM 1257/1257A) or have terminated from another Syntex ganciclovir study.
* Diagnosis of AIDS and life-threatening Cytomegalovirus (CMV) infection.
* Diagnosis of other immunodeficiencies other than AIDS, with life-threatening or sight-threatening CMV disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Roche Global Development - Palo Alto
state: California
Study officials:
References: