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Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections



Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections

For Condition: Cytomegalovirus Infections,HIV Infections
Status: Completed
Sponsor(s): Hoffmann-La Roche ,
Synopsis: To provide ganciclovir on a compassionate use basis to immunocompromised patients with serious cytomegalovirus (CMV) infections and to study safety and efficacy in this patient population.
Details:
Eligibility:
Study Type:  Interventional, Treatment, Dose Comparison
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Concurrent Medication: Allowed: - Topical acyclovir. Exclusion Criteria Co-existing Condition: Patients with the following are excluded: - Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria. - Transplant where a trial reduction of immunosuppressive drug treatment is not feasible. - Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency. - Neutropenia unless it is pre-existing. - Thrombocytopenia unless it is pre-existing. Concurrent Medication: Excluded: - Other myelosuppressive drugs such as cancer chemotherapy agents, interferon, foscarnet, or nucleoside analogs. Patients with the following are excluded: - Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria. - Transplant where a trial reduction of immunosuppressive drug treatment is not feasible. - Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency. - Neutropenia unless it is pre-existing. - Thrombocytopenia unless it is pre-existing. Patients must be immunocompromised with a serious cytomegalovirus (CMV) infection. This would include pneumonia, gastrointestinal disease, hepatitis, or other organ-specific disease or severe wasting syndrome. Patients with pre-existing neutropenia or thrombocytopenia, and immediate life-threatening disease can be included if the investigator believes that delay in starting ganciclovir therapy is not advisable. In such patients, the investigator must advise the patient of the risk of further marrow suppression and the increased risk of infection or bleeding; and the patient must sign an amended informed consent form.
Total Enrollment: 

Location and Contact Information:

Roche Global Development - Palo Alto
Palo Alto,  California,  94303
United States
 


Additional Information:
Study ID Numbers:  029B;  ICM 1257A
Study Start Date: 
Record last reviewed: September 1989
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002024

Other Cytomegalovirus Infections Studies:
1. Using the Drug Thalidomide to Stimulate T Cells in HIV Positive Patients

2. Double-Blind Placebo-Controlled Study Comparing the Combination of 15% SP-303 Gel with Acyclovir Versus Acyclovir Alone for the Treatment of Recurrent Herpes Simplex Virus (HSV) Infections in Subjects with Acquired Immunodeficiency Syndrome (AIDS)

3. Growth Hormone Treatment of Children with HIV-Associated Growth Failure

4. Safety and Acceptability of PRO 2000 Vaginal Gel in HIV Uninfected Women in India

5. Effectiveness of AIDSVAX B/E Vaccine in Intravenous Drug Users in Bangkok, Thailand

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