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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002024
• Other study ID #: 029B
• Secondary ID: ICM 1257A
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: September 1989
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Cytomegalovirus Infections
• HIV Infections
• Infection

Intervention

Drug:
• Ganciclovir

Locations

Country	Name	City	State
United States	Roche Global Development - Palo Alto	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

References & Publications (1)

Spector SA, McKinley GF, Lalezari JP, Samo T, Andruczk R, Follansbee S, Sparti PD, Havlir DV, Simpson G, Buhles W, Wong R, Stempien M. Oral ganciclovir for the prevention of cytomegalovirus disease in persons with AIDS. Roche Cooperative Oral Ganciclovir Study Group. N Engl J Med. 1996 Jun 6;334(23):1491-7. — View Citation