Clinical trial NCT00002024: Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
Official title: Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Infections
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Immune Tolerance
Ganciclovir
Drugs, Investigational
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): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Roche Global Development - Palo Alto
state: California
Study officials:
References:
citation: 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. doi: 10.1056/NEJM199606063342302.