Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections
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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.
Condition | Intervention |
---|---|
Cytomegalovirus Infections HIV Infections |
Drug: Ganciclovir |
Study Type: | Interventional |
Study Design: | Primary Purpose: Treatment |
Official Title: | Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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.
Publications:
ClinicalTrials.gov Identifier: | NCT00002024 History of Changes |
Other Study ID Numbers: | 029B, ICM 1257A |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
AIDS-Related Opportunistic Infections Immune Tolerance Ganciclovir |
Drugs, Investigational Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Herpesviridae Infections DNA Virus Infections Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 10, 2013