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| Sponsor: | Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002024 |
Purpose
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: | Treatment, Dose Comparison |
| Official Title: | Ganciclovir: Compassionate Use in Patients With Serious or Life-Threatening Cytomegalovirus Infections |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
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.
Contacts and Locations
More Information
| Study ID Numbers: | 029B, ICM 1257A |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002024 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Immune Tolerance Ganciclovir |
Drugs, Investigational Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
|
Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Ganciclovir Infection Antiviral Agents Pharmacologic Actions |
Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Cytomegalovirus Infections DNA Virus Infections Retroviridae Infections |