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| Sponsored by: |
Hoffmann-La Roche |
|---|---|
| Information provided by: | NIH AIDS Clinical Trials Information Service |
| ClinicalTrials.gov Identifier: | NCT00002273 |
Purpose
To attempt to demonstrate the efficacy of ganciclovir (DHPG) treatment of cytomegalovirus (CMV) colitis in AIDS patients by evaluating both clinical and virologic parameters. To determine acceptability and the safety profile of a 2-week course of intravenous (IV) DHPG therapy.
| Condition | Intervention |
|---|---|
|
Colitis HIV Infections |
Drug: Ganciclovir |
| Study Type: | Interventional |
| Study Design: | Treatment, Double-Blind |
| Official Title: | Double-Blind, Placebo-Controlled Study of Intravenous Ganciclovir (DHPG) for Cytomegalovirus Colitis in Patients With Acquired Immune Deficiency Syndrome |
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded within 2 days of study entry:
Contacts and Locations
More Information
| Study ID Numbers: | 029C, ICM 1288 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00002273 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
AIDS-Related Opportunistic Infections Ganciclovir Cytomegalovirus Infections Colitis Acquired Immunodeficiency Syndrome |
|
Opportunistic Infections Sexually Transmitted Diseases, Viral Gastrointestinal Diseases Colonic Diseases Acquired Immunodeficiency Syndrome Ganciclovir Intestinal Diseases Antiviral Agents Cytomegalovirus Immunologic Deficiency Syndromes Herpesviridae Infections |
Virus Diseases Digestive System Diseases HIV Infections AIDS-Related Opportunistic Infections Sexually Transmitted Diseases Cytomegalic Inclusion Disease Cytomegalovirus Infections DNA Virus Infections Gastroenteritis Colitis Retroviridae Infections |
|
Anti-Infective Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Gastrointestinal Diseases Colonic Diseases Infection Therapeutic Uses Cytomegalovirus Infections Retroviridae Infections RNA Virus Infections Immune System Diseases Acquired Immunodeficiency Syndrome Ganciclovir |
Intestinal Diseases Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases Digestive System Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections DNA Virus Infections Gastroenteritis Colitis |