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| Sponsor: | 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 |
|
Anti-Infective Agents Communicable Diseases RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Gastrointestinal Diseases Colonic Diseases Acquired Immunodeficiency Syndrome Ganciclovir Intestinal Diseases Infection |
Antiviral Agents Pharmacologic Actions Immunologic Deficiency Syndromes Virus Diseases Digestive System Diseases HIV Infections Therapeutic Uses Sexually Transmitted Diseases Lentivirus Infections Gastroenteritis Colitis Retroviridae Infections |