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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Hoffmann-La Roche |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000768 |
To determine the oral bioavailability of three dose levels of oral ganciclovir given with and without glutamic acid hydrochloride in patients with cytomegalovirus (CMV) GI disease, and to compare the bioavailability of these regimens to that of standard intravenous (IV) ganciclovir.
Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment. Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration, but an optimum dose has not been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug.
Condition | Intervention | Phase |
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Colitis HIV Infections |
Drug: Glutamic acid hydrochloride Drug: Ganciclovir |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Pharmacokinetics Study |
Official Title: | A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients |
Estimated Enrollment: | 24 |
Long-term ganciclovir maintenance therapy has been recommended for CMV colitis or esophagitis following induction treatment. Oral ganciclovir is a likely candidate for maintenance because of its possible therapeutic value and ease of administration, but an optimum dose has not been determined. Since oral ganciclovir has a low bioavailability and is more soluble in an acid pH environment, the addition of glutamic acid hydrochloride may enhance gastrointestinal absorption of this drug.
All patients receive an induction regimen of IV ganciclovir administered twice daily for 21 to 42 (Per Amendment 3/4/95) days. A permanent venous catheter is implanted for the induction therapy. If clinically improved following induction, patients are then randomized to receive one of three doses of oral ganciclovir, given first without and then with oral glutamic acid hydrochloride, every 8 hours until they reach a steady state. PER AMENDMENT 3/14/95: After subjects have reached steady state with oral ganciclovir and glutamic acid hydrochloride then PK samples will be taken. Subjects will continue the dosing regimen they were assigned to (glutamic acid hydrochloride will be added if it resulted in at least 33% increased bioavailability) for up to 12 months or until relapse of CMV GI disease is documented. Subjects will be followed at monthly intervals for safety evaluation and for evidence of CMV GI relapse. Subjects who have clinical symptoms of relapse will undergo repeat endoscopy or colonoscopy to document the relapse.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Recommended:
Allowed:
Patients must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
PER AMENDMENT 3/14/95:
Concurrent Medication:
Excluded:
Prior Medication:
Excluded within 14 days prior to study entry:
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, California | |
San Francisco Gen Hosp | |
San Francisco, California, United States, 941102859 | |
United States, District of Columbia | |
Georgetown Univ Med Ctr | |
Washington, District of Columbia, United States, 20007 | |
United States, New York | |
Bellevue Hosp / New York Univ Med Ctr | |
New York, New York, United States, 10016 | |
Mount Sinai Med Ctr | |
New York, New York, United States, 10029 | |
United States, Ohio | |
Univ of Cincinnati | |
Cincinnati, Ohio, United States, 452670405 | |
United States, South Carolina | |
Julio Arroyo | |
West Columbia, South Carolina, United States, 29169 |
Study Chair: | Jacobson M | |
Study Chair: | Dieterich D | |
Study Chair: | Kotler D | |
Study Chair: | Laine L | |
Study Chair: | Kumar P |
Study ID Numbers: | ACTG 183 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000768 |
Health Authority: | United States: Federal Government |
Intestinal Absorption Ganciclovir Drug Therapy, Combination Cytomegalovirus Infections Colitis |
Administration, Oral Acquired Immunodeficiency Syndrome Biological Availability Glutamic Acid |
Sexually Transmitted Diseases, Viral Gastrointestinal Diseases Acquired Immunodeficiency Syndrome Colonic Diseases Ganciclovir Intestinal Diseases Cytomegalovirus Immunologic Deficiency Syndromes Herpesviridae Infections Virus Diseases |
Digestive System Diseases HIV Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Gastroenteritis Cytomegalic inclusion disease Colitis Retroviridae Infections |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Immune System Diseases Therapeutic Uses |
Lentivirus Infections Infection Antiviral Agents Pharmacologic Actions |