A Randomized Comparative Pharmacokinetic Study of Oral Ganciclovir After Treatment With Intravenous Ganciclovir for Cytomegalovirus Gastrointestinal Disease in AIDS Patients

NCT00000768 | Completed Phase 1

• 2 other identifiers: ACTG 18311158
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Colitis; HIV Infections

Keywords

Intestinal Absorption; Ganciclovir; Drug Therapy, Combination; Cytomegalovirus Infections; Colitis; Administration, Oral; Acquired Immunodeficiency Syndrome; Biological Availability; Glutamic Acid

Interventions

Glutamic acid hydrochloride DRUG

Ganciclovir DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Concurrent Medication:
• Recommended:
• PCP prophylaxis.
• Allowed:
• Antiretroviral therapy during induction and pharmacokinetic part of study, provided patient remains on the same antiretroviral therapy for the duration of the study.
• Chemotherapy for Kaposi's sarcoma, provided patient is hematologically stable for at least 30 days prior to study entry.
• Recombinant human erythropoietin.
• GM-CSF and G-CSF.
• Other medications necessary for patient's welfare, at the physician's discretion.
• Patients must have:
• HIV infection.
• Biopsy-proven cytomegalovirus (CMV) colitis.
• Life expectancy of at least 3 months.
• No active AIDS-defining opportunistic infection requiring therapy that is known to cause nephrotoxicity or myelosuppression.
• NOTE:

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Other etiologies for diarrhea identified at study entry.
• PER AMENDMENT 3/14/95:
• For subjects who have diarrhea - no other etiologies for diarrhea identified within 6 weeks of enrollment.
• Known hypersensitivity to study drugs.
• CMV retinitis.
• Concurrent Medication:
• Excluded:
• Acyclovir or probenecid (PER AMENDMENT 3/14/95).
• Immunomodulators.
• Biologic response modifiers (other than GM-CSF or G-CSF).
• Investigational agents, with the exception of treatment IND drugs.
• Antacids.
• H2 blockers.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Hoffmann-La Roche: collaborator

Study Sites (5)

Alabama Therapeutics CRS

Birmingham, Alabama, 35294, United States

Location

Ucsf Aids Crs

San Francisco, California, United States

Location

Washington U CRS

St Louis, Missouri, United States

Location

NY Univ. HIV/AIDS CRS

New York, New York, 10016, United States

Location

Univ. of Cincinnati CRS

Cincinnati, Ohio, 45267, United States

Location

Related Publications (1)

• Dieterich DT, Kotler DP, Busch DF, Crumpacker C, Du Mond C, Dearmand B, Buhles W. Ganciclovir treatment of cytomegalovirus colitis in AIDS: a randomized, double-blind, placebo-controlled multicenter study. J Infect Dis. 1993 Feb;167(2):278-82. doi: 10.1093/infdis/167.2.278.

  PMID: 8380610 BACKGROUND

MeSH Terms

Conditions

Colitis; HIV Infections; Multiple Acyl Coenzyme A Dehydrogenase Deficiency; Cytomegalovirus Infections; Acquired Immunodeficiency Syndrome

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Mitochondrial Diseases; Herpesviridae Infections; DNA Virus Infections; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jacobson M

  STUDY CHAIR

• Dieterich D

  STUDY CHAIR

• Kotler D

  STUDY CHAIR

• Laine L

  STUDY CHAIR

• Kumar P

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: August 1, 1998
• Last Updated: November 4, 2021

Record last verified: 2021-10

Locations

US (5)