An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access

NCT00002135 | Completed

• 2 other identifiers: 037CGANS2224
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To provide oral ganciclovir to patients who require maintenance for control of cytomegalovirus (CMV) retinitis, but who lack patent permanent central venous access for long-term administration of intravenous drugs.

Conditions

Cytomegalovirus Retinitis; HIV Infections

Keywords

Retinitis; Ganciclovir; Administration, Oral; Acquired Immunodeficiency Syndrome

Interventions

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:

• Patients must have:
• AIDS.
• Stable CMV retinitis.
• Treatment with IV ganciclovir or IV foscarnet for at least 18 of the past 21 days.
• No permanent central IV catheter at present.
• Had a permanent central IV catheter removed two or more times within the past 6 months due to catheter infection or thrombosis.
• Consent of guardian if less than legal age of consent.

You may not qualify if:

• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• Require continuation of concomitant medications precluded by this protocol.
• Concurrent Medication:
• Excluded:
• Intravitreal anti-CMV treatment.
• Any other concomitant medications precluded by the protocol.
• Patients with the following prior condition are excluded:
• History of hypersensitivity to acyclovir or ganciclovir.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Roche Global Development - Palo Alto

Palo Alto, California, 94303, United States

Location

Related Publications (2)

• Intravenous versus oral ganciclovir: European/Australian comparative study of efficacy and safety in the prevention of cytomegalovirus retinitis recurrence in patients with AIDS. The Oral Ganciclovir European and Australian Cooperative Study Group. AIDS. 1995 May;9(5):471-7.

  PMID: 7639972 BACKGROUND

• Drew WL, Ives D, Lalezari JP, Crumpacker C, Follansbee SE, Spector SA, Benson CA, Friedberg DN, Hubbard L, Stempien MJ, et al. Oral ganciclovir as maintenance treatment for cytomegalovirus retinitis in patients with AIDS. Syntex Cooperative Oral Ganciclovir Study Group. N Engl J Med. 1995 Sep 7;333(10):615-20. doi: 10.1056/NEJM199509073331002.

  PMID: 7637721 BACKGROUND

MeSH Terms

Conditions

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

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Cytomegalovirus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Eye Diseases; Retinal Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; 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; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 1995-11

Locations

US (1)