Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Hoffmann-La Roche


Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier
NCT00002135

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: November 1995
History of Changes
Purpose

Purpose

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.

Condition Intervention
Cytomegalovirus Retinitis
HIV Infections

Drug : Ganciclovir

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: An Open-Label Safety Study of Oral Ganciclovir Maintenance Treatment of CMV Retinitis in People With Limited Venous Access

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Detailed Description:

Patients receive oral ganciclovir as maintenance. Patients enrolled at time of closure of enrollment will receive 2 months of study drug and undergo follow-up.

Eligibility

Eligibility

Ages Eligible for Study: 13 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

Inclusion Criteria
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.

  • Exclusion Criteria
    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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002135

Locations

United States, California
Roche Global Development - Palo Alto
Palo Alto, California, United States, 94303

Sponsors and Collaborators

Hoffmann-La Roche
More Information

More Information


Responsible Party: Hoffmann-La Roche  
ClinicalTrials.gov Identifier: NCT00002135   History of Changes  
Other Study ID Numbers: 037C  
  GANS2224  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Retinitis
Ganciclovir
Administration, Oral
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
HIV Infections
Retinitis
Cytomegalovirus Retinitis
Ganciclovir
Ganciclovir triphosphate

ClinicalTrials.gov processed this data on December 08, 2017
This information is provided by ClinicalTrials.gov.