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

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ganciclovir

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, Ganciclovir, Administration, Oral, Acquired Immunodeficiency Syndrome

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Roche Global Development - Palo Alto

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002135

First Posted

November 2, 1999

Last Updated

June 23, 2005

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT00002135

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 1995

Overall Recruitment Status

Completed

Study Start Date

undefined (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cytomegalovirus Retinitis, HIV Infections

Keywords

Retinitis, Ganciclovir, Administration, Oral, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Ganciclovir

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Facility Information:

Facility Name

Roche Global Development - Palo Alto

City

Palo Alto

State/Province

California

ZIP/Postal Code

94303

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

7639972

Citation

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.

Results Reference

background

PubMed Identifier

7637721

Citation

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.

Results Reference

background

Cytomegalovirus Retinitis, HIV Infections

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial