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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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.

Conditions

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Cytomegalovirus Retinitis HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Ganciclovir

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Roche Global Development - Palo Alto

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 7639972 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 7637721 (View on PubMed)

Other Identifiers

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GANS2224

Identifier Type: -

Identifier Source: secondary_id

037C