A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes

NCT ID: NCT00001062

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1998-01-31

Brief Summary

To determine whether alternating oral ganciclovir with intravenous ( IV ) ganciclovir can prevent relapse of Cytomegalovirus ( CMV ) retinitis and improve quality of life in AIDS patients.

A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer, without the need for a permanent indwelling IV catheter. Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir, patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease, as opposed to the current therapeutic strategy in which changes in therapy are event-driven. Also, the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter.

Detailed Description

A systemic treatment strategy for CMV retinitis is needed that will be effective yet convenient to administer, without the need for a permanent indwelling IV catheter. Although oral ganciclovir has been used as maintenance following induction with IV ganciclovir, patients with reactivation of disease must be reinduced IV. A fixed-schedule regimen in which oral and IV ganciclovir are alternated may prevent reactivation and progression of disease, as opposed to the current therapeutic strategy in which changes in therapy are event-driven. Also, the duration of intermittent IV therapy required to control disease may be short enough to eliminate the need for an indwelling catheter.

Patients receive IV induction with ganciclovir for 2 weeks followed by an alternating course of 3 weeks of oral ganciclovir and 1 week of IV drug for four cycles (16 weeks). If CMV retinitis fails to arrest after initial induction, IV ganciclovir is administered for an additional 2 weeks.

Conditions

Cytomegalovirus Retinitis; HIV Infections

Keywords

Infusions, Intravenous; Ganciclovir; Administration, Oral; Acquired Immunodeficiency Syndrome; Antiviral Agents; Cytomegalovirus Retinitis

Study Design

• Primary Study Purpose: TREATMENT

Interventions

Ganciclovir

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Concurrent Medication:

Allowed:

• Erythropoietin, G-CSF, or GM-CSF.
• Antiretrovirals.

Patients must have:

• HIV infection.
• Evaluable CMV retinitis with photographable lesions.
• Life expectancy of at least 6 months.
• No active AIDS-defining opportunistic infections or malignancies that require nephrotoxic or myelosuppressive therapy.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

• Evidence of retinal vascular or related infectious disease or other retinal lesions that would interfere with the ability to detect responses to therapy or progression.
• Corneal, lens, or vitreous opacification precluding funduscopic exam.
• Clinically significant pulmonary or neurologic impairment other than seizure disorder or CNS mass lesion.
• Inability to obtain temporary IV access.
• Requirement for permanent catheters for IV ganciclovir administration.
• Uncontrolled diarrhea or nausea preventing ingestion of medicine.
• Known hypersensitivity to IV or oral ganciclovir.

Concurrent Medication:

Excluded:

• Immunomodulators.
• Biologic response modifiers.
• Interferon.
• Related investigational agents.
• CMV prophylaxis.
• Systemic acyclovir.
• Any nephrotoxic agent.
• Any concomitant therapy that would prohibit use of ganciclovir.

Prior Medication:

Excluded:

• Prior treatment for CMV retinitis.
• More than 4 months of prior ganciclovir or foscarnet, or within 4 weeks prior to study entry.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Holland GN

Role: STUDY_CHAIR

Hardy WD

Role: STUDY_CHAIR

Locations

UCLA CARE Center CRS

Los Angeles, California, United States

Rush Univ. Med. Ctr. ACTG CRS

Chicago, Illinois, United States

Johns Hopkins Adult AIDS CRS

Baltimore, Maryland, United States

Cornell University A2201

New York, New York, United States

Unc Aids Crs

Chapel Hill, North Carolina, United States

University of Washington AIDS CRS

Seattle, Washington, United States

Countries

United States

References

Danner SA, Matheron S. Cytomegalovirus retinitis in AIDS patients: a comparative study of intravenous and oral ganciclovir as maintenance therapy. AIDS. 1996 Dec;10 Suppl 4:S7-11.

Reference Type: BACKGROUND

PMID: 9110064 (View on PubMed)

Other Identifiers

11254

Identifier Type: REGISTRY

Identifier Source: secondary_id

ACTG 278

Identifier Type: -

Identifier Source: org_study_id