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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00001062

Collaborator

(none)

Enrollment

Locations

4.2

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Ganciclovir	Phase 1

Detailed Description

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

A Phase I Study of a Fixed-Schedule Regimen of Alternating Oral and Intravenous Ganciclovir for Treatment of Cytomegalovirus Retinitis

Actual Study Completion Date :

Jan 1, 1998

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA CARE Center CRS	Los Angeles	California	United States	90095
2	Rush Univ. Med. Ctr. ACTG CRS	Chicago	Illinois	United States
3	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland	United States	21287
4	Cornell University A2201	New York	New York	United States	10021
5	Unc Aids Crs	Chapel Hill	North Carolina	United States	27599
6	University of Washington AIDS CRS	Seattle	Washington	United States	98122