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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001062
• Other study ID #: ACTG 278
• Secondary ID: 11254
• Status: Completed
• Phase: Phase 1
• Est. completion date: January 1998

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 1998
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Ganciclovir

Locations

Country	Name	City	State
United States	Johns Hopkins Adult AIDS CRS	Baltimore	Maryland
United States	Unc Aids Crs	Chapel Hill	North Carolina
United States	Rush Univ. Med. Ctr. ACTG CRS	Chicago	Illinois
United States	UCLA CARE Center CRS	Los Angeles	California
United States	Cornell University A2201	New York	New York
United States	University of Washington AIDS CRS	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation