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Home > "A" Clinical Trials Conditions > A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes  A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
For Condition: Cytomegalovirus Retinitis,HIV Infections
Status: Completed
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 13 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 25
Location and Contact Information:
Overall Study Official:
HollandGN, Study Chair,
Illinois Masonic Med Ctr
Chicago, Illinois, 606575147
United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215
United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, 60640
United States
Saint Clare's Hosp and Health Ctr
New York City, New York, 10019
United States
Cornell Univ Med Ctr
New York City, New York, 10021
United States
Univ of Washington
Seattle, Washington, 981224304
United States
UCLA CARE Ctr
Los Angeles, California, 90095
United States
Lakeside Veterans Adm / Northwestern Univ Med School
Chicago, Illinois, 60611
United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287
United States
Additional Information:
Study ID Numbers: ACTG 278;
Study Start Date:
Record last reviewed: December 1996
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001062
Other Cytomegalovirus Retinitis Studies:
1. The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients with HIV
2. The Safety and Effectiveness of Cidofovir in the Treatment of Cytomegalovirus (CMV) of the Eyes in Patients with AIDS
3. A Pilot Study to Obtain Preliminary Information Regarding the Efficacy and Safety of the Combination of Immune Globulin and Ganciclovir as Compared to Ganciclovir Alone in the Treatment of Sight-Threatening CMV Retinitis in Patients With AIDS
4. A Phase I Study of the Safety of Proleukin (aldesleukin) in Combination with Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis
5. Open Label Ganciclovir Therapy for Sight- or Life-Threatening Cytomegalovirus Disease in the Immunocompromised Patient
Related Studies:
Other Cytomegalovirus Retinitis Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
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