A Study of Ganciclovir in the Treatment of Cytomegalovirus of the Eyes
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Ganciclovir |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | 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 |
| Estimated Enrollment: | 25 |
| Study Completion Date: | January 1998 |
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| Ages Eligible for Study: | 13 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| United States, California | |
| UCLA CARE Center CRS | |
| Los Angeles, California, United States, 90095 | |
| United States, Illinois | |
| Rush Univ. Med. Ctr. ACTG CRS | |
| Chicago, Illinois, United States | |
| United States, Maryland | |
| Johns Hopkins Adult AIDS CRS | |
| Baltimore, Maryland, United States, 21287 | |
| United States, New York | |
| Cornell University A2201 | |
| New York, New York, United States, 10021 | |
| United States, North Carolina | |
| Unc Aids Crs | |
| Chapel Hill, North Carolina, United States, 27599 | |
| United States, Washington | |
| University of Washington AIDS CRS | |
| Seattle, Washington, United States, 98122 | |
| Study Chair: | Holland GN | |
| Study Chair: | Hardy WD |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001062 History of Changes |
| Other Study ID Numbers: | ACTG 278, 11254 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Infusions, Intravenous Ganciclovir Administration, Oral |
Acquired Immunodeficiency Syndrome Antiviral Agents Cytomegalovirus Retinitis |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on March 10, 2013
