CMV Retinitis Retreatment Trial
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Purpose
To assess the safety and efficacy of three therapeutic regimens (foscarnet, ganciclovir, or the combination) for recurrent or persistent AIDS-related cytomegalovirus (CMV) retinitis.
Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.
| Condition | Intervention | Phase |
|---|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Foscarnet sodium Drug: Ganciclovir |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | CMV Retinitis Retreatment Trial |
| Estimated Enrollment: | 300 |
| Primary Completion Date: | September 1995 (Final data collection date for primary outcome measure) |
Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.
Patients are randomized to receive foscarnet, ganciclovir, or a combination of the two drugs (administered sequentially). Initially, patients undergo single or multiple cycles of induction therapy for 14 days followed by maintenance therapy. Patients in whom the retinitis continues to progress or who are intolerant of the initial treatment switch to the alternative drug for further cycles of induction and maintenance. Patients on the combination arm in whom retinitis continues to progress are given further cycles of the combination at an increased dose, or, if one drug is causing toxicity, are given further cycles with the alternative drug. Patients are followed monthly for 6 months and then every 3 months thereafter.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Required:
- At least 28 days of prior foscarnet or ganciclovir.
Concurrent Medication:
Allowed:
- G-CSF.
Recommended:
- Antiretroviral therapy.
Patients must have:
- HIV infection or AIDS.
- Active CMV retinitis after 28 or more days of either foscarnet or ganciclovir therapy.
- At least one lesion with one-quarter disk area or more that can be photographed.
- Visual acuity of 3 or more letters on ETDRS chart (5/200 Snellen) in an affected eye.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
- Media opacity severe enough to preclude visualization of both fundi.
- Retinal detachment not scheduled for surgical repair.
Patients with the following prior conditions are excluded:
- History of intolerance to ganciclovir or foscarnet sufficient to contraindicate use.
- History of combination foscarnet/ganciclovir therapy.
Active drug or alcohol abuse sufficient to prevent compliance.
Contacts and Locations| United States, California | |
| UCSD - Shiley Eye Ctr / SOCA | |
| La Jolla, California, United States, 920930946 | |
| UCLA - Jules Stein Eye Institute / SOCA | |
| Los Angeles, California, United States, 900957003 | |
| UCSF - San Francisco Gen Hosp | |
| San Francisco, California, United States, 94143 | |
| United States, Illinois | |
| Northwestern Univ / SOCA | |
| Chicago, Illinois, United States, 60611 | |
| United States, Maryland | |
| Johns Hopkins Hosp / SOCA | |
| Baltimore, Maryland, United States, 212879217 | |
| United States, New York | |
| New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA | |
| New York, New York, United States, 10021 | |
| Mount Sinai Med Ctr / SOCA | |
| New York, New York, United States, 100296574 | |
| New York Univ Med Ctr / SOCA | |
| New York, New York, United States, 10016 | |
| United States, North Carolina | |
| Univ of North Carolina / SOCA | |
| Chapel Hill, North Carolina, United States, 275997030 | |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00000766 History of Changes |
| Other Study ID Numbers: | ACTG 228 |
| Study First Received: | November 2, 1999 |
| Last Updated: | February 28, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Retinitis Ganciclovir Foscarnet Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
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 Foscarnet Phosphonoacetic Acid Ganciclovir Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013