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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000766 |
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 |
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Cytomegalovirus Retinitis HIV Infections |
Drug: Foscarnet sodium Drug: Ganciclovir |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Safety Study |
Official Title: | CMV Retinitis Retreatment Trial |
Estimated Enrollment: | 300 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Required:
Concurrent Medication:
Allowed:
Recommended:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms and conditions are excluded:
Patients with the following prior conditions are excluded:
Active drug or alcohol abuse sufficient to prevent compliance.
United States, California | |
UCSF - San Francisco Gen Hosp | |
San Francisco, California, United States, 94143 | |
UCSD - Shiley Eye Ctr / SOCA | |
La Jolla, California, United States, 920930946 | |
UCLA - Jules Stein Eye Institute / SOCA | |
Los Angeles, California, United States, 900957003 | |
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 |
Study ID Numbers: | ACTG 228 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000766 |
Health Authority: | United States: Federal Government |
Retinitis Ganciclovir Foscarnet Cytomegalovirus Infections Acquired Immunodeficiency Syndrome |
Phosphonoacetic Acid Sexually Transmitted Diseases, Viral Eye Diseases Eye Infections Acquired Immunodeficiency Syndrome Cytomegalovirus Retinitis Retinitis Ganciclovir Cytomegalovirus Immunologic Deficiency Syndromes Herpesviridae Infections |
Cytomegalovirus retinitis Virus Diseases HIV Infections Sexually Transmitted Diseases Cytomegalovirus Infections DNA Virus Infections Foscarnet Cytomegalic inclusion disease Retroviridae Infections Retinal Diseases |
Anti-Infective Agents RNA Virus Infections Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Immune System Diseases Eye Infections, Viral Enzyme Inhibitors Infection |
Antiviral Agents Pharmacologic Actions Reverse Transcriptase Inhibitors Anti-Retroviral Agents Therapeutic Uses Lentivirus Infections Nucleic Acid Synthesis Inhibitors |