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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Johns Hopkins University |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000665 |
To evaluate the relative effectiveness and safety of foscarnet versus ganciclovir for the treatment of cytomegalovirus (CMV) retinitis in people with AIDS; to evaluate the relative effect on survival of the use of these two anti-CMV agents in the treatment of CMV retinitis; to compare the relative benefits of immediate treatment with foscarnet or ganciclovir versus deferral of treatment for CMV retinitis limited to less than 25 percent of zones 2 and 3.
CMV retinitis is a common opportunistic infection in patients with AIDS. Ganciclovir is currently the only drug approved for treatment of CMV retinitis in immunocompromised patients. Ganciclovir suppresses CMV infections, and relapse occurs in virtually all AIDS patients when ganciclovir is discontinued. Because of their similar hematologic (blood) toxicities, the simultaneous use of ganciclovir and zidovudine (AZT) is not recommended. More recently the drug foscarnet has become available for investigational use. Studies so far indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients, and that relapse occurs in virtually all patients when the drug is discontinued. The relative effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV infections is unknown. Further, the long-term effects of foscarnet or ganciclovir on CMV retinitis, survival, and morbidity are unknown. There is also no definitive information on the relative effectiveness and safety of deferred versus immediate treatment for CMV retinitis confined to zones 2 and 3.
Condition | Intervention |
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Cytomegalovirus Retinitis HIV Infections |
Drug: Foscarnet sodium Drug: Ganciclovir |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component |
Estimated Enrollment: | 240 |
CMV retinitis is a common opportunistic infection in patients with AIDS. Ganciclovir is currently the only drug approved for treatment of CMV retinitis in immunocompromised patients. Ganciclovir suppresses CMV infections, and relapse occurs in virtually all AIDS patients when ganciclovir is discontinued. Because of their similar hematologic (blood) toxicities, the simultaneous use of ganciclovir and zidovudine (AZT) is not recommended. More recently the drug foscarnet has become available for investigational use. Studies so far indicate that remission of CMV retinitis occurs in 36 to 77 percent of patients, and that relapse occurs in virtually all patients when the drug is discontinued. The relative effectiveness of foscarnet compared with ganciclovir for the immediate control of CMV infections is unknown. Further, the long-term effects of foscarnet or ganciclovir on CMV retinitis, survival, and morbidity are unknown. There is also no definitive information on the relative effectiveness and safety of deferred versus immediate treatment for CMV retinitis confined to zones 2 and 3.
Patients are assigned to one of two groups: (1) Patients with any retinitis in zone 1 or patients with retinitis involving 25 percent or more of zones 2 and 3; and (2) Patients in whom retinitis is confined to less than 25 percent of zones 2 and 3 of the retina. Half the patients in group 1 get immediate treatment with ganciclovir; the other half receive immediate treatment with foscarnet. Patients in group 2 are treated with foscarnet or ganciclovir either immediately or treatment is deferred. If patients in group 2 have strong preferences regarding when therapy is instituted, they may elect immediate treatment or deferral of treatment.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Concurrent Medication:
Allowed:
Patients must have:
Prior Medication:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
Concurrent Medication:
Excluded:
Patients with the following are excluded:
Prior Medication:
Excluded:
Active intravenous drug or alcohol abuse, sufficient in the investigator's opinion to prevent adequate compliance with study therapy and follow-up.
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, Louisiana | |
Charity Hosp / Tulane Univ Med School | |
New Orleans, Louisiana, United States, 70112 | |
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 |
Study ID Numbers: | ACTG 129, FDA 46A, FDA/00095 |
Study First Received: | November 2, 1999 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00000665 |
Health Authority: | United States: Federal Government |
Retinitis AIDS-Related Opportunistic Infections Ganciclovir Foscarnet |
Cytomegalovirus Infections Acquired Immunodeficiency Syndrome Antiviral Agents |
Opportunistic Infections 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 AIDS-Related Opportunistic 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 |