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Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component
NCT00000665 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Foscarnet sodium
- DRUG Ganciclovir
Study Locations (9)
California
- UCSD - Shiley Eye Ctr / SOCA — La Jolla
- UCLA - Jules Stein Eye Institute / SOCA — Los Angeles
- UCSF - San Francisco Gen Hosp — San Francisco
New York
- New York Univ Med Ctr / SOCA — New York
- New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA — New York
- Mount Sinai Med Ctr / SOCA — New York
Illinois
- Northwestern Univ / SOCA — Chicago
Louisiana
- Charity Hosp / Tulane Univ Med School — New Orleans
Maryland
- Johns Hopkins Hosp / SOCA — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00000665
The ClinicalTrials.gov registry entry for NCT00000665 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 2 interventions — of which Foscarnet sodium is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00000665 reports 9 study locations spanning 5 distinct geographic areas — top geographies include California, New York, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00000665 about?
NCT00000665 is a clinical study titled "Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component". 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 b...
What is the current status of trial NCT00000665?
This trial is currently completed. It is a NA study. The enrollment target is 240 participants.
What conditions does trial NCT00000665 study?
This clinical trial studies the following conditions: HIV Infections, Cytomegalovirus Retinitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00000665?
The interventions under investigation include: Foscarnet sodium (DRUG), Ganciclovir (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00000665?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 1,295 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00000665 being conducted?
This trial has 9 study locations across California, Illinois, Louisiana, Maryland, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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