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NCT00000665 · ClinicalTrials.gov registry record · NA

Studies of the Ocular Complications of AIDS (SOCA) CMV Retinitis Trial: Foscarnet-Ganciclovir Component

A NA study of HIV Infections and Cytomegalovirus Retinitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
NA
Development phase
240
Enrollment target
9
Study locations

NCT00000665 is a NA study of HIV Infections and Cytomegalovirus Retinitis that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 240 participants, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (46% lower). The trial reports 9 study locations across 5 states.

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The verdict

NCT00000665, a NA study of HIV Infections and Cytomegalovirus Retinitis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
NA
Development phase
240 participants
Enrollment target
9
Study locations

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

HIV Infections Cytomegalovirus Retinitis

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

FieldValue
Enrollment Target 240 participants
Phase NA

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

Interested in This Trial?

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, categorized as NA. The registered enrollment target is 240 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (46% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

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.

NCT00000665 reports 9 study locations spanning 5 distinct geographic areas - top geographies include California, New York, Illinois.

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.

What interventions are being tested in trial NCT00000665?

The interventions under investigation include: Foscarnet sodium (DRUG), Ganciclovir (DRUG).

Who is sponsoring clinical trial NCT00000665?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.