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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

What the finished NCT00000665 record still lists

NCT00000665 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 445-participant average among 542 other HIV Infections trials with a reported enrollment target (46% lower).

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 lists 9 locations in 5 states (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.

Learn More About Clinical Trials

Similar trials for HIV Infections

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00000665's enrollment target sits among peer trials

240 150th of 542 higher than 391 of 542 other HIV Infections trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00000665, the US trial registry maintained by the National Library of Medicine. NCT00000665 (mid enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.