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NCT00000691 · ClinicalTrials.gov registry record · Phase 2
A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure
A Phase 2 study of HIV Infections and Cytomegalovirus Retinitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 156
- Enrollment target
- 11
- Study locations
NCT00000691: Completed Phase 2 study of HIV Infections and Cytomegalovirus Retinitis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00000691 is a Phase 2 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 156 participants, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (65% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00000691, a Phase 2 study of HIV Infections and Cytomegalovirus Retinitis, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 156 participants
- Enrollment target
- 11
- Study locations
Study Summary
To examine the usefulness and safety of the antiviral drug foscarnet in treating AIDS patients with cytomegalovirus (CMV) infection that is causing sight-threatening inflammation of the retina in one or both eyes (CMV retinitis). Because of the seriousness of sight-threatening CMV retinitis in AIDS patients and a lack of other available treatments for those patients who cannot be treated with ganciclovir (DHPG) (because of its toxic effect on the body's blood-forming cells, because it did not control the disease, or because patient's blood cell or platelet counts are too low to begin with), it is worthwhile to try an immediate trial with foscarnet. AMENDED: ACTG 093 was originally designed as a randomized dose-ranging study of foscarnet maintenance therapy. Patients enrolled between March 17, 1989, and January 1, 1990, received either 60 mg/kg/day or 90/mg/kg day as maintenance therapy following the 2 week induction period. Based on the preliminary results of ACTG 015/915, which studied maintenance doses of foscarnet of 60 mg/kg/day, 90 mg/kg/day and 120 mg/kg/day, the 60-mg/kg/day and 90/mg/kg/day arms of this study have been closed. All patients entering the study beginning January 2, 1990 will receive foscarnet maintenance therapy on a 120/mg/kg/day algorithm following induction.
Conditions Studied
Interventions
- DRUG Foscarnet sodium
Study Locations (11)
New York
- SUNY - Buffalo, Erie County Medical Ctr. - Buffalo
- NY Univ. HIV/AIDS CRS - New York
- Cornell University A2201 - New York
- Univ. of Rochester ACTG CRS - Rochester
California
- USC CRS - Los Angeles
- Ucsf Aids Crs - San Francisco
Florida
- Univ. of Miami AIDS CRS - Miami
Maryland
- Johns Hopkins Adult AIDS CRS - Baltimore
Massachusetts
- Massachusetts General Hospital ACTG CRS - Boston
Missouri
- Washington U CRS - St Louis
North Carolina
- Duke Univ. Med. Ctr. Adult CRS - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Est. Completion | 1992-08 |
| Phase | Phase 2 |
What the finished NCT00000691 record still lists
NCT00000691 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 446-participant average among 542 other HIV Infections trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with HIV Infections appearing as the primary indexed condition, and to 1 intervention - of which Foscarnet sodium is the first listed.
NCT00000691 lists 11 locations in 7 states (New York, California, Florida).
Frequently Asked Questions
What is clinical trial NCT00000691 about?
NCT00000691 is a clinical study titled "A Phase II Dose-Ranging, Open-Labelled Trial of Foscarnet Salvage Therapy for AIDS Patients With Sight-Threatening CMV Retinitis Who Cannot Be Treated With Ganciclovir Due To Myelosuppression or Treatment Failure". To examine the usefulness and safety of the antiviral drug foscarnet in treating AIDS patients with cytomegalovirus (CMV) infection that is causing sight-threatening inflammation of the retina in one or both eyes (CMV retinitis). Because of the seriousness of sight-threatening CMV retinitis in AIDS ...
What is the current status of trial NCT00000691?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 156 participants. Estimated completion is 1992-08.
What conditions does trial NCT00000691 study?
This clinical trial studies the following conditions: HIV Infections, Cytomegalovirus Retinitis.
What interventions are being tested in trial NCT00000691?
The interventions under investigation include: Foscarnet sodium (DRUG).
Who is sponsoring clinical trial NCT00000691?
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 NCT00000691 being conducted?
This trial has 11 study locations across California, Florida, Maryland, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT00000691's enrollment target sits among peer trials
156 207th of 542 higher than 335 of 542 other HIV Infections trials
participants (enrollment target), bucketed by value
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