Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000142
Status:
COMPLETED
Last Update Posted:
2015-11-17
First Post:
1999-09-23
Brief Title:
Studies of the Ocular Complications of AIDS SOCA--HPMPC Peripheral CMV Retinitis Trial HPCRT
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Studies of the Ocular Complications of AIDS SOCA--HPMPC Peripheral CMV Retinitis Trial HPCRT
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPCRT
Brief Summary:
To test and evaluate the efficacy and safety of intravenous cidofovir Vistide previously known as HPMPC for the treatment of retinitis
Detailed Description:
CMV cytomegalovirus retinitis is the most common intraocular infection in patients with AIDS and is estimated to affect 35 percent to 40 percent of patients with AIDS Untreated CMV cytomegalovirus retinitis is a progressive disorder the end result of which is total retinal destruction and blindness As of September 1997 drugs approved by the United States Food and Drug Administration FDA for the treatment of CMV cytomegalovirusretinitis were ganciclovir Cytovene foscarnet Foscavir and cidofovir Vistide Cidofovir has a prolonged duration of effect permitting intermittent administration All systemically administered anti-CMV drugs are given in a similar fashion consisting of initial 2-week high-dose treatment induction to control the infection followed by long-term lower dose treatment maintenance to prevent relapse Cidofovir is administered as an intravenous infusion once weekly for induction therapy and once every 2 weeks as maintenance therapy The HPCRT evaluated the efficacy and safety of cidofovir therapy
The HPCRT was a multicenter randomized controlled clinical trial of cidofovir for the treatment of CMV cytomegalovirus retinitis Patients with small peripheral CMV cytomegalovirus retinitis lesions ie not at risk of immediate loss of visual acuity were randomized to immediate treatment with cidofovir or deferred therapy until the retinitis had progressed Patients randomized to immediate therapy received either 1 low-dose cidofovir at 5 mgkg once weekly induction for 2 weeks followed by 3 mgkg once every 2 weeks for maintenance or 2 high-dose cidofovir at 5 mgkg once weekly induction for 2 weeks followed by 5 mgkg once every 2 weeks for maintenance Patients whose retinitis progressed were given treatment according to best medical judgement and those assigned to deferral were generally treated with cidofovir
Outcomes in this trial included retinitis progression loss of retinal area and morbidity
The HPCRT was a multicenter randomized controlled clinical trial of cidofovir for the treatment of CMV cytomegalovirus retinitis Patients with small peripheral CMV cytomegalovirus retinitis lesions ie not at risk of immediate loss of visual acuity were randomized to immediate treatment with cidofovir or deferred therapy until the retinitis had progressed Patients randomized to immediate therapy received either 1 low-dose cidofovir at 5 mgkg once weekly induction for 2 weeks followed by 3 mgkg once every 2 weeks for maintenance or 2 high-dose cidofovir at 5 mgkg once weekly induction for 2 weeks followed by 5 mgkg once every 2 weeks for maintenance Patients whose retinitis progressed were given treatment according to best medical judgement and those assigned to deferral were generally treated with cidofovir
Outcomes in this trial included retinitis progression loss of retinal area and morbidity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None