search
Back to results

CMV Retinitis Retreatment Trial

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Foscarnet sodium
Ganciclovir
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring Retinitis, Ganciclovir, Foscarnet, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Required: At least 28 days of prior foscarnet or ganciclovir. Concurrent Medication: Allowed: G-CSF. Recommended: Antiretroviral therapy. Patients must have: HIV infection or AIDS. Active CMV retinitis after 28 or more days of either foscarnet or ganciclovir therapy. At least one lesion with one-quarter disk area or more that can be photographed. Visual acuity of 3 or more letters on ETDRS chart (5/200 Snellen) in an affected eye. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Media opacity severe enough to preclude visualization of both fundi. Retinal detachment not scheduled for surgical repair. Patients with the following prior conditions are excluded: History of intolerance to ganciclovir or foscarnet sufficient to contraindicate use. History of combination foscarnet/ganciclovir therapy. Active drug or alcohol abuse sufficient to prevent compliance.

Sites / Locations

  • UCSD - Shiley Eye Ctr / SOCA
  • UCLA - Jules Stein Eye Institute / SOCA
  • UCSF - San Francisco Gen Hosp
  • Northwestern Univ / SOCA
  • Johns Hopkins Hosp / SOCA
  • New York Univ Med Ctr / SOCA
  • New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA
  • Mount Sinai Med Ctr / SOCA
  • Univ of North Carolina / SOCA

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
February 28, 2011
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT00000766
Brief Title
CMV Retinitis Retreatment Trial
Official Title
CMV Retinitis Retreatment Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
September 1995 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
To assess the safety and efficacy of three therapeutic regimens (foscarnet, ganciclovir, or the combination) for recurrent or persistent AIDS-related cytomegalovirus (CMV) retinitis. Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs.
Detailed Description
Although therapy with foscarnet or ganciclovir halts retinitis progression in 90 percent of patients treated, relapses are common and may accelerate due to development of drug resistance, deteriorating immune function, or other factors. Treatment strategies currently being investigated include switching patients from one drug to the other or combining the two drugs. Patients are randomized to receive foscarnet, ganciclovir, or a combination of the two drugs (administered sequentially). Initially, patients undergo single or multiple cycles of induction therapy for 14 days followed by maintenance therapy. Patients in whom the retinitis continues to progress or who are intolerant of the initial treatment switch to the alternative drug for further cycles of induction and maintenance. Patients on the combination arm in whom retinitis continues to progress are given further cycles of the combination at an increased dose, or, if one drug is causing toxicity, are given further cycles with the alternative drug. Patients are followed monthly for 6 months and then every 3 months thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
Retinitis, Ganciclovir, Foscarnet, Cytomegalovirus Infections, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
300 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Foscarnet sodium
Intervention Type
Drug
Intervention Name(s)
Ganciclovir

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Required: At least 28 days of prior foscarnet or ganciclovir. Concurrent Medication: Allowed: G-CSF. Recommended: Antiretroviral therapy. Patients must have: HIV infection or AIDS. Active CMV retinitis after 28 or more days of either foscarnet or ganciclovir therapy. At least one lesion with one-quarter disk area or more that can be photographed. Visual acuity of 3 or more letters on ETDRS chart (5/200 Snellen) in an affected eye. Exclusion Criteria Co-existing Condition: Patients with the following symptoms and conditions are excluded: Media opacity severe enough to preclude visualization of both fundi. Retinal detachment not scheduled for surgical repair. Patients with the following prior conditions are excluded: History of intolerance to ganciclovir or foscarnet sufficient to contraindicate use. History of combination foscarnet/ganciclovir therapy. Active drug or alcohol abuse sufficient to prevent compliance.
Facility Information:
Facility Name
UCSD - Shiley Eye Ctr / SOCA
City
La Jolla
State/Province
California
ZIP/Postal Code
920930946
Country
United States
Facility Name
UCLA - Jules Stein Eye Institute / SOCA
City
Los Angeles
State/Province
California
ZIP/Postal Code
900957003
Country
United States
Facility Name
UCSF - San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Northwestern Univ / SOCA
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Johns Hopkins Hosp / SOCA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212879217
Country
United States
Facility Name
New York Univ Med Ctr / SOCA
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York Hosp - Cornell Med Ctr / Sloan - Kettering / SOCA
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Mount Sinai Med Ctr / SOCA
City
New York
State/Province
New York
ZIP/Postal Code
100296574
Country
United States
Facility Name
Univ of North Carolina / SOCA
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
275997030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8721550
Citation
Jabs DA. Design of clinical trials for drug combinations: cytomegalovirus retinitis--foscarnet and ganciclovir. The CMV retinitis retreatment trial. Antiviral Res. 1996 Jan;29(1):69-71. doi: 10.1016/0166-3542(95)00921-3.
Results Reference
background

Learn more about this trial

CMV Retinitis Retreatment Trial

We'll reach out to this number within 24 hrs