Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)
CRRT
Cytomegalovirus Retinitis Retreatment Trial
3 other identifiers
interventional
279
0 countries
N/A
Brief Summary
To compare the relative merits of three therapeutic regimens in patients with AIDS and CMV retinitis who have been previously treated but whose retinitis either is nonresponsive or has relapsed. These three therapeutic regimens were (1) foscarnet, (2) high-dose ganciclovir, and (3) combination foscarnet and ganciclovir. To compare two treatment strategies in patients with relapsed or nonresponsive CMV retinitis: (1) continuing the same anti-CMV drug or (2) switching to the alternate drug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 hiv-infections
Started Dec 1992
Shorter than P25 for phase_3 hiv-infections
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1992
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 1995
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 1995
CompletedFirst Submitted
Initial submission to the registry
September 23, 1999
CompletedFirst Posted
Study publicly available on registry
September 24, 1999
CompletedResults Posted
Study results publicly available
September 14, 2015
CompletedSeptember 14, 2015
August 1, 2015
2.2 years
September 23, 1999
June 15, 2015
August 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Morbidity
To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.
Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial
Study Arms (3)
intravenous foscarnet
EXPERIMENTALintravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
intravenous ganciclovir
ACTIVE COMPARATORintravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
combination therapy
ACTIVE COMPARATORcombination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.
Interventions
intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day
intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johns Hopkins Bloomberg School of Public Healthlead
- National Eye Institute (NEI)collaborator
- National Institute of Allergy and Infectious Diseases (NIAID)collaborator
- Johns Hopkins Universitycollaborator
- University of Wisconsin, Madisoncollaborator
- Baylor College of Medicinecollaborator
- Tulane University School of Medicinecollaborator
- Icahn School of Medicine at Mount Sinaicollaborator
- New York Presbyterian Hospitalcollaborator
- New York Universitycollaborator
- Northwestern Universitycollaborator
- University of California, Los Angelescollaborator
- University of California, San Franciscocollaborator
- University of California, San Diegocollaborator
- University of Miamicollaborator
- University of North Carolina, Chapel Hillcollaborator
- Memorial Sloan Kettering Cancer Centercollaborator
Related Publications (2)
Combination foscarnet and ganciclovir therapy vs monotherapy for the treatment of relapsed cytomegalovirus retinitis in patients with AIDS. The Cytomegalovirus Retreatment Trial. The Studies of Ocular Complications of AIDS Research Group in Collaboration with the AIDS Clinical Trials Group. Arch Ophthalmol. 1996 Jan;114(1):23-33. doi: 10.1001/archopht.1996.01100130021004.
PMID: 8540847BACKGROUNDMartin BK, Kaplan Gilpin AM, Jabs DA, Wu AW; Studies of Ocular Complications of AIDS Research Group. Reliability, validity, and responsiveness of general and disease-specific quality of life measures in a clinical trial for cytomegalovirus retinitis. J Clin Epidemiol. 2001 Apr;54(4):376-86. doi: 10.1016/s0895-4356(00)00294-8.
PMID: 11305288BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Curtis Meinert, PhD
- Organization
- Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Curtis Meinert, PhD
Study Record Dates
First Submitted
September 23, 1999
First Posted
September 24, 1999
Study Start
December 1, 1992
Primary Completion
March 1, 1995
Study Completion
March 1, 1995
Last Updated
September 14, 2015
Results First Posted
September 14, 2015
Record last verified: 2015-08