drugset / Trial / NCT00000134
Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)
Phase 3
Completed
279 enrolled
Johns Hopkins Bloomberg School of Public Health
Baylor College of Medicine · collabIcahn School of Medicine at Mount Sinai · collabJohns Hopkins University · collabMemorial Sloan Kettering Cancer Center · collabNational Eye Institute (NEI) · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collabNew York Presbyterian Hospital · collabNew York University · collabNorthwestern University · collabTulane University School of Medicine · collabUniversity of California, Los Angeles · collabUniversity of California, San Diego · collabUniversity of California, San Francisco · collabUniversity of Miami · collabUniversity of North Carolina, Chapel Hill · collabUniversity of Wisconsin, Madison · collab
RandomizedFactorialDouble-blindTreatment
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.
Timeline
- Start
- 1992-12
- Primary completion
- 1995-03
- Completion
- 1995-03
Publications
- Background 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.
- Background Martin 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Foscarnet | Small molecule | 120 mg/kg | Intravenous |
| Comparator | Ganciclovir | Small molecule | 10 mg/kg | Intravenous |