Phase 3
N=279
Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)
HIV Infections · Acquired Immunodeficiency Syndrome · Cytomegalovirus Retinitis
Bottom Line
View on ClinicalTrials.gov: NCT00000134 ↗Enrolled (actual)
279
Serious AEs
45.3%
Results posted
Sep 2015
Primary outcome: Primary: Morbidity — 88; 93; 93 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ganciclovir (Drug); Foscarnet (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Mar 1995
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morbidity |
88; 93; 93 | — |
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.
Eligibility Criteria
inclusion criteria: Males and females eligible for the CRRT must have been age 18 years or older and have had AIDS and CMV retinitis. They must have had active CMV despite a minimum of 28 days of previous treatment with an anti-CMV drug. Furthermore, they must have had an absolute neutrophil count greater than or equal to 500 cells/µL, platelet count greater than or equal to 20,000 cells/µL, and a serum creatinine < 2.5 mg/dL in order to tolerate the drug regimens.
exclusion criteria: history of intolerance to ganciclovir or foscarnet, history of therapy involving the combination of foscarnet and ganciclovir, unwillingness to practice appropriate birth control, active drug or alcohol abuse, media opacity, retinal detachment not scheduled for surgical repair
Data sourced from ClinicalTrials.gov (NCT00000134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.