Phase 3
N=234
Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)
HIV Infections · Cytomegalovirus Retinitis
Bottom Line
View on ClinicalTrials.gov: NCT00000136 ↗Enrolled (actual)
234
Serious AEs
56.8%
Results posted
Oct 2015
Primary outcome: Primary: Mortality — 107; 127 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Foscarnet (Drug); Ganciclovir (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins Bloomberg School of Public Health
- Primary completion
- Oct 1991
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality |
107; 127 | — |
Summary
To evaluate the relative safety and efficacy of ganciclovir and foscarnet as initial treatment of patients with cytomegalovirus (CMV) retinitis.
Eligibility Criteria
Inclusion criteria
- CMV retinitis in one or both eyes
- At least 1/4 disk are of one CMV lesion photographable
- Diagnosis of AIDS as defined by Center for Disease Control criteria or documented HIV infection
- Age 13 and greater
- Visual acuity ≥ 3/200 in at least one eye diagnosed with CMV retinitis
- Absolute neutrophil count ≥ 1,000 cells/µl
- Platelet ≥ 25,000 cells/µl
- Serum creatinine ≥ 2.0 mg/dl
- Karnofsky score ≥ 60
- Informed consent
Exclusion criteria
- Previous treatment of CMV retinitis
- Treatment with anti-CMV therapy for an extra-ocular CMV infection currently or in the past 28 days
- Known or suspected allergy to study drugs
- Pregnant or Lactating
Data sourced from ClinicalTrials.gov (NCT00000136). 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.