Trial Outcomes & Findings for Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT) (NCT NCT00000136)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

234 participants

Primary outcome timeframe

All patients enrolled will be followed until a common study closing date, which was chosen to provide a minimum of 1 year of follow-up for all patients enrolled in the trial.

Results posted on

2015-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Foscarnet The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours	Ganciclovir The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week. Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours
Overall Study STARTED	107	127
Overall Study COMPLETED	107	127
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Studies of the Ocular Complications of AIDS (SOCA)--Foscarnet-Ganciclovir CMV Retinitis Trial (FGCRT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Foscarnet n=107 Participants The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours	Ganciclovir n=127 Participants The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week. Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours	Total n=234 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	107 Participants n=5 Participants	127 Participants n=7 Participants	234 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	98 Participants n=5 Participants	116 Participants n=7 Participants	214 Participants n=5 Participants
Region of Enrollment United States	107 participants n=5 Participants	127 participants n=7 Participants	234 participants n=5 Participants

PRIMARY outcome

Timeframe: All patients enrolled will be followed until a common study closing date, which was chosen to provide a minimum of 1 year of follow-up for all patients enrolled in the trial.

Outcome measures

Outcome measures
Measure	Foscarnet n=107 Participants The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours	Ganciclovir n=127 Participants The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week. Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours
Mortality	107 participants	127 participants

Adverse Events

Foscarnet

Serious events: 60 serious events

Other events: 0 other events

Deaths: 0 deaths

Ganciclovir

Serious events: 73 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Foscarnet n=107 participants at risk The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours	Ganciclovir n=127 participants at risk The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week. Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours
Immune system disorders Opportunistic Infection	56.1% 60/107 • Number of events 153 • 1 year, 7 months	57.5% 73/127 • Number of events 180 • 1 year, 7 months

Other adverse events

Adverse event data not reported

Additional Information

Curtis Meinert, PhD

The Johns Hopkins University

Phone: 410-955-8198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place