Trial Outcomes & Findings for Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT) (NCT NCT00000143)

NCT ID: NCT00000143

Last Updated: 2016-03-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 61 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2016-03-14

Participant Flow

June 1997

Participant milestones

Measure	Ganciclovir Implant and Oral Ganciclovir Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily	Cidofovir IV (Intravenous) cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week
Overall Study STARTED	31	30
Overall Study COMPLETED	31	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)

Baseline characteristics by cohort

Measure	Ganciclovir Implant and Oral Ganciclovir n=31 Participants Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily	Cidofovir IV (Intravenous) n=30 Participants cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week	Total n=61 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	31 Participants n=5 Participants	30 Participants n=7 Participants	61 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	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants	30 participants n=7 Participants	61 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Outcome measures

Measure	Ganciclovir Implant and Oral Ganciclovir n=31 Participants Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily	Cidofovir IV (Intravenous) n=30 Participants cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week
Survival	31 participants	30 participants

Adverse Events

Ganciclovir Implant and Oral Ganciclovir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cidofovir IV (Intravenous)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Curtis Meinert, PhD

Johns Hopkins School of Public Health

Phone: 410-955-8198

Email: cmeinert@jhsph.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place