Trial Outcomes & Findings for Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT) (NCT NCT00000134)

NCT ID: NCT00000134

Last Updated: 2015-09-14

Results Overview

To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 279 participants
• Primary outcome timeframe: Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial
• Results posted on: 2015-09-14

Participant Flow

December 1992

Participant milestones

Measure	Intravenous Foscarnet intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day	Intravenous Ganciclovir intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day	Combination Therapy combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day. Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Overall Study STARTED	89	94	96
Overall Study COMPLETED	89	94	96
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Studies of the Ocular Complications of AIDS (SOCA)--Cytomegalovirus Retinitis Retreatment Trial (CRRT)

Baseline characteristics by cohort

Measure	Intravenous Foscarnet n=89 Participants intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day	Intravenous Ganciclovir n=94 Participants intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day	Combination Therapy n=96 Participants combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day. Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day	Total n=279 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	89 Participants n=5 Participants	94 Participants n=7 Participants	96 Participants n=5 Participants	279 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	82 Participants n=5 Participants	88 Participants n=7 Participants	86 Participants n=5 Participants	256 Participants n=4 Participants
Region of Enrollment United States	89 participants n=5 Participants	94 participants n=7 Participants	96 participants n=5 Participants	279 participants n=4 Participants

PRIMARY outcome

Timeframe: Patients will be seen at baseline, monthly for six months, and then every three months until death or termination of the trial

To determine the best therapeutic regimen, using currently approved drugs, for treatment of relapsed cytomegalovirus (CMV) retinitis.

Outcome measures

Measure	Intravenous Foscarnet n=88 Participants intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day	Intravenous Ganciclovir n=93 Participants intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day	Combination Therapy n=93 Participants combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day. Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Morbidity	88 participants	93 participants	93 participants

Adverse Events

Intravenous Foscarnet

Serious events: 32 serious events

Other events: 7 other events

Deaths: 0 deaths

Intravenous Ganciclovir

Serious events: 41 serious events

Other events: 7 other events

Deaths: 0 deaths

Combination Therapy

Serious events: 51 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intravenous Foscarnet n=88 participants at risk intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day	Intravenous Ganciclovir n=93 participants at risk intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day	Combination Therapy n=93 participants at risk combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day. Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Blood and lymphatic system disorders Neutropenia	36.4% 32/88 • Number of events 86 • 1 year, 4 months	44.1% 41/93 • Number of events 95 • 1 year, 4 months	54.8% 51/93 • Number of events 107 • 1 year, 4 months
Blood and lymphatic system disorders Thrombocytopenia	15.9% 14/88 • Number of events 28 • 1 year, 4 months	8.6% 8/93 • Number of events 19 • 1 year, 4 months	16.1% 15/93 • Number of events 40 • 1 year, 4 months

Other adverse events

Measure	Intravenous Foscarnet n=88 participants at risk intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day	Intravenous Ganciclovir n=93 participants at risk intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day	Combination Therapy n=93 participants at risk combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day. Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day
Infections and infestations Hospitalizations	8.0% 7/88 • Number of events 9 • 1 year, 4 months	7.5% 7/93 • Number of events 10 • 1 year, 4 months	10.8% 10/93 • Number of events 11 • 1 year, 4 months

Additional Information

Curtis Meinert, PhD

Johns Hopkins University

Phone: 410-955-8198

Email: cmeinert@jhsph.edu

Results disclosure agreements

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

Restriction type: GT60