Trial Outcomes & Findings for Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT) (NCT NCT00000135)

Results Overview

to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

209 participants

Primary outcome timeframe

All patients enrolled were followed for a 17 month period or until a common study closing date

Results posted on

2015-11-17

Participant Flow

Randomization was stratified on the basis of whether patients had untreated or relapsed retinitis. Primary drug therapy for CMV retinitis was determined by the treating physician.

Two hundred and nine patients with acquired immunodeficiency syndrome and active CMV retinitis were enrolled in a multicenter, phase 2/3, randomized, placebo controlled clinical trial. Patients received adjuvant treatment with MSL-109, 60mg intravenously every 2 weeks, or placebo,.

Participant milestones

Participant milestones
Measure	MSL-109 The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg. MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.	Placebo Placebo administered intravenous infusion every 2 weeks 60 mg. MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
Overall Study STARTED	104	105
Overall Study COMPLETED	77	91
Overall Study NOT COMPLETED	27	14

Reasons for withdrawal

Reasons for withdrawal
Measure	MSL-109 The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg. MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.	Placebo Placebo administered intravenous infusion every 2 weeks 60 mg. MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
Overall Study Death	27	14

Baseline Characteristics

Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MSL-109 n=104 Participants The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg. MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.	Placebo n=105 Participants Placebo administered intravenous infusion every 2 weeks 60 mg. MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.	Total n=209 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	104 Participants n=39 Participants	105 Participants n=41 Participants	209 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Sex: Female, Male Female	11 Participants n=39 Participants	11 Participants n=41 Participants	22 Participants n=35 Participants
Sex: Female, Male Male	93 Participants n=39 Participants	94 Participants n=41 Participants	187 Participants n=35 Participants
Region of Enrollment United States	104 participants n=39 Participants	105 participants n=41 Participants	209 participants n=35 Participants

PRIMARY outcome

Timeframe: All patients enrolled were followed for a 17 month period or until a common study closing date

to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .

Outcome measures

Outcome measures
Measure	MSL-109 n=104 Participants The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg. MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.	Placebo n=105 Participants Placebo administered intravenous infusion every 2 weeks 60 mg. MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
Mortality Rate	0.68 deaths per person-year	0.31 deaths per person-year

Adverse Events

MSL-109

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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 University

Phone: 410-955-8198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER