ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00000135
Recruitment Status : Completed
First Posted : September 24, 1999
Results First Posted : November 17, 2015
Last Update Posted : November 17, 2015
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions HIV Infections
Cytomegalovirus Retinitis
Interventions Drug: MSL-109
Other: Placebo
Enrollment 209

Recruitment Details 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.
Pre-assignment Details 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,.
Arm/Group Title MSL-109 Placebo
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 104 105
Completed 77 91
Not Completed 27 14
Reason Not Completed
Death             27             14
Arm/Group Title MSL-109 Placebo Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 104 105 209
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 105 participants 209 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
104
 100.0%
105
 100.0%
209
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 105 participants 209 participants
Female
11
  10.6%
11
  10.5%
22
  10.5%
Male
93
  89.4%
94
  89.5%
187
  89.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 104 participants 105 participants 209 participants
104 105 209
1.Primary Outcome
Title Mortality Rate
Hide Description to evaluate the efficacy of an intravenous human monoclonal antibody to cytomegalovirus (CMV), MSL-109, as adjuvant treatment for CMV retinitis. .
Time Frame All patients enrolled were followed for a 17 month period or until a common study closing date
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title MSL-109 Placebo
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 104 105
Measure Type: Number
Unit of Measure: deaths per person-year
0.68 0.31
Time Frame 11 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MSL-109 Placebo
Hide Arm/Group Description

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 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.

All-Cause Mortality
MSL-109 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MSL-109 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/104 (0.00%)   0/105 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
MSL-109 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/104 (0.00%)   0/105 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Curtis Meinert, PhD
Organization: Johns Hopkins University
Phone: 410-955-8198
Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00000135     History of Changes
Other Study ID Numbers: NEI-34
First Submitted: September 23, 1999
First Posted: September 24, 1999
Results First Submitted: June 12, 2015
Results First Posted: November 17, 2015
Last Update Posted: November 17, 2015