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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT00000135
First received: September 23, 1999
Last updated: October 14, 2015
Last verified: July 2015
Results First Received: June 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver);   Primary Purpose: Treatment
Conditions: HIV Infections
Cytomegalovirus Retinitis
Interventions: Drug: MSL-109
Other: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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,.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    MSL-109     Placebo  
STARTED     104     105  
COMPLETED     77     91  
NOT COMPLETED     27     14  
Death                 27                 14  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
    MSL-109     Placebo     Total  
Number of Participants  
[units: participants]
  104     105     209  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     104     105     209  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     11     11     22  
Male     93     94     187  
Region of Enrollment  
[units: participants]
     
United States     104     105     209  



  Outcome Measures

1.  Primary:   Mortality Rate   [ Time Frame: All patients enrolled were followed for a 17 month period or until a common study closing date ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Curtis Meinert, PhD
Organization: Johns Hopkins University
phone: 410-955-8198
e-mail: cmeinert@jhsph.edu


Publications of Results:

Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT00000135     History of Changes
Other Study ID Numbers: NEI-34
Study First Received: September 23, 1999
Results First Received: June 12, 2015
Last Updated: October 14, 2015
Health Authority: United States: Federal Government