Studies of the Ocular Complications of AIDS (SOCA)--Monoclonal Antibody CMV Retinitis Trial (MACRT)
NCT00000135 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 209
Last updated 2015-11-17
Summary
To evaluate the efficacy and safety of a human anti-CMV monoclonal antibody, MSL-109, as adjunct therapy for controlling CMV retinitis.
Conditions
- HIV Infections
- Cytomegalovirus Retinitis
Interventions
- DRUG
-
MSL-109
60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
- OTHER
-
Placebo
60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout.
Sponsors & Collaborators
-
Johns Hopkins Bloomberg School of Public Health
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 13 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1995-09-30
- Primary Completion
- 1996-08-31
- Completion
- 1996-08-31
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