Search / Trial NCT00000143

Studies of Ocular Complications of AIDS (SOCA)--Ganciclovir-Cidofovir CMV Retinitis Trial (GCCRT)

Launched by JOHNS HOPKINS BLOOMBERG SCHOOL OF PUBLIC HEALTH · Sep 23, 1999

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Description

Cytomegalovirus (CMV) is among the most frequently encountered opportunistic infections in patients with AIDS. In the era of prophylaxis for pneumocystic pneumonia, CMV disease is estimated to affect 45 percent of patients with AIDS sometime between the diagnosis of AIDS and death. Retinitis has been estimated to account for up to 85 percent of CMV disease in these patients, making CMV retinitis the most common ocular infection encountered. CMV retinitis is a relatively late-stage manifestation, associated with cluster of differentiation 4 (CD4) + T-cell counts < 100 cells/µL and often < 50...

Gender

All

Eligibility criteria

  • Inclusion criteria:
  • Age 13 years or older
  • Diagnosis of AIDS according to current Centers for Disease Control and Prevention (CDC) definition
  • Diagnosis of active CMV retinitis by a SOCA-certified ophthalmologist (involvement of any zone or amount of retina is allowed)
  • Best corrected visual acuity of 20/100 or better in at least one eye
  • At least one lesion 750 cells/µL or greater
  • Platelet count 50,000 cells/µL or greater
  • Willingness and ability, with the assistance of a caregiver if necessary to comply with treatment and follow up procedures
  • Willingness of all men and women of childbearing potential to practice adequate birth control to prevent pregnancies during the study and for 3 months afterwards
  • Collection of all baseline data within 5 days prior to randomization
  • Signed consent statement
  • Exclusion criteria:
  • Media opacities that preclude visualization of the fundus of all otherwise eligible eyes
  • Treatment for CMV retinitis with the ganciclovir intraocular implant within 9 months of study entry
  • Medical problems or drug or alcohol abuse sufficient to hinder adherence to treatment or follow up procedures
  • Unwillingness to refrain from breast-feeding during the study and for 3 months afterwards

Attachments

readout_NCT00000143_2024-05-23.pdf

4.5 MB

NCT00000143_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Houston, Texas, United States

Irvine, California, United States

La Jolla, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

San Francisco, California, United States

Miami, Florida, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

New Orleans, Louisiana, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Newark, New Jersey, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

3 years

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
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Leslie Alexander
20 September 2023

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Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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