A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Effective Anti-HIV Therapy
Discontinuation of Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Immune Reconstitution by Potent Antiretroviral Therapy: Safety, Virology, and Immunology Profiles
1 other identifier
observational
75
1 country
25
Brief Summary
The purpose of this study is to see if it is safe to stop maintenance therapy in HIV-positive patients with treated and healed CMV retinitis (eye disease) who have responded well to anti-HIV (antiretroviral) therapy. The current therapies available to treat CMV retinitis are long-term therapies. However, it may be safe to stop long-term anti-CMV therapy in patients with healed CMV retinitis and stable CD4 counts resulting from taking a combination of at least 2 antiretroviral drugs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJuly 30, 2008
June 1, 2003
November 2, 1999
July 28, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- You may be eligible for this study if you:
- Are HIV-positive.
- Have a CD4 count greater than 100 cells/mm3.
- Have healed CMV retinitis after receiving anti-CMV therapy for at least 8 weeks within 3 months prior to study entry.
- Have taken antiretroviral therapy for at least 8 weeks prior to study entry; combination therapy must include at least 2 of the following: protease inhibitors (PIs), nucleoside reverse transcriptase inhibitors (NRTIs), or non-nucleoside reverse transcriptase inhibitors (NNRTIs).
- Have a life expectancy of at least 6 months.
- Are at least 13 years old (need consent if under 18).
You may not qualify if:
- You will not be eligible for this study if you:
- Have any unstable or severe medical conditions that would keep you from completing the study.
- Require chemotherapy or radiation therapy.
- Have a history of certain eye disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079, United States
UCLA CARE Ctr
Los Angeles, California, 90095, United States
Willow Clinic
Menlo Park, California, 94025, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, 941102859, United States
San Francisco Gen Hosp
San Francisco, California, 941102859, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, 951282699, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, 943055107, United States
Stanford Univ Med Ctr
Stanford, California, 943055107, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
Indiana Univ Hosp
Indianapolis, Indiana, 462025250, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202, United States
Johns Hopkins Hosp
Baltimore, Maryland, 21287, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, 63112, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016, United States
Chelsea Ctr
New York, New York, 10021, United States
Cornell Univ Med Ctr
New York, New York, 10021, United States
Mount Sinai Med Ctr
New York, New York, 10029, United States
Univ of North Carolina
Chapel Hill, North Carolina, 275997215, United States
Univ of Cincinnati
Cincinnati, Ohio, 452670405, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Julio Arroyo
West Columbia, South Carolina, 29169, United States
Univ of Texas Galveston
Galveston, Texas, 775550435, United States
Related Publications (1)
Wohl DA, Kendall MA, Owens S, Holland G, Nokta M, Spector SA, Schrier R, Fiscus S, Davis M, Jacobson MA, Currier JS, Squires K, Alston-Smith B, Andersen J, Freeman WR, Higgins M, Torriani FJ; ACTG 379 Study Team. The safety of discontinuation of maintenance therapy for cytomegalovirus (CMV) retinitis and incidence of immune recovery uveitis following potent antiretroviral therapy. HIV Clin Trials. 2005 May-Jun;6(3):136-46. doi: 10.1310/4J65-4YX1-4ET6-E5KR.
PMID: 16192248RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Torriani F
- STUDY CHAIR
Wohl D
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
July 30, 2008
Record last verified: 2003-06