The safety of discontinuation of maintenance therapy for cytomegalovirus (CMV) retinitis and incidence of immune recovery uveitis following potent antiretroviral therapy.
D A Wohl, M A Kendall, S Owens...
https://pubmed.ncbi.nlm.nih.gov/16192248Completed
Age: 13Years +
All Genders
ID00000905
Discontinuation of Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Immune Reconstitution by Potent Antiretroviral Therapy: Safety, Virology, and Immunology Profiles
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2008-07-30
75
Participants Needed
25
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Effective Anti-HIV Therapy
Who Can Participate
Age: 13Years +
All Genders
Eligibility Criteria
You may qualify if you...
Inclusion Criteria
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).
Exclusion Criteria
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 25 locations
1
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
Status Unknown
2
UCLA CARE Ctr
Los Angeles, California, United States, 90095
Status Unknown
3
Willow Clinic
Menlo Park, California, United States, 94025
Status Unknown
4
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325
Status Unknown
5
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
6
San Francisco Gen Hosp
San Francisco, California, United States, 941102859
Status Unknown
7
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States, 951282699
Status Unknown
8
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States, 943055107
Status Unknown
9
Stanford Univ Med Ctr
Stanford, California, United States, 943055107
Status Unknown
10
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States, 80262
Status Unknown
11
Northwestern Univ Med School
Chicago, Illinois, United States, 60611
Status Unknown
12
Indiana Univ Hosp
Indianapolis, Indiana, United States, 462025250
Status Unknown
13
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States, 46202
Status Unknown
14
Johns Hopkins Hosp
Baltimore, Maryland, United States, 21287
Status Unknown
15
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States, 63112
Status Unknown
16
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States, 14215
Status Unknown
17
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States, 10016
Status Unknown
18
Chelsea Ctr
New York, New York, United States, 10021
Status Unknown
19
Cornell Univ Med Ctr
New York, New York, United States, 10021
Status Unknown
20
Mount Sinai Med Ctr
New York, New York, United States, 10029
Status Unknown
21
Univ of North Carolina
Chapel Hill, North Carolina, United States, 275997215
Status Unknown
22
Univ of Cincinnati
Cincinnati, Ohio, United States, 452670405
Status Unknown
23
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Status Unknown
24
Julio Arroyo
West Columbia, South Carolina, United States, 29169
Status Unknown
25
Univ of Texas Galveston
Galveston, Texas, United States, 775550435
Status Unknown
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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