A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Effective Anti-HIV Therapy
NCT ID: NCT00000905
Last Updated: 2008-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
75 participants
OBSERVATIONAL
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
In this study, 100 patients \[AS PER AMENDMENT 7/2/99: 50 patients\] with treated and healed, non-immediate sight-threatening CMV retinitis will discontinue maintenance therapy for suppression of CMV retinitis. Patients are studied in 2 groups. Patients enrolled in Group 1 have CD4+ counts greater than 100 cells/mm3. Group 2 patients have CD4+ counts of 50-100 cells/mm3 and a minimum of a 2 log10 decrease in plasma HIV-1 RNA level or plasma HIV-1 RNA levels below the limit of detection while receiving potent antiretroviral therapy for at least 8 weeks prior to entry \[AS PER AMENDMENT 7/2/99: Group 2 has been withdrawn\]. An additional 25 patients who meet eligibility requirements but who choose to continue to receive maintenance therapy may also participate. All patients are followed to evaluate the relationship between reactivation or progression of CMV disease and changes in CMV DNA, HIV-1 RNA, and CD4+ cell counts. Patients are seen at Weeks 2, 4, 6 and 8, and every 4 weeks until study closure or for 12 months after the last subject is enrolled. \[AS PER AMENDMENT 12/24/98: Patients with confirmed moderate to severe "immune recovery vitritis" should receive a 3-week course of systemic steroids (oral prednisone recommended). Moderate immune recovery vitritis is defined as symptomatic decrease in visual acuity of 2 or more Snellen lines along with, in the absence of active CMV disease, either 2+ or greater vitreous haze as defined by Nussenblatt et al., or cystoid macular edema.\] \[AS PER AMENDMENT 7/2/99: During the course of the study in patients with confirmed cystoid macular edema and a concomitant reduction in visual activity below 20/40, both attributable to immune recovery vitritis/uveitis only, a 21-day course of oral prednisone is recommended. This initial course of steroids helps to determine whether there is an improvement in vision or a decrease in macular edema. Long-term management of immune recovery vitritis/uveitis may include intraocular injection of steroids. Ophthalmoscopic examinations and laboratory tests are performed as per protocol.\]
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Torriani F
Role: STUDY_CHAIR
Wohl D
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States
UCLA CARE Ctr
Los Angeles, California, United States
Willow Clinic
Menlo Park, California, United States
Univ of California / San Diego Treatment Ctr
San Diego, California, United States
San Francisco AIDS Clinic / San Francisco Gen Hosp
San Francisco, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium
San Jose, California, United States
San Mateo AIDS Program / Stanford Univ
Stanford, California, United States
Stanford Univ Med Ctr
Stanford, California, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Indiana Univ Hosp
Indianapolis, Indiana, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States
Johns Hopkins Hosp
Baltimore, Maryland, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Chelsea Ctr
New York, New York, United States
Cornell Univ Med Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Univ of North Carolina
Chapel Hill, North Carolina, United States
Univ of Cincinnati
Cincinnati, Ohio, United States
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, United States
Julio Arroyo
West Columbia, South Carolina, United States
Univ of Texas Galveston
Galveston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ACTG 379
Identifier Type: -
Identifier Source: org_study_id