A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Effective Anti-HIV Therapy

Completed

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

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.

Key facts

Study ID

NCT00000905

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

75

Last updated by the study team

2008-07-30

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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