Status:
COMPLETED
A Study to Evaluate the Effects of Stopping Maintenance Therapy for Cytomegalovirus (CMV) Retinitis After Effective Anti-HIV Therapy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Cytomegalovirus Retinitis
HIV Infections
Eligibility:
All Genders
13+ years
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 (antiretr...
Detailed Description
This study proposes to assess the hypothesis that, in HIV-infected patients with treated and healed CMV retinitis, an increase in CD4+ T-cells after initiation of potent antiretroviral therapy is eith...
Eligibility Criteria
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.
Key Trial Info
Start Date :
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00000905
Last Update
July 30 2008
Active Locations (25)
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1
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
2
UCLA CARE Ctr
Los Angeles, California, United States, 90095
3
Willow Clinic
Menlo Park, California, United States, 94025
4
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325