Status:
COMPLETED
Long-Term Assessment for Metabolic, Cardiovascular and Neurologic Problems in HIV-Infected Patients With Increased CD4 Cells Counts Following Anti-HIV Therapy
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Mycobacterium Avium-intracellulare Infection
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
NA
Brief Summary
The purpose of this study is to see if there are any changes in sugar and fat levels in the blood when patients take anti-HIV therapy for many years. Another goal is to test memory and mental concentr...
Detailed Description
The currently available data on clinical events in patients receiving potent antiretroviral therapy suggest that an alteration in the presentation of MAC disease may be seen and that rates of MAC dise...
Eligibility Criteria
Inclusion Criteria
Patients may be eligible for this study if they:
- Are HIV-positive.
- Are at least 13 years old (need consent of parent or guardian if under 18).
- Have had an increase in CD4 cell count from less than or equal to 50 cells/mm3 to over 100 cells/mm3 on 2 separate occasions, at least 4 weeks apart. (This reflects a change in the CD4 cell count requirement.)
- Are on anti-HIV therapy.
- Are currently enrolled in Version 4.0 of the study.
- (This study has been changed to include the enrollment of patients into Version 4.0 of the study.)
Exclusion Criteria
Patients will not be eligible for this study if they:
- Are allergic to azithromycin.
- Have had MAC disease.
- Have a history of tuberculosis (unless successfully treated and off anti-tuberculosis drugs for over 6 months) or other mycobacterial infection requiring chemotherapy.
- Have taken interleukin-2 (IL-2) in the past. (This study has been changed. Patients can now take IL-2 during the study.)
- Are taking certain medications.
Key Trial Info
Start Date :
October 1 1997
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
636 Patients enrolled
Trial Details
Trial ID
NCT00000883
Start Date
October 1 1997
End Date
April 1 2007
Last Update
October 25 2012
Active Locations (51)
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1
Univ of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, United States, 900331079
3
Willow Clinic
Menlo Park, California, United States, 94025
4
Univ of California / San Diego Treatment Ctr
San Diego, California, United States, 921036325