Long-Term Assessment for Metabolic, Cardiovascular and Neurologic Problems in HIV-Infected Patients With Increased CD4 Cells Counts Following Anti-HIV Therapy

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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 disease may be reduced when patients respond to antiretroviral therapy. However, the extent of the protection and the timing of protection after initiation of therapy remain unknown. The current study should provide validated measures of immune restoration and clinical data to guide prophylaxis decisions for the many patients who are now responding to therapy after years of immune depletion. \[AS P...

Gender

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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.

Trial Officials