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

Completed · Not applicable

Conditions studied: Mycobacterium Avium-intracellulare Infection, HIV Infections

In brief

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 concentrations to determine if anti-HIV drugs protect the brain from damage caused by HIV. (The purpose of this study has been changed from the original version.) HIV-infected patients with low CD4 cell counts are at risk for getting opportunistic (AIDS-related) infections. CD4 cells are cells of the immune system that help fight infection. Anti-HIV therapy may increase CD4 counts, which may lead to a decrease in AIDS-related infections. Problems that anti-HIV therapy is associated with include metabolic problems, neurologic problems, abnormal opportunistic infections, and cancer. Patients in ACTG 362 have been exposed to anti-HIV therapy longer than any other large group in the ACTG. These patients appear to benefit from their therapy, but also suffer problems from it. Observation of these patients should provide more information about long-term anti-HIV treatment and may detect unexpected problems. (This study as been changed. More information about the reasons for conducting this study has been added.)

Key facts

Study ID

NCT00000883

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

636

Starts

1997-10-01

Expected to finish

2007-04-01

Last updated by the study team

2012-10-25

Who can join

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

You may qualify if…

• 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.)

You may not qualify if…

• 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.

Where it is running

• Univ of Southern California / LA County USC Med 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 Gen Hosp — San Francisco, California, United States
• Stanford at Kaiser / Kaiser Permanente Med Ctr — 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
• Harbor UCLA Med Ctr — Torrance, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Howard Univ — Washington D.C., District of Columbia, United States
• Emory Univ — Atlanta, Georgia, United States
• Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr — Atlanta, Georgia, United States
• Queens Med Ctr — Honolulu, Hawaii, United States
• Univ of Hawaii — Honolulu, Hawaii, United States
• Northwestern Univ Med School — Chicago, Illinois, United States
• Cook County Hosp — Chicago, Illinois, United States
• Rush Presbyterian - Saint Luke's Med Ctr — Chicago, Illinois, United States
• Louis A Weiss Memorial Hosp — Chicago, Illinois, United States
• Indiana Univ Hosp — Indianapolis, Indiana, United States
• Division of Inf Diseases/ Indiana Univ Hosp — Indianapolis, Indiana, United States
• Methodist Hosp of Indiana / Life Care Clinic — Indianapolis, Indiana, United States
• Charity Hosp / Tulane Univ Med School — New Orleans, Louisiana, United States
• Johns Hopkins Hosp — Baltimore, Maryland, United States
• Univ of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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