Clinical trialNCT00000883CompletedInterventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment636HIV InfectionsMycobacterium Avium-intracellulare Infection

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.)

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Allen McCutchan
Study Chair
clinicaltrials.gov ↗
Judith Currier
Study ChairKOL profile →
clinicaltrials.gov ↗
Susan Koletar
Study Chair
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

51 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Univ of Alabama at Birmingham
Birmingham, Alabama, United States
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 Hemo Comp Evaluation Clinic / East Tn Comp Hemo Ctr
Atlanta, Georgia, United States
Emory Univ
Atlanta, Georgia, United States
Queens Med Ctr
Honolulu, Hawaii, United States
Univ of Hawaii
Honolulu, Hawaii, United States
Cook County Hosp
Chicago, Illinois, United States
Louis A Weiss Memorial Hosp
Chicago, Illinois, United States
Northwestern Univ Med School
Chicago, Illinois, United States
Rush Presbyterian - Saint Luke'S Med Ctr
Chicago, Illinois, United States
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, United States
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
Beth Israel Deaconess - West Campus
Boston, Massachusetts, United States
Beth Israel Deaconess Med Ctr
Boston, Massachusetts, United States
Boston Med Ctr
Boston, Massachusetts, United States
Harvard (massachusetts Gen Hosp)
Boston, Massachusetts, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
St Louis Regional Hosp / St Louis Regional Med Ctr
St Louis, Missouri, United States
Univ of Nebraska Med Ctr
Omaha, Nebraska, 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
Beth Israel Med Ctr
New York, New York, United States
Cornell Univ Med Ctr
New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
Mount Sinai Med Ctr
New York, New York, United States
Community Health Network Inc
Rochester, New York, United States
Univ of Rochester Medical Center
Rochester, New York, United States

11 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Azithromycin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Oct 1997
Primary completion: —
Completion: 30 Apr 2007
Last update posted: 25 Oct 2012
Registered enrollment: 636
Registry id: NCT00000883

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.