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

NCT00000883 | Completed

• 1 other identifier: ACTG 362
• Study Type: interventional
• Target: 636
• Locations: 1 country
• Sites: 51

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 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.)

Conditions

Mycobacterium Avium-intracellulare Infection; HIV Infections

Keywords

AIDS-Related Opportunistic Infections; Mycobacterium avium-intracellulare Infection; Antibiotics, Macrolide; Acquired Immunodeficiency Syndrome; Azithromycin; CD4 Lymphocyte Count; Anti-HIV Agents

Interventions

Azithromycin DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (51)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, 900331079, United States

Location

Willow Clinic

Menlo Park, California, 94025, United States

Location

Univ of California / San Diego Treatment Ctr

San Diego, California, 921036325, United States

Location

San Francisco Gen Hosp

San Francisco, California, 941102859, United States

Location

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, 94115, United States

Location

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, California, 951282699, United States

Location

San Mateo AIDS Program / Stanford Univ

Stanford, California, 943055107, United States

Location

Stanford Univ Med Ctr

Stanford, California, 943055107, United States

Location

Harbor UCLA Med Ctr

Torrance, California, 90502, United States

Location

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Howard Univ

Washington D.C., District of Columbia, 20059, United States

Location

Emory Univ

Atlanta, Georgia, 30308, United States

Location

Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr

Atlanta, Georgia, 303652225, United States

Location

Queens Med Ctr

Honolulu, Hawaii, 96816, United States

Location

Univ of Hawaii

Honolulu, Hawaii, 96816, United States

Location

Northwestern Univ Med School

Chicago, Illinois, 60611, United States

Location

Cook County Hosp

Chicago, Illinois, 60612, United States

Location

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, 60612, United States

Location

Louis A Weiss Memorial Hosp

Chicago, Illinois, 60640, United States

Location

Indiana Univ Hosp

Indianapolis, Indiana, 462025250, United States

Location

Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, Indiana, 46202, United States

Location

Methodist Hosp of Indiana / Life Care Clinic

Indianapolis, Indiana, 46202, United States

Location

Charity Hosp / Tulane Univ Med School

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins Hosp

Baltimore, Maryland, 21287, United States

Location

Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, 02114, United States

Location

Boston Med Ctr

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess - West Campus

Boston, Massachusetts, 02215, United States

Location

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, 02215, United States

Location

Univ of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, 63112, United States

Location

Univ of Nebraska Med Ctr

Omaha, Nebraska, 681985130, United States

Location

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, 14215, United States

Location

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

Bellevue Hosp / New York Univ Med Ctr

New York, New York, 10016, United States

Location

Cornell Univ Med Ctr

New York, New York, 10021, United States

Location

Mem Sloan - Kettering Cancer Ctr

New York, New York, 10021, United States

Location

Mount Sinai Med Ctr

New York, New York, 10029, United States

Location

Community Health Network Inc

Rochester, New York, 14642, United States

Location

Univ of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Univ of North Carolina

Chapel Hill, North Carolina, 275997215, United States

Location

Duke Univ Med Ctr

Durham, North Carolina, 27710, United States

Location

Univ of Cincinnati

Cincinnati, Ohio, 452670405, United States

Location

Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Ohio State Univ Hosp Clinic

Columbus, Ohio, 432101228, United States

Location

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Univ of Pittsburgh Med Ctr

Pittsburgh, Pennsylvania, 15213, United States

Location

Julio Arroyo

West Columbia, South Carolina, 29169, United States

Location

Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr

Knoxville, Tennessee, 37920, United States

Location

Univ of Texas Galveston

Galveston, Texas, 775550435, United States

Location

Univ of Washington

Seattle, Washington, 981224304, United States

Location

Related Publications (5)

• von Reyn CF, Williams P, Becker S, Nevin T, Lederman H, Currier J. Skin test reactivity to mycobacterium avium sensitin among patients in ACTG 362. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:151 (abstract no 443)

  BACKGROUND

• Cohn SE, Kammann E, Williams P, Chesney MA, Currier J. Predictors of adherence to azithromycin prophylaxis for prevention of mycobacterium avium complex (MAC) disease. Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:151 (abstract no 444)

  BACKGROUND

• Lederman HM, von Reyn CF, Becker S, Williams P, Currier J. Improved immunologic function correlates with CD4 rise after highly active anti-retroviral therapy (HAART). Conf Retroviruses Opportunistic Infect. 1999 Jan 31-Feb 4;6th:129 (abstract no 326)

  BACKGROUND

• Currier JS, Williams PL, Koletar SL, Cohn SE, Murphy RL, Heald AE, Hafner R, Bassily EL, Lederman HM, Knirsch C, Benson CA, Valdez H, Aberg JA, McCutchan JA. Discontinuation of Mycobacterium avium complex prophylaxis in patients with antiretroviral therapy-induced increases in CD4+ cell count. A randomized, double-blind, placebo-controlled trial. AIDS Clinical Trials Group 362 Study Team. Ann Intern Med. 2000 Oct 3;133(7):493-503. doi: 10.7326/0003-4819-133-7-200010030-00008.

  PMID: 11015162 BACKGROUND

• Cohn SE, Jiang H, McCutchan JA, Koletar SL, Murphy RL, Robertson KR, de St Maurice AM, Currier JS, Williams PL. Association of ongoing drug and alcohol use with non-adherence to antiretroviral therapy and higher risk of AIDS and death: results from ACTG 362. AIDS Care. 2011 Jun;23(6):775-85. doi: 10.1080/09540121.2010.525617.

  PMID: 21293986 RESULT

MeSH Terms

Conditions

Mycobacterium avium-intracellulare Infection; HIV Infections; AIDS-Related Opportunistic Infections; Acquired Immunodeficiency Syndrome

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Opportunistic Infections; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Judith Currier

  STUDY CHAIR

• Allen McCutchan

  STUDY CHAIR

• Susan Koletar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Start: October 1, 1997
• Study Completion: April 1, 2007
• Last Updated: October 25, 2012

Record last verified: 2012-10

Locations

US (51)