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NCT00000883

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

Last Updated: 2012-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

Total Enrollment

636 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-10-31

Study Completion Date

2007-04-30

Brief Summary

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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.)

Detailed Description

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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. \[AS PER AMENDMENT 11/16/99: The low rate of MAC in ACTG 362 patients after an average of 1 year of follow-up suggests that prophylaxis specifically for MAC disease with azithromycin is not necessary for patients who have experienced immune reconstitution. Prolonged follow-up will define durability of the antiretroviral response and the experience with opportunistic conditions, neurologic diseases, and survival, especially in those whose CD4 counts drop below 50 cells/mm3. It will also allow assessment of the levels of CD4 cell number at which vulnerability to opportunistic infection recur.\] \[AS PER AMENDMENT 03/18/03: During the extension of ACTG 362, serious complications of HAART have become better defined, including metabolic complications, neurologic problems, atypical opportunistic infections, and malignancies. Patients in ACTG 362 have been exposed to HAART longer than any other large group in the ACTG, and appear to benefit from and suffer complications of their therapy. Continued observation should provide estimates of expected complications and durability of long-term potent antiretroviral treatment, and may detect unanticipated problems.\]

Patients are stratified at baseline for prior use of MAC into 3 groups: no prophylaxis, prior azithromycin prophylaxis, and other MAC prophylaxis. Patients are randomized to receive azithromycin (Arm I) or matching placebo (Arm II) once weekly and are followed every 8 weeks until study closure or for 18 months (72 weeks) after the last patient is enrolled. Patients who develop a drop in CD4 count below 50 cells/mm3 on 2 measurements at least 4 weeks apart are offered open-label azithromycin. \[AS PER AMENDMENT 06/24/98: Patients remain on open-label azithromycin regardless of subsequent CD4 counts.\] \[AS PER AMENDMENT 11/16/99: The phase of Version 1.0 or Version 2.0 in which patients receive blinded-study medication is now referred to as Step I. The phase of Version 1.0 or Version 2.0 in which patients receive open-label azithromycin is now referred to as Step 2. Patients not currently on open-label azithromycin provided by the study enter Step 3 and discontinue study drugs, but remain blinded to the original treatment and are followed at 16-week intervals until study closure which will occur in April 2002 (3 years following enrollment of the last study participant). Any patient who develops a drop in CD4 count below 50 cells/mm3 on 2 measurements at least 4 weeks apart is offered open-label azithromycin. Patients currently receiving open-label azithromycin and patients from Step 3 who are initiating open-label azithromycin enter Step 4.\] Patients undergo regular clinical and laboratory evaluations that include physical examinations, CD4 counts, and viral load. \[AS PER AMENDMENT 11/16/99: Patients undergo clinical and laboratory evaluations every 16 weeks for 160 weeks that include physical examinations, CD4 counts, and viral load as well as neuropsychologic and cardiovascular assessments.\] \[AS PER AMENDMENT 01/18/01: All patients enrolled in the study are followed until April 2002.\] \[AS PER AMENDMENT 03/18/02: All patients currently participating in ACTG 362 are invited to continue follow up for an additional 5 years. Patients not currently receiving open-label azithromycin enter Step 5. Patients currently receiving open-label azithromycin enter Step 6, and continue to receive open-label treatment throughout the study. Any patient who enters on Step 5 and develops a drop in CD4 below 50 cells/mm3 on 2 consecutive measurements at least 4 weeks apart is offered open-label azithromycin and enters Step 6. Patients are assessed for metabolic, cardiovascular, and neurologic complications and are evaluated for opportunistic infections, CD4 counts, and viral load. Study visits occur at 32-week intervals until study closure.\]

Conditions

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Mycobacterium Avium-intracellulare Infection HIV Infections

Keywords

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

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Azithromycin

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Principal Investigators

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Judith Currier

Role: STUDY_CHAIR

Allen McCutchan

Role: STUDY_CHAIR

Susan Koletar

Role: STUDY_CHAIR

Locations

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Univ of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States

Site Status

Willow Clinic

Menlo Park, California, United States

Site Status

Univ of California / San Diego Treatment Ctr

San Diego, California, United States

Site Status

San Francisco Gen Hosp

San Francisco, California, United States

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Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, United States

Site Status

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, California, United States

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San Mateo AIDS Program / Stanford Univ

Stanford, California, United States

Site Status

Stanford Univ Med Ctr

Stanford, California, United States

Site Status

Harbor UCLA Med Ctr

Torrance, California, United States

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Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

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Howard Univ

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

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Emory Univ

Atlanta, Georgia, United States

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Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr

Atlanta, Georgia, United States

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Queens Med Ctr

Honolulu, Hawaii, United States

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Univ of Hawaii

Honolulu, Hawaii, United States

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Northwestern Univ Med School

Chicago, Illinois, United States

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Cook County Hosp

Chicago, Illinois, United States

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Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States

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Louis A Weiss Memorial Hosp

Chicago, Illinois, United States

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Indiana Univ Hosp

Indianapolis, Indiana, United States

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Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, Indiana, United States

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Methodist Hosp of Indiana / Life Care Clinic

Indianapolis, Indiana, United States

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Charity Hosp / Tulane Univ Med School

New Orleans, Louisiana, United States

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Johns Hopkins Hosp

Baltimore, Maryland, United States

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Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, United States

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Boston Med Ctr

Boston, Massachusetts, United States

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Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States

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Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States

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Univ of Minnesota

Minneapolis, Minnesota, United States

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St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, United States

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Univ of Nebraska Med Ctr

Omaha, Nebraska, United States

Site Status