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Long-Term Assessment for Metabolic, Cardiovascular and Neurologic Complications In Subjects With Past CD4 Cells/mm3 Below 50 Who Increased CD4 Cells/mm3 to Above 100 on HAART


N/A
13 Years
N/A
Not Enrolling
Both
Mycobacterium Avium-intracellulare Infection, HIV Infections

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Trial Information

Long-Term Assessment for Metabolic, Cardiovascular and Neurologic Complications In Subjects With Past CD4 Cells/mm3 Below 50 Who Increased CD4 Cells/mm3 to Above 100 on HAART


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.]

Inclusion 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.

Type of Study:

Interventional

Study Design:

Masking: Double-Blind, Primary Purpose: Treatment

Principal Investigator

Judith Currier

Investigator Role:

Study Chair

Authority:

United States: Federal Government

Study ID:

ACTG 362

NCT ID:

NCT00000883

Start Date:

October 1997

Completion Date:

April 2007

Related Keywords:

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

Name

Location

San Francisco Gen Hosp San Francisco, California  941102859
Bellevue Hosp / New York Univ Med Ctr New York, New York  10016
Mem Sloan - Kettering Cancer Ctr New York, New York  10021
Univ of Rochester Medical Center Rochester, New York  14642
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Stanford at Kaiser / Kaiser Permanente Med Ctr San Francisco, California  94115
Harbor UCLA Med Ctr Torrance, California  90502
Univ of Colorado Health Sciences Ctr Denver, Colorado  80262
Rush Presbyterian - Saint Luke's Med Ctr Chicago, Illinois  60612
Northwestern Univ Med School Chicago, Illinois  60611
Indiana Univ Hosp Indianapolis, Indiana  462025250
Harvard (Massachusetts Gen Hosp) Boston, Massachusetts  02114
Beth Israel Deaconess Med Ctr Boston, Massachusetts  02215
Beth Israel Deaconess - West Campus Boston, Massachusetts  02215
Boston Med Ctr Boston, Massachusetts  02118
Univ of Minnesota Minneapolis, Minnesota  55455
SUNY / Erie County Med Ctr at Buffalo Buffalo, New York  14215
Cornell Univ Med Ctr New York, New York  10021
Mount Sinai Med Ctr New York, New York  10029
Univ of North Carolina Chapel Hill, North Carolina  275997215
Duke Univ Med Ctr Durham, North Carolina  27710
Ohio State Univ Hosp Clinic Columbus, Ohio  432101228
Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr Knoxville, Tennessee  37920
Univ of Washington Seattle, Washington  98105
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Charity Hosp / Tulane Univ Med School New Orleans, Louisiana  70112
St Louis Regional Hosp / St Louis Regional Med Ctr St Louis, Missouri  63112
Univ of Alabama at Birmingham Birmingham, Alabama  35294
Univ of Southern California / LA County USC Med Ctr Los Angeles, California  900331079
Cook County Hosp Chicago, Illinois  60612
Univ of Nebraska Med Ctr Omaha, Nebraska  681985130
Beth Israel Med Ctr New York, New York  10003
Univ of Cincinnati Cincinnati, Ohio  452670405
Univ of Pennsylvania at Philadelphia Philadelphia, Pennsylvania  19104
Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium San Jose, California  951282699
Stanford Univ Med Ctr Stanford, California  943055107
San Mateo AIDS Program / Stanford Univ Stanford, California  943055107
Howard Univ Washington, District of Columbia  20059
Univ of Hawaii Honolulu, Hawaii  96816
Louis A Weiss Memorial Hosp Chicago, Illinois  60640
Methodist Hosp of Indiana / Life Care Clinic Indianapolis, Indiana  46202
Case Western Reserve Univ Cleveland, Ohio  44106
Univ of Texas Galveston Galveston, Texas  775550435
Queens Med Ctr Honolulu, Hawaii  96816
Emory Univ Atlanta, Georgia  30308
Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr Atlanta, Georgia  303652225
Division of Inf Diseases/ Indiana Univ Hosp Indianapolis, Indiana  46202
Willow Clinic Menlo Park, California  94025
Community Health Network Inc Rochester, New York  14642
Univ of Pittsburgh Med Ctr Pittsburgh, Pennsylvania  15213