Completed

Phase Not Applicable
Age: 13Years +
All Genders
ID00000883

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

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2012-10-25

636

Participants Needed

51

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 13Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

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.
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

Trial Site Locations

Total: 51 locations

1

Univ of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Status Unknown

2

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States, 900331079

Status Unknown

3

Willow Clinic

Menlo Park, California, United States, 94025

Status Unknown

4

Univ of California / San Diego Treatment Ctr

San Diego, California, United States, 921036325

Status Unknown

5

San Francisco Gen Hosp

San Francisco, California, United States, 941102859

Status Unknown

6

Stanford at Kaiser / Kaiser Permanente Med Ctr

San Francisco, California, United States, 94115

Status Unknown

7

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, California, United States, 951282699

Status Unknown

8

San Mateo AIDS Program / Stanford Univ

Stanford, California, United States, 943055107

Status Unknown

9

Stanford Univ Med Ctr

Stanford, California, United States, 943055107

Status Unknown

10

Harbor UCLA Med Ctr

Torrance, California, United States, 90502

Status Unknown

11

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States, 80262

Status Unknown

12

Howard Univ

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

Status Unknown

13

Emory Univ

Atlanta, Georgia, United States, 30308

Status Unknown

14

Emory Hemo Comp Evaluation Clinic / East TN Comp Hemo Ctr

Atlanta, Georgia, United States, 303652225

Status Unknown

15

Queens Med Ctr

Honolulu, Hawaii, United States, 96816

Status Unknown

16

Univ of Hawaii

Honolulu, Hawaii, United States, 96816

Status Unknown

17

Northwestern Univ Med School

Chicago, Illinois, United States, 60611

Status Unknown

18

Cook County Hosp

Chicago, Illinois, United States, 60612

Status Unknown

19

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States, 60612

Status Unknown

20

Louis A Weiss Memorial Hosp

Chicago, Illinois, United States, 60640

Status Unknown

21

Indiana Univ Hosp

Indianapolis, Indiana, United States, 462025250

Status Unknown

22

Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, Indiana, United States, 46202

Status Unknown

23

Methodist Hosp of Indiana / Life Care Clinic

Indianapolis, Indiana, United States, 46202

Status Unknown

24

Charity Hosp / Tulane Univ Med School

New Orleans, Louisiana, United States, 70112

Status Unknown

25

Johns Hopkins Hosp

Baltimore, Maryland, United States, 21287

Status Unknown

26

Harvard (Massachusetts Gen Hosp)

Boston, Massachusetts, United States, 02114

Status Unknown

27

Boston Med Ctr

Boston, Massachusetts, United States, 02118

Status Unknown

28

Beth Israel Deaconess - West Campus

Boston, Massachusetts, United States, 02215

Status Unknown

29

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, United States, 02215

Status Unknown

30

Univ of Minnesota

Minneapolis, Minnesota, United States, 55455

Status Unknown

31

St Louis Regional Hosp / St Louis Regional Med Ctr

St Louis, Missouri, United States, 63112

Status Unknown

32

Univ of Nebraska Med Ctr

Omaha, Nebraska, United States, 681985130

Status Unknown

33

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, United States, 14215

Status Unknown

34

Beth Israel Med Ctr

New York, New York, United States, 10003

Status Unknown

35

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States, 10016

Status Unknown

36

Cornell Univ Med Ctr

New York, New York, United States, 10021

Status Unknown

37

Mem Sloan - Kettering Cancer Ctr

New York, New York, United States, 10021

Status Unknown

38

Mount Sinai Med Ctr

New York, New York, United States, 10029

Status Unknown

39

Community Health Network Inc

Rochester, New York, United States, 14642

Status Unknown

40

Univ of Rochester Medical Center

Rochester, New York, United States, 14642

Status Unknown

41

Univ of North Carolina

Chapel Hill, North Carolina, United States, 275997215

Status Unknown

42

Duke Univ Med Ctr

Durham, North Carolina, United States, 27710

Status Unknown

43

Univ of Cincinnati

Cincinnati, Ohio, United States, 452670405

Status Unknown

44

Case Western Reserve Univ

Cleveland, Ohio, United States, 44106

Status Unknown

45

Ohio State Univ Hosp Clinic

Columbus, Ohio, United States, 432101228

Status Unknown

46

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

47

Univ of Pittsburgh Med Ctr

Pittsburgh, Pennsylvania, United States, 15213

Status Unknown

48

Julio Arroyo

West Columbia, South Carolina, United States, 29169

Status Unknown

49

Univ of Tennessee / E Tennessee Comprehensive Hemophilia Ctr

Knoxville, Tennessee, United States, 37920

Status Unknown

50

Univ of Texas Galveston

Galveston, Texas, United States, 775550435

Status Unknown

51

Univ of Washington

Seattle, Washington, United States, 981224304

Status Unknown

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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.

J S Currier, P L Williams, S L Koletar...

https://pubmed.ncbi.nlm.nih.gov/11015162

Association of ongoing drug and alcohol use with non-adherence to antiretroviral therapy and higher risk of AIDS and death: results from ACTG 362.

Susan E Cohn, Hongyu Jiang, J Allen McCutchan...

https://pubmed.ncbi.nlm.nih.gov/21293986