Completed

Age: 13Years +
All Genders
ID00000907

A Study of Discontinuing Maintenance Therapy in Subjects With Disseminated Mycobacterium Avium Complex (DMAC)

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2008-07-30

50

Participants Needed

24

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the effects of stopping preventive therapy for DMAC in HIV-positive patients who (1) have been treated for DMAC for at least 12 months and are now free of any signs of DMAC for at least 16 weeks, and (2) have improved immune systems (CD4 cell counts greater than or equal to 100 cells/mm3) due to anti-HIV drug therapy. DMAC is a serious and sometimes life-threatening infection that usually affects only HIV-positive patients with CD4 cell counts (cells of the immune system that fight infection) less than 50 cells/mm3. It is recommended that people who are likely to get DMAC be placed on preventive medications which help reduce the risk of infection. New anti-HIV combination drug therapies can increase CD4 cell counts and can reduce the level of HIV in the blood. When CD4 counts are increased, risk of DMAC infection is less. This study examines whether it is possible to stop preventive therapy for DMAC when CD4 counts are high without placing individuals at risk for getting DMAC again.

CONDITIONS

Official Title

A Study to Examine the Effects of Stopping Preventive Therapy for Disseminated Mycobacterium Avium Complex (DMAC) in HIV-Positive Patients

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.
  • Have 2 CD4 cell counts greater than or equal to 100 cells/mm3 within 60 days and 14 days prior to entry. Measurements must be taken at least 24 hours apart.
  • Have been treated for DMAC with a drug regimen including at least 2 antimycobacterial drugs for at least 12 months, and have been free of symptoms for at least 16 weeks prior to study entry.
  • Have been on anti-HIV therapy for at least 16 weeks and have been on stable anti-HIV therapy for at least 8 weeks prior to study entry.
  • Are at least 13 years old (need consent of parent or guardian if under 18).

Exclusion Criteria

Patients will not be eligible for this study if they:

  • Have any active infection (unless they have been on stable chronic suppressive therapy for at least 3 months).
  • Are pregnant.
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: 24 locations

1

Univ of Southern California / LA County USC Med Ctr

Los Angeles, California, United States, 900331079

Status Unknown

2

Willow Clinic

Menlo Park, California, United States, 94025

Status Unknown

3

Univ of California / San Diego Treatment Ctr

San Diego, California, United States, 921036325

Status Unknown

4

San Francisco AIDS Clinic / San Francisco Gen Hosp

San Francisco, California, United States, 941102859

Status Unknown

5

San Francisco Gen Hosp

San Francisco, California, United States, 941102859

Status Unknown

6

Santa Clara Valley Med Ctr / AIDS Community Rsch Consortium

San Jose, California, United States, 951282699

Status Unknown

7

San Mateo AIDS Program / Stanford Univ

Stanford, California, United States, 943055107

Status Unknown

8

Stanford Univ Med Ctr

Stanford, California, United States, 943055107

Status Unknown

9

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States, 80262

Status Unknown

10

Univ of Miami School of Medicine

Miami, Florida, United States, 331361013

Status Unknown

11

Emory Univ

Atlanta, Georgia, United States, 30308

Status Unknown

12

Univ of Hawaii

Honolulu, Hawaii, United States, 96816

Status Unknown

13

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States, 60612

Status Unknown

14

Indiana Univ Hosp

Indianapolis, Indiana, United States, 462025250

Status Unknown

15

Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, Indiana, United States, 46202

Status Unknown

16

Johns Hopkins Hosp

Baltimore, Maryland, United States, 21287

Status Unknown

17

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, United States, 14215

Status Unknown

18

Beth Israel Med Ctr

New York, New York, United States, 10003

Status Unknown

19

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States, 10016

Status Unknown

20

Mount Sinai Med Ctr

New York, New York, United States, 10029

Status Unknown

21

Univ of North Carolina

Chapel Hill, North Carolina, United States, 275997215

Status Unknown

22

Univ of Cincinnati

Cincinnati, Ohio, United States, 452670405

Status Unknown

23

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

24

Julio Arroyo

West Columbia, South Carolina, United States, 29169

Status Unknown

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

A study of discontinuing maintenance therapy in human immunodeficiency virus-infected subjects with disseminated Mycobacterium avium complex: AIDS Clinical Trial Group 393 Study Team.

Judith A Aberg, Paige L Williams, Tun Liu...

https://pubmed.ncbi.nlm.nih.gov/12660918