Completed

Phase Not Applicable
Age: 18Years +
All Genders
ID00000895

Pathogenesis of MAC Disease in Advanced HIV-1-Infected Subjects and the Impact of Highly-Active Antiretroviral Treatment (HAART) on Immune Functions Relevant for MAC and Other Opportunistic Infections

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-10-29

85

Participants Needed

26

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to determine if infection with Mycobacterium avium complex (MAC) occurs in other parts of the body before it is found in the blood. This study also evaluates the relationships between the amount of HIV in the blood, immune system functions, and the presence of MAC infection. HIV-positive patients are at risk for MAC infection because their immune systems have been weakened by HIV. It is hoped that aggressive treatment with anti-HIV drugs may improve their immune systems enough to prevent against MAC.

CONDITIONS

Official Title

A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients With Advanced HIV Infection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

Inclusion Criteria

You may be eligible for this study if you:

  • Are HIV-positive.
  • Have a CD4 count under 50 cells/mm3 or between 100 and 250 cells/mm3 within 30 days of study entry.
  • Have at least one symptom (e.g., fever, diarrhea, or weight loss) suggestive of MAC infection.
  • Have MAC infection with 7 days or less of MAC treatment.
  • Have an HIV blood level greater than 10,000 copies/ml within 30 days of study entry.
  • Are 18 years of age or older.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have any active infection (except for MAC in Group 2 patients) or any cancer.
  • Are unable to follow an acceptable anti-HIV drug regimen (Groups 2 and 3).
  • Are pregnant or breast-feeding.
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: 26 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

Univ of California / San Diego Treatment Ctr

San Diego, California, United States, 921036325

Status Unknown

4

Stanford Univ Med Ctr

Stanford, California, United States, 943055107

Status Unknown

5

Howard Univ

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

Status Unknown

6

Univ of Miami School of Medicine

Miami, Florida, United States, 331361013

Status Unknown

7

Emory Univ

Atlanta, Georgia, United States, 30308

Status Unknown

8

Northwestern Univ Med School

Chicago, Illinois, United States, 60611

Status Unknown

9

Cook County Hosp

Chicago, Illinois, United States, 60612

Status Unknown

10

Rush Presbyterian - Saint Luke's Med Ctr

Chicago, Illinois, United States, 60612

Status Unknown

11

Indiana Univ Hosp

Indianapolis, Indiana, United States, 462025250

Status Unknown

12

Division of Inf Diseases/ Indiana Univ Hosp

Indianapolis, Indiana, United States, 46202

Status Unknown

13

SUNY / Erie County Med Ctr at Buffalo

Buffalo, New York, United States, 14215

Status Unknown

14

Beth Israel Med Ctr

New York, New York, United States, 10003

Status Unknown

15

Bellevue Hosp / New York Univ Med Ctr

New York, New York, United States, 10016

Status Unknown

16

St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr

New York, New York, United States, 10021

Status Unknown

17

Univ of Rochester Medical Center

Rochester, New York, United States, 14642

Status Unknown

18

Univ of Cincinnati

Cincinnati, Ohio, United States, 452670405

Status Unknown

19

Case Western Reserve Univ

Cleveland, Ohio, United States, 44106

Status Unknown

20

Ohio State Univ Hosp Clinic

Columbus, Ohio, United States, 432101228

Status Unknown

21

Univ of Pennsylvania at Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Status Unknown

22

Julio Arroyo

West Columbia, South Carolina, United States, 29169

Status Unknown

23

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, United States, 75235

Status Unknown

24

Univ of Texas, Southwestern Med Ctr of Dallas

Dallas, Texas, United States, 75390

Status Unknown

25

Univ of Texas Galveston

Galveston, Texas, United States, 775550435

Status Unknown

26

Univ of Washington

Seattle, Washington, United States, 98104

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Clinical, microbiological, and immunological characteristics in HIV-infected subjects at risk for disseminated Mycobacterium avium complex disease: an AACTG study.

Rob Roy MacGregor, Richard Hafner, Julia W Wu...

https://pubmed.ncbi.nlm.nih.gov/16131307
Pathogenesis of MAC Disease in Advanced HIV-1-Infected Subjects and the Impact of Highly-Active Antiretroviral Treatment (HAART) on Immune Functions Relevant for MAC and Other Opportunistic Infections | DecenTrialz