Completed

Phase Not Applicable
Age: 13Years +
All Genders
ID00000947

A Randomized, Double-Blind, Placebo-Controlled Trial of Prophylaxis for Disseminated Mycobacterium Avium Complex Disease and Bacterial Pneumonia Versus Deferred Prophylaxis in HIV-Infected Patients Who Experience Rebound in CD4+ Cell Count Due to Active Antiretroviral Therapy

Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2021-11-03

850

Participants Needed

19

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is designed to find out whether HIV-positive patients whose immune systems have improved after receiving anti-HIV treatment should take azithromycin to prevent Mycobacterium avium complex (MAC) disease. This study also examines the possibility of putting off MAC prevention treatment in patients who respond well to anti-HIV drug therapy. Azithromycin is approved for the prevention of MAC disease in people with HIV and low CD4 cell counts. However, some people who have taken azithromycin have been found to carry antibiotic-resistant bacteria (germs that can grow despite the presence of drugs used to kill them). It is not known whether the risks associated with taking azithromycin outweigh the risk of getting MAC disease.

CONDITIONS

Official Title

A Study to Evaluate the Effects of Azithromycin on MAC Disease Prevention in HIV-Positive Patients

Who Can Participate

Age: 13Years +
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 2 CD4 counts over 100 cells/mm3 at least 30 days apart.
  • Have a history of CD4 counts under 50 cells/mm3.
  • Are at least 13 years old (need consent if under 18).
  • Are in reasonably good health.
  • Are expected to live for at least 6 months.
  • Are receiving anti-HIV medications at study entry.

Exclusion Criteria

You will not be eligible for this study if you:

  • Have/had MAC disease.
  • Have been unable to take azithromycin in the past.
  • Are on any medications that act against MAC.
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: 19 locations

1

Community Consortium / Jon Kaiser Wellness Ctr

San Francisco, California, United States, 94110

Status Unknown

2

Community Consortium / UCSF

San Francisco, California, United States, 94110

Status Unknown

3

Denver CPCRA / Denver Public Hlth

Denver, Colorado, United States, 80204

Status Unknown

4

Washington Reg AIDS Prog / Dept of Infect Dis

Washington D.C., District of Columbia, United States, 20422

Status Unknown

5

AIDS Research Consortium of Atlanta

Atlanta, Georgia, United States, 30308

Status Unknown

6

AIDS Research Alliance - Chicago

Chicago, Illinois, United States, 60657

Status Unknown

7

Louisiana Comm AIDS Rsch Prog / Tulane Univ Med

New Orleans, Louisiana, United States, 70112

Status Unknown

8

LSMUC / Lions Clinic

New Orleans, Louisiana, United States, 70112

Status Unknown

9

Catherine McAuley Health Ctr

Detroit, Michigan, United States, 48201

Status Unknown

10

Wayne State Univ - WSU/DMC / Univ Hlth Ctr

Detroit, Michigan, United States, 48201

Status Unknown

11

Henry Ford Hosp

Detroit, Michigan, United States, 48202

Status Unknown

12

Southern New Jersey AIDS Cln Trials / Dept of Med

Camden, New Jersey, United States, 08103

Status Unknown

13

North Jersey Community Research Initiative

Newark, New Jersey, United States, 07103

Status Unknown

14

Partners in Research / New Mexico

Albuquerque, New Mexico, United States, 87131

Status Unknown

15

Harlem AIDS Treatment Grp / Harlem Hosp Ctr

New York, New York, United States, 10037

Status Unknown

16

The Research and Education Group

Portland, Oregon, United States, 97210

Status Unknown

17

Philadelphia FIGHT

Philadelphia, Pennsylvania, United States, 19107

Status Unknown

18

Saint Joseph's Hosp

Philadelphia, Pennsylvania, United States, 19107

Status Unknown

19

Richmond AIDS Consortium / Div of Infect Diseases

Richmond, Virginia, United States, 23298

Status Unknown

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

N/A

Allocation

N/A

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

0

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Published Research Related To This Trial

Discontinuation of prophylaxis against Mycobacterium avium complex disease in HIV-infected patients who have a response to antiretroviral therapy. Terry Beirn Community Programs for Clinical Research on AIDS.

W M El-Sadr, W J Burman, L B Grant...

https://pubmed.ncbi.nlm.nih.gov/10766581