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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID) (NIH)

Overall Status

Completed

CT.gov ID

NCT00000947

Collaborator

(none)

850

Enrollment

Locations

44.7

Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Mycobacterium Avium-intracellulare Infection HIV Infections	Drug: Azithromycin	N/A

Detailed Description

The need for MAC prophylaxis in advanced HIV disease is recognized. Prophylactic therapy is complicated, however, due to drug toxicity, potential drug interactions, patient noncompliance with multiagent regimens, microbial drug resistance, and high treatment costs. This study assesses the feasibility of deferring MAC prophylaxis in patients whose CD4+ cell counts rebound in response to antiretroviral therapy.

In this double-blind, placebo-controlled trial, patients are randomized to receive azithromycin weekly or matching placebo. Patients are switched to open-label azithromycin if they have an average CD4+ cell count less than 50 cells/mm3 on 2 consecutive counts obtained at least 48 hours apart (preferably no more than 60 days).

[AS PER AMENDMENT 10/23/97: SUBSTUDY CPCRA 054: A subset of participants of CPCRA 048 have oropharyngeal swabs taken at baseline and 4 months after randomization. Antibiotic susceptibility tests are then performed on isolates of S. pneumoniae.] [AS PER AMENDMENT 9/3/99: Participants in protocol version 3.0 are followed for data collection purposes every 4 months for 18 months until January 31, 2001. Data collection includes CD4 cell counts, viral RNA measurements, macrolide susceptibility in MAC isolates, and antibiotic susceptibility of isolates from bacterial pneumonia episodes.]

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

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

Actual Study Completion Date :

Jul 1, 2000

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Community Consortium / Jon Kaiser Wellness Ctr	San Francisco	California	United States	94110
2	Community Consortium / UCSF	San Francisco	California	United States	94110
3	Denver CPCRA / Denver Public Hlth	Denver	Colorado	United States	80204
4	Washington Reg AIDS Prog / Dept of Infect Dis	Washington	District of Columbia	United States	20422
5	AIDS Research Consortium of Atlanta	Atlanta	Georgia	United States	30308
6	AIDS Research Alliance - Chicago	Chicago	Illinois	United States	60657
7	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana	United States	70112
8	LSMUC / Lions Clinic	New Orleans	Louisiana	United States	70112
9	Catherine McAuley Health Ctr	Detroit	Michigan	United States	48201
10	Wayne State Univ - WSU/DMC / Univ Hlth Ctr	Detroit	Michigan	United States	48201
11	Henry Ford Hosp	Detroit	Michigan	United States	48202
12	Southern New Jersey AIDS Cln Trials / Dept of Med	Camden	New Jersey	United States	08103
13	North Jersey Community Research Initiative	Newark	New Jersey	United States	07103
14	Partners in Research / New Mexico	Albuquerque	New Mexico	United States	87131
15	Harlem AIDS Treatment Grp / Harlem Hosp Ctr	New York	New York	United States	10037
16	The Research and Education Group	Portland	Oregon	United States	97210
17	Philadelphia FIGHT	Philadelphia	Pennsylvania	United States	19107
18	Saint Joseph's Hosp	Philadelphia	Pennsylvania	United States	19107
19	Richmond AIDS Consortium / Div of Infect Diseases	Richmond	Virginia	United States	23298