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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000947
• Other study ID #: CPCRA 048
• Secondary ID: 11600
• Status: Completed
• Phase: N/A
• Est. completion date: July 2000

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 850
• Est. completion date: July 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• HIV Infections
• Infections
• Mycobacterium avium-intracellulare Infection
• Mycobacterium Infections

Intervention

Drug:
• Azithromycin

Locations

Country	Name	City	State
United States	Partners in Research / New Mexico	Albuquerque	New Mexico
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Southern New Jersey AIDS Cln Trials / Dept of Med	Camden	New Jersey
United States	AIDS Research Alliance - Chicago	Chicago	Illinois
United States	Denver CPCRA / Denver Public Hlth	Denver	Colorado
United States	Catherine McAuley Health Ctr	Detroit	Michigan
United States	Henry Ford Hosp	Detroit	Michigan
United States	Wayne State Univ - WSU/DMC / Univ Hlth Ctr	Detroit	Michigan
United States	Louisiana Comm AIDS Rsch Prog / Tulane Univ Med	New Orleans	Louisiana
United States	LSMUC / Lions Clinic	New Orleans	Louisiana
United States	Harlem AIDS Treatment Grp / Harlem Hosp Ctr	New York	New York
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Philadelphia FIGHT	Philadelphia	Pennsylvania
United States	Saint Joseph's Hosp	Philadelphia	Pennsylvania
United States	The Research and Education Group	Portland	Oregon
United States	Richmond AIDS Consortium / Div of Infect Diseases	Richmond	Virginia
United States	Community Consortium / Jon Kaiser Wellness Ctr	San Francisco	California
United States	Community Consortium / UCSF	San Francisco	California
United States	Washington Reg AIDS Prog / Dept of Infect Dis	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Burman W, El-Sadr W, Grant L, Matts J, Zeh D, Gallagher B, Hafner R, Crane L, Gordin F. Low rates of all opportunistic infections among patients with advanced HIV disease responding to antiretroviral therapy - the CPCRA 048 Cohort. 7th Conf Retroviruses Opportunistic Infect. 2000 Jan 30-Feb 2 (abstract no 241)

El-Sadr WM, Burman W, Grant L, Matts JP, Zeh D, Crane L, Gallagher B, Gordin F, Hafner R. Prophylaxis for Mycobacterium avium Complex can be deferred among patients with a past CD4 count <50 cells/mm3 who responded to antiretroviral therapy: results of a placebo-controlled trial (CPCRA 048). 7th Conf Retroviruses Opportunistic Infect. 2000 Jan 30-Feb 2 (abstract no 247)

El-Sadr WM, Burman WJ, Grant LB, Matts JP, Hafner R, Crane L, Zeh D, Gallagher B, Mannheimer SB, Martinez A, Gordin F. 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. N Engl J Med. 2000 Apr 13;342(15):1085-92. — View Citation

El-Sadr WM, Manneheimer S, Grant L, Matts J. Use of PCP and MAC prophylaxis among eligible patients with and without CD4+ rebound. 39th Intersci Conf Antimicrob Agents Chemother. 1999 Sept 26-29