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

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00000895

Collaborator

(none)

Enrollment

Locations

3.3

Patients Per Site

Study Details

Study Description

Brief Summary

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.

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

Detailed Description

The intent of this study is to define more precisely the natural history and immunopathogenesis of MAC disease in the HIV-infected population. It is suggested that MAC disease in AIDS patients results both from specific immunologic deficiencies caused by HIV infection of the host and as a result of specific mycobacterial virulence properties. Therefore, aggressive antiretroviral drug treatment of HIV-infected patients at risk for DMAC due to specific immune deficiencies will improve these immune functions in such a manner as to resist DMAC.

A total of 85 patients will be stratified at baseline into one of three groups:

Group I - 40 patients at high risk for MAC infection are neither followed beyond baseline nor receive study treatment.

Group II - 15 patients with DMAC, i.e., newly diagnosed MAC-bacteremic patients with no more than 72 hours prior treatment for MAC, receive individualized regimen of HAART for 48 weeks: nelfinavir (NEV), nevirapine (NVP), and nucleoside reverse transcriptase inhibitor(s) as per primary physician. Patients are evaluated through clinical, microbiologic, and virologic assessments, and intensive immunologic evaluations at Weeks 12, 24, and 48.

Group III - 30 asymptomatic HIV-infected patients are further stratified (15 patients/stratum) by CD4 count (less than or equal to 50 cells/mm3 or 100-250 cells/mm3). Patients in Group III follow the same HAART regimen and evaluations as Group II patients and continue evaluations for up to 48 weeks, if an acceptable response is found within 12 weeks of entry. Patients in Stratum 1 of Group III receive MAC prophylaxis with azithromycin once weekly with follow-up evaluations as in Group II. Patients in Group III that have a positive MAC blood or bone marrow culture at any time during the study will, from that point on, follow the same schedule of evaluations as patients in Group II.

[AS PER AMENDMENT 11/3/98: Up to 100 evaluable patients will now be studied. Group 2 is now modified to include up to an additional 15 evaluable patients with known MAC bacteremia and less than or equal to 7 days prior MAC treatment who are unable to commit to long-term follow-up (Group 2b); these patients will undergo only baseline evaluations. Group 2a consists of 15 evaluable patients with known MAC bacteremia and less than or equal to 7 days of prior MAC treatment who are willing and able to enter the follow-up phase.]

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Actual Study Completion Date :

Aug 1, 2001

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 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 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ of Alabama at Birmingham	Birmingham	Alabama	United States	35294
2	Univ of Southern California / LA County USC Med Ctr	Los Angeles	California	United States	900331079
3	Univ of California / San Diego Treatment Ctr	San Diego	California	United States	921036325
4	Stanford Univ Med Ctr	Stanford	California	United States	943055107
5	Howard Univ	Washington	District of Columbia	United States	20059
6	Univ of Miami School of Medicine	Miami	Florida	United States	331361013
7	Emory Univ	Atlanta	Georgia	United States	30308
8	Northwestern Univ Med School	Chicago	Illinois	United States	60611
9	Cook County Hosp	Chicago	Illinois	United States	60612
10	Rush Presbyterian - Saint Luke's Med Ctr	Chicago	Illinois	United States	60612
11	Indiana Univ Hosp	Indianapolis	Indiana	United States	462025250
12	Division of Inf Diseases/ Indiana Univ Hosp	Indianapolis	Indiana	United States	46202
13	SUNY / Erie County Med Ctr at Buffalo	Buffalo	New York	United States	14215
14	Beth Israel Med Ctr	New York	New York	United States	10003
15	Bellevue Hosp / New York Univ Med Ctr	New York	New York	United States	10016
16	St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr	New York	New York	United States	10021
17	Univ of Rochester Medical Center	Rochester	New York	United States	14642
18	Univ of Cincinnati	Cincinnati	Ohio	United States	452670405
19	Case Western Reserve Univ	Cleveland	Ohio	United States	44106
20	Ohio State Univ Hosp Clinic	Columbus	Ohio	United States	432101228
21	Univ of Pennsylvania at Philadelphia	Philadelphia	Pennsylvania	United States	19104
22	Julio Arroyo	West Columbia	South Carolina	United States	29169
23	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas	United States	75235
24	Univ of Texas, Southwestern Med Ctr of Dallas	Dallas	Texas	United States	75390
25	Univ of Texas Galveston	Galveston	Texas	United States	775550435
26	Univ of Washington	Seattle	Washington	United States	98104