Washington, District of Columbia 20059

  • HIV Infections

Purpose:

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.


Study summary:

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.]


Criteria:

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.


Study is Available At:


Original ID:

ACTG 341


NCT ID:

NCT00000895


Secondary ID:


Study Acronym:


Brief Title:

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


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

85


Enrollment Type:


Overall Contact Information

Official Name:Rob Roy MacGregor
Study Chair

Study Dates

Primary Completion Date:August 2001
Primary Completion Type:Actual
Verification Date:March 2011
Last Changed Date:March 1, 2011
First Received Date:November 2, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:Nelfinavir mesylate
Intervention Type:Drug
Name:Nevirapine
Intervention Type:Drug
Name:Azithromycin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:MacGregor RR, Hafner R, Wu JW, Murphy RL, Perlman DC, Bermudez LE, Inderlied CB, Picker LJ, Wallis RS, Andersen JW, Mahon LF, Koletar SL, Peterson DM; ACTG Protocol 341 Team. Clinical, microbiological, and immunological characteristics in HIV-infected subjects at risk for disseminated Mycobacterium avium complex disease: an AACTG study. AIDS Res Hum Retroviruses. 2005 Aug;21(8):689-95.
PMID:16131307

Data Source: ClinicalTrials.gov

Date Processed: March 30, 2020

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