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NCT00000895 Clinical Trial

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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000895
Other study ID # ACTG 341
Secondary ID 11312
Status Completed
Phase N/A
First received
Last updated
Est. completion date August 2001

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

Clinical Trial 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.

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.]

Recruitment information / eligibility
Status Completed
Enrollment 85
Est. completion date August 2001
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nelfinavir mesylate

• Nevirapine

• Azithromycin

Locations
Country Name City State
United States Emory Univ Atlanta Georgia
United States Univ of Alabama at Birmingham Birmingham Alabama
United States SUNY / Erie County Med Ctr at Buffalo Buffalo New York
United States Cook County Hosp Chicago Illinois
United States Northwestern Univ Med School Chicago Illinois
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Univ of Cincinnati Cincinnati Ohio
United States Case Western Reserve Univ Cleveland Ohio
United States Ohio State Univ Hosp Clinic Columbus Ohio
United States Univ of Texas Southwestern Med Ctr of Dallas Dallas Texas
United States Univ of Texas, Southwestern Med Ctr of Dallas Dallas Texas
United States Univ of Texas Galveston Galveston Texas
United States Division of Inf Diseases/ Indiana Univ Hosp Indianapolis Indiana
United States Indiana Univ Hosp Indianapolis Indiana
United States Univ of Southern California / LA County USC Med Ctr Los Angeles California
United States Univ of Miami School of Medicine Miami Florida
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Beth Israel Med Ctr New York New York
United States St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr New York New York
United States Univ of Pennsylvania at Philadelphia Philadelphia Pennsylvania
United States Univ of Rochester Medical Center Rochester New York
United States Univ of California / San Diego Treatment Ctr San Diego California
United States Univ of Washington Seattle Washington
United States Stanford Univ Med Ctr Stanford California
United States Howard Univ Washington District of Columbia
United States Julio Arroyo West Columbia South Carolina

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 sub — View Citation

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