Mycobacterium Avium-intracellulare InfectionNCT00000895
A Study to Learn More About MAC Disease and the Use of Anti-HIV Drugs in Patients With Advanced HIV Infection
A study testing Nelfinavir mesylate, Nevirapine and Azithromycin in people with Mycobacterium Avium-intracellulare Infection and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 26 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mycobacterium Avium-intracellulare Infection, HIV Infections
- What is being tested?
- Nelfinavir mesylate, Nevirapine and Azithromycin
- How many people
- 85 participants
- Where
- 26 sitesUnited States
- Study dates
- Start not givento Aug 2001
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Emory Univ
Atlanta, Georgia, 30308
Univ of Alabama at Birmingham
Birmingham, Alabama, 35294
SUNY / Erie County Med Ctr at Buffalo
Buffalo, New York, 14215
Northwestern Univ Med School
Chicago, Illinois, 60611
Cook County Hosp
Chicago, Illinois, 60612
Rush Presbyterian - Saint Luke's Med Ctr
Chicago, Illinois, 60612
Univ of Cincinnati
Cincinnati, Ohio, 452670405
Case Western Reserve Univ
Cleveland, Ohio, 44106
Ohio State Univ Hosp Clinic
Columbus, Ohio, 432101228
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235
Univ of Texas, Southwestern Med Ctr of Dallas
Dallas, Texas, 75390
Univ of Texas Galveston
Galveston, Texas, 775550435
Indiana Univ Hosp
Indianapolis, Indiana, 462025250
Division of Inf Diseases/ Indiana Univ Hosp
Indianapolis, Indiana, 46202
Univ of Southern California / LA County USC Med Ctr
Los Angeles, California, 900331079
Univ of Miami School of Medicine
Miami, Florida, 331361013
Beth Israel Med Ctr
New York, New York, 10003
Bellevue Hosp / New York Univ Med Ctr
New York, New York, 10016
St Vincent's Hosp / Mem Sloan-Kettering Cancer Ctr
New York, New York, 10021
Univ of Pennsylvania at Philadelphia
Philadelphia, Pennsylvania, 19104
Univ of Rochester Medical Center
Rochester, New York, 14642
Univ of California / San Diego Treatment Ctr
San Diego, California, 921036325
Univ of Washington
Seattle, Washington, 98104
Stanford Univ Med Ctr
Stanford, California, 943055107
Howard Univ
Washington D.C., District of Columbia, 20059
Julio Arroyo
West Columbia, South Carolina, 29169
About this study
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
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.
Read the 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.]
- Being tested
- Nelfinavir mesylate, Nevirapine, Azithromycin
- Keywords
- AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, HIV-1, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Mycobacterium avium Complex, Bacteremia, Nevirapine, HIV Protease Inhibitors, Risk Factors, RNA, Viral, Reverse Transcriptase Inhibitors, Nelfinavir
- Medical subject headings
- Mycobacterium avium-intracellulare Infection, HIV Infections, AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nelfinavir mesylateDrug
NevirapineDrug
AzithromycinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mycobacterium Avium-intracellulare InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Enrolment
- 85 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rob Roy MacGregor, Study chairDavid Perlman, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000895
- Sponsor's protocol ID
- ACTG 341
- Other IDs
- 11312
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 1999
- Last updated
- 29 Oct 2021
- Results posted
- No
Publications
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. doi: 10.1089/aid.2005.21.689.
PubMed 16131307
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00000895
- Acronym / sponsor ID
- ACTG 341
- Keywords
- AIDS-Related Opportunistic Infections, Mycobacterium avium-intracellulare Infection, HIV-1, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome, Mycobacterium avium Complex, Bacteremia, Nevirapine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Aug 2001 (actual)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nelfinavir mesylate | Drug | – |
| Nevirapine | Drug | – |
| Azithromycin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Results publication: PubMed 16131307MacGregor 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. doi: 10.1089/aid.2005.21.689.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rob Roy MacGregor study chair
David Perlman study chair
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nelfinavir mesylate, Nevirapine and Azithromycin in people with Mycobacterium Avium-intracellulare Infection and HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 26 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00000895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021; AzTrials last refreshed its copy on 30 Oct 2026.