ACTG

Studies/Projects
Publications

A5362: A Phase IIc Trial of Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study

Post Date:

2021-06-15

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Primary Hypothesis A 3-month regimen of rifapentine/isoniazid/pyrazinamide/ethambutol (PHZE) with clofazimine (CFZ) dosed as 100 mg daily with a 2-week 300 mg daily loading dose (Arm 1) will demonstrate early efficacy (time to 12-week liquid culture conversion) relative to standard of care (SOC) (...

A5300B/I2003B: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx)

Post Date:

2019-08-19

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Dr. Amita Gupta is Protocol Co-chair for this multinational clinical trial. BACKGROUND The World Health Organization (WHO) estimates that there were 480,000 incident cases of MDR-TB globally in 2015. MDR-TB has been shown to be almost twice as common in TB...

A5300B/I2003B: Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients (PHOENIx)

Post Date:

2019-08-19

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Dr. Amita Gupta is Protocol Co-chair for this multinational clinical trial. BACKGROUND The World Health Organization (WHO) estimates that there were 480,000 incident cases of MDR-TB globally in 2015. MDR-TB has been shown to be almost twice as common in TB...

A5302: BioBank for Surrogate Marker Research for TB (B-SMART)

Post Date:

2017-11-21

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This study was terminated September 1, 2021. This study is conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. A5302 is a multi-center trial of the AIDS Clinical Trials Group (ACTG) in collaboration...

A5332: Randomized Trial to Prevent Vascular Events in HIV – REPRIEVE

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2017-06-09

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This study is conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. This is a prospective, double-blind, randomized, placebo-controlled, multicenter efficacy study in 6500 subjects, with individual subjects to be followed...

A5349: Rifapentine-containing Treatment Shortening Regimens for Pulmonary Tuberculosis: A Randomized, Open-label, Controlled Phase 3 Clinical Trial

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2017-06-05

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This study is conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. This is an international, multicenter, randomized, controlled, open-label, 3-arm, phase 3 non-inferiority trial. Primary Objectives: To evaluate the efficacy of a rifapentine-...

A5300/IMPAACT2003: Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design

Post Date:

2015-09-01

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This clinical trial was terminated July 18, 2017. It was a study conducted under both the AIDS Clinical Trial Group (ACTG) and the the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, and funded by the U.S. National Institutes of Health. Dr...

A5290: A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifampin-Based Tuberculosis Treatment versus a Standard-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen with Rifabutin-Based Tuberculosis...

Post Date:

2015-07-07

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This study was terminated February 23, 2016; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health.. Full Title: A5290, A Randomized, Phase 2b Study of a Double-Dose Lopinavir/Ritonavir-Based Antiretroviral Regimen...

A5279: Phase III Clinical Trial of Ultra-Short-Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV-infected Individuals with Latent Tuberculosis Infection

Post Date:

2014-06-30

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This study ended April 27, 2015; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. Dr. Amita Gupta was Protocol Co-Vice Chair for this multinational clinical trial being conducted in Botswana, Brazil, Haiti,...

A5288: MULTIOCTAVE, Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure

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2012-07-16

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This study was terminated in March 2020. It was a mult-country clinical trial conducted in Brazil, Haiti, India, Kenya, Malawi, Peru, South Africa, Thailand, Uganda, and Zambia under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. ...

A5273: Multicenter Study of Options for Second-Line Effective Combination Therapy (SELECT)

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2011-05-12

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This study was terminated May 2, 2017; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. This was a multinational clinical trial conducted in Brazil, India, Kenya, Malawi, Peru, South Africa, Tanzania, Thailand...

A5282: A Randomized, Phase II Trial to Compare an HPV Test-and-Treat Strategy to a Cytology-Based Strategy for Prevention of CIN 2+ in HIV-Infected Women

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2011-03-15

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Indo-JHU partnership work on this trial was officially terminated September 10, 2018; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. This multi-country trial is being conducted in Botswana, Haiti, India,...

A5225: Phase I/II Dose-Finding Study of High-Dose Fluconazole Treatment in AIDS-Associated Cryptococcal Meningitis

Post Date:

2009-04-22

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This trial was terminated in March 2015; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. This multi-country study was conducted in India, Kenyam Peru, South Africa, Thailand, Uganda, United States, and...

Impact of Malnutrition on HIV Treatment Failure in Resource-limited Settings

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2009-04-02

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This study, NWCS 319, was terminated August 20, 2019. Highly active antiretroviral therapy (HAART) has reduced morbidity and mortality among HIV-infected persons worldwide. However, early treatment failure (i.e. WHO stage 3 or 4 illnesses or death...

A5207: Maintaining Options for Mothers Study (MOMS): A Phase II Randomized Comparison of Three Antiretroviral Strategies Administered for 7 or 21 Days to Reduce the Emergence of Nevirapine Resistant HIV-1 Following a Single Intrapartum Dose of Nevirapine

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2004-12-20

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This study was terminated January 16, 2014; it was conducted under the AIDS Clinical Trials Group (ACTG) and funded by the U.S. National Institutes of Health. A major disadvantage of giving SD NVP is the potential for maternal development of NVP resistance and additional...

A5175: PEARLS Evaluation of the Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor- Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Individuals

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2004-07-27

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Full Title: A Phase IV, Prospective, Randomized, Open-Label Evaluation of the Efficacy of Once-Daily Protease Inhibitor and Once Daily Non-Nucleoside Reverse Transcriptase Inhibitor Containing Therapy Combinations for Initial Treatment of HIV-1 Infected Individuals from Resource-Limited...

Mycobacterium tuberculosis disease associates with higher HIV-1-specific antibody responses

Post Date:

2023-05-19

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Science Direct

Mycobacterium tuberculosis (Mtb) is the most common infection among people with HIV (PWH). Mtb disease-associated inflammation could affect HIV-directed immune responses in PWH. We show that HIV antibodies are broader and more potent in PWH in the presence as compared to the absence of Mtb disease...

Factors associated with prevalent Mycobacterium tuberculosis infection and disease among adolescents and adults exposed to rifampin-resistant tuberculosis in the household

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2023-03-17

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PLOS ONE

Background: Understanding factors associated with prevalent Mycobacterium tuberculosis infection and prevalent TB disease in household contacts of patients with drug-resistant tuberculosis (TB) may be useful for TB program staff conducting contact investigations. Methods: Using data from a cross-...

Isoniazid adherence improves survival and incident tuberculosis at 96 weeks among adults initiating antiretroviral therapy with advanced HIV in multiple high burden settings

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2022-07-03

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Open Forum Infectious Diseases

Background People with human immunodeficiency virus (HIV) and advanced immunosuppression initiating antiretroviral therapy (ART) remain vulnerable to tuberculosis (TB) and early mortality. To improve early survival, isoniazid preventive therapy (IPT) or empiric TB treatment have been evaluated;...

High prevalence of TB infection and disease in child household contacts of adults with rifampin-resistant tuberculosis

Post Date:

2022-05-01

Publication:

Pediatric Infectious Disease Journal

Background: Household contact (HHC) investigation is an important strategy to identify individuals with tuberculosis (TB) exposure, infection and disease, including those who may benefit from tuberculosis preventive therapy (TPT). Data in children exposed to rifampin-resistant TB are limited...

Urine LAM Testing in Advanced HIV-Infected Adults in a Trial of Empiric TB Therapy

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2021-08-15

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Clinical Infectious Diseases

Background The urine lipoarabinomannan (LAM) antigen test is a tuberculosis (TB) diagnostic test with highest sensitivity in individuals with advanced human immunodeficiency virus (HIV). Its role in TB diagnostic algorithms for HIV-positive outpatients remains unclear. Methods The AIDS Clinical...

One month of rifapentine plus isoniazid to prevent HIV-related tuberculosis

Post Date:

2019-03-14

Publication:

New England Journal of Medicine

Exciting findings from A5279: One month of Rifapentine with isonaizid is as effective as a 9-month course of isoniazid alone!