South Africa

Studies/Projects
Publications

1 to 3 HP

Post Date:

2023-01-24

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Protocol Title: A Randomized Trial Comparing Treatment Completion of Daily Rifapentine & Isoniazid for One Month (1HP) to Weekly Rifapentine & Isoniazid For 3 Months (3HP) In Persons Living With HIV and in HIV-negative Household Contacts of Recently Diagnosed Tuberculosis Patients, The “One...

Epidemiologic Factors Associated with TB Treatment Outcomes Across Report International Consortia

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2021-08-12

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Rationale: RePORT International was designed to enable cross-consortium data analysis. Now that a large number of consortium sites have completed participant enrollment in Common Protocol Cohort A, we can proceed with large-scale analysis of aligned RePORT data. The current study will harmonize and...

P2026: Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs during Pregnancy and Postpartum

Post Date:

2021-05-18

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IMPAACT P1026s, the predecessor of this study, was first approved in 2003. P1026s enrolled over 1000 pregnant/postpartum women, studied the PK of more than 25 HIV and TB drugs in these women and published 27 manuscripts presenting these data. P1026s data was cited in 32% of the 76 perinatal...

The Pharmacokinetics, Safety and Acceptability of New Child-Friendly Formulations of Clofazimine and Moxifloxacin in Children Routinely Treated for Rifampicin-Resistant Tuberculosis (CATALYST)

Post Date:

2021-04-26

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PK, safety and acceptability data and practical guidance on the optimal dosing of new more child-friendly formulations of moxifloxacin and clofazimine in children are urgently needed to inform their current and future use in children with Rifampicin-Resistant TB (RR-TB). Both medications have a key...

Pharmacokinetic Assessment of MDR-TB Drugs in the Treatment of TB Meningitis

Post Date:

2020-08-23

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Hinduja Hospital

Rationale: MDR-TBM is a devastating disease with high mortality and severe neurologic sequelae among survivors. We recognize the importance of sufficient drug concentrations at the site of infection for efficacy of anti-TB drugs and believe it is likely that drug distribution into brain and CSF...

Pregnancy Associated Immune Responses to Tuberculosis and HIV in India and South Africa (PARTHISA)

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2020-01-14

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Dr. Jyoti Mathad is Co-PI of this study. Purpose: Tuberculosis (TB) is a leading cause of maternal mortality, especially among HIV-infected women. Women are most likely to develop active TB during and immediately after pregnancy. The immunologic conditions responsible for this phenomenon are not...

Characterization of Genomics and Metabolomics among Individuals Highly-Exposed, but Resistant to MTB Infection

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2018-12-13

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New study launched in India & South Africa to identify functional relationships between genomics & metabolomics, & to characterize fundamental biological systems underlying resistance to Mtb infection.

Host RNA Expression for Diagnosis and Monitoring of Pediatric TB in Africa and India

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2018-12-13

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We are leveraging the RePORT platform by including a cohort of Indian children together with South African children in a large validation study to study on changes in gene expression profiles during treatment for TB

A5253: Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnostics in HIV-Infected Individuals

Post Date:

2009-03-19

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This study was terminated October 15, 2014. An estimated 3 million HIV-infected individuals will enter programs for antiretroviral (ARV) treatment in the coming year, with projected rates of requirement for ARV therapy extending to more than 10 million in sub-Saharan Africa...

P1070: Dose-Finding and Pharmacogenetic Study of Efavirenz in HIV-Infected and HIV/TB Co-Infected Infants and Children ≥ 3 Months to < 36 Months of Age

Post Date:

2008-12-05

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This study ended March 10, 2015. This multi-country trial was conducted in India, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe, under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of...

A Stand Alone Study for Participants of A5175 (A Phase IV, 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 Treatme

Post Date:

2006-05-02

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Globally, 40 million individuals are HIV-infected with 5 million new infections occurring each year; rates are increasing. Three million individuals died from HIV/AIDS in 2003. The global burden of the HIV epidemic is staggering, but in the short term, it is largely unfelt in the developed world...

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

Post Date:

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...

Pregnancy in Women with HIV in a Tuberculosis Preventive Therapy Trial

Post Date:

2022-08-01

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Publication:

JAIDS

Background: Tuberculosis preventive therapy (TPT) is recommended for people with HIV infection, including during pregnancy. The effect of TPT exposure at conception and during pregnancy is poorly documented. Methods: We report pregnancy outcomes among South African women...

Prevalence of neurotoxicity symptoms among postpartum women on Isoniazid Preventive Therapy and Efavirenz-based treatment for HIV—An exploratory objective of the IMPAACT P1078 randomized trial

Post Date:

2022-06-21

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BMC Pregnancy and Childbirth

Background This exploratory analysis investigates the prevalence and risk factors of neurocognitive toxicity in postpartum women on HIV treatment in response to a concern of an Isoniazid Preventive Therapy (IPT)/Efavirenz interaction. Trial Design Pregnant women on HIV treatment from countries with...

Isoniazid preventive therapy in HIV-infected pregnant and postpartum women

Post Date:

2019-10-03

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Publication:

New England Journal of Medicine

New England Journal of Medicine: Dr. Amita Gupta and colleagues found that the current standard of care given to HIV+ pregnant women to prevent TB should wait until 12 weeks after delivery. The study underscores the need to include pregnant women in clinical trials.

Vitamin A and D deficiencies associated with incident tuberculosis in HIV-infected patients initiating antiretroviral therapy in multinational case-cohort study

Post Date:

2017-02-06

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Journal of Acquired Immune Deficiency Syndromes

Introduction: Numerous micronutrients have immunomodulatory roles that may influence risk of tuberculosis (TB), but the association between baseline micronutrient deficiencies and incident TB after antiretroviral (ART) initiation in HIV-infected individuals is not well characterized. ...

Sex-related differences in inflammatory and immune activation markers before and after combined antiretroviral therapy initiation

Post Date:

2016-10-01

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Journal of Acquired Immune Deficiency Syndromes

Background: Women progress to death at the same rate as men despite lower plasma HIV RNA (viral load). We investigated sex-specific differences in immune activation and inflammation as a potential explanation. Methods: Inflammatory and immune activation markers [...

Inflammation and change in body weight with antiretroviral therapy initiation in a multinational cohort of HIV-infected adults

Post Date:

2016-04-01

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The Journal of Infectious Diseases

Background: Both wasting and obesity are associated with inflammation, but the extent to which body weight changes influence inflammation during human immunodeficiency virus infection is unknown. Methods: Among a random virologically suppressed participants of the...

Persistently elevated C-reactive protein level in the first year of antiretroviral therapy, despite virologic suppression, is associated with HIV disease progression in resource-constrained settings

Post Date:

2016-04-01

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The Journal of Infectious Diseases

A case-cohort analysis of human immunodeficiency virus (HIV)-infected individuals receiving antiretroviral therapy (ART) was performed within a multicountry randomized trial (PEARLS) to assess the prevalence of persistently elevated C-reactive protein (CRP) levels, based on serial...

Empirical tuberculosis therapy versus isoniazid in adult outpatients with advanced HIV initiating antiretroviral therapy (REMEMBER): a multicountry open-label randomised controlled trial

Post Date:

2016-03-19

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The Lancet

Background: Mortality within the first 6 months after initiating antiretroviral therapy is common in resource-limited settings and is often due to tuberculosis in patients with advanced HIV disease. Isoniazid preventive therapy is recommended in HIV-positive adults, but subclinical...

Low Vitamin-D levels combined with PKP3-SIGIRR-TMEM16J host variants is strongly associated with tuberculosis and death in HIV-infected and -exposed infants

Post Date:

2016-02-12

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PLOS One

Background: This study examined the associations of 25-hydroxyvitamin D and specific host genetic variants that affect vitamin D levels or its effects on immune function, with the risk of TB or mortality in children. Methods: A case-cohort sample of 466 South African infants...

Prevalence and risk factors of micronutrient deficiencies pre- and post-antiretroviral therapy (ART) among a diverse multicountry cohort of HIV-infected adults

Post Date:

2016-02-10

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Clinical Nutrition

Background & Aims: HIV-infected adults have increased risk of several individual micronutrient deficiencies. However, the prevalence and risk factors of concurrent and multiple micronutrient deficiencies and whether micronutrient concentrations change after antiretroviral therapy (ART)...

Pediatric tuberculous meningitis: model-based approach to determining optimal doses of anti-tuberculosis drugs for children

Post Date:

2015-10-22

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Clinical Pharmacology and Therapeutics

Pediatric tuberculous meningitis (TBM) is a highly morbid, often fatal disease. Standard treatment includes isoniazid, rifampin, pyrazinamide, and ethambutol. Current rifampin dosing achieves low cerebrospinal fluid (CSF) concentrations, and CSF penetration of ethambutol is poor. In adult...

Soluble CD14: An independent biomarker for risk of HIV mother-to-child transmission in setting of pre- and post-exposure antiretroviral prophylaxis

Post Date:

2015-10-06

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The Journal of Infectious Diseases

Elevated soluble CD14 (sCD14) concentrations, a marker of monocyte activation, predicts adverse outcomes in human immunodeficiency virus (HIV)-infected adults. To examine the association of sCD14 concentrations with the risk of mother-to-child transmission (MTCT) of HIV, we nested a case-...

Pre-cART elevation of CRP and CD4+ T-cell immune activation associated with HIV clinical progression in a multinational case-cohort study

Post Date:

2015-10-01

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Journal of Acquired Immune Deficiency Syndromes

Background: Despite the success of combination antiretroviral therapy (cART), a subset of HIV-infected patients who initiate cART develop early clinical progression to AIDS; therefore, some cART initiators are not fully benefitted by cART. Immune activation pre-cART may predict clinical...

Concurrent anemia and elevated CRP predicts HIV clinical treatment failure, including TB, post-antiretroviral therapy initiation

Post Date:

2015-07-01

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Clinical Infectious Diseases

Background: Anemia is a known risk factor for clinical failure following antiretroviral therapy (ART). Notably, anemia and inflammation are interrelated, and recent studies have associated elevated C-reactive protein (CRP), an inflammation marker, with adverse human immunodeficiency virus (...

Efavirenz pharmacokinetics in HIV-infected persons receiving rifapentine and isoniazid for tuberculosis prevention

Post Date:

2015-06-16

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Publication:

Clinical Infectious Diseases

Background: Concomitant use of rifamycins to treat or prevent tuberculosis can result in subtherapeutic concentrations of antiretroviral drugs. We studied the interaction of efavirenz with daily rifapentine and isoniazid in human immunodeficiency virus (HIV)-infected individuals receiving a 4...

C-reactive protein (CRP), interferon gamma-inducible protein 10 (IP-10), and lipopolysaccharide (LPS) are associated with risk of tuberculosis after initiation of antiretroviral therapy in resource-limited settings

Post Date:

2015-02-26

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PLOS One

Objective: The association between pre-antiretroviral (ART) inflammation and immune activation and risk for incident tuberculosis (TB) after ART initiation among adults is uncertain. Design: Nested case-control study (n = 332) within ACTG PEARLS trial of...

Pre-antiretroviral therapy selenium status predicts WHO stages 3, 4 or death but not virologic failure post-antiretroviral therapy

Post Date:

2014-11-13

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Nutrients

A case-cohort study, within a multi-country trial of antiretroviral therapy (ART) efficacy (Prospective Evaluation of Antiretrovirals in Resource Limited Settings (PEARLS)), was conducted to determine if pre-ART serum selenium deficiency is independently associated with human immunodeficiency...

25-Hydroxyvitamin D insufficiency and deficiency is associated with HIV disease progression and virological failure post-antiretroviral therapy initiation in diverse multinational settings

Post Date:

2014-07-15

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Publication:

The Journal of Infectious Diseases

Background: Low 25-hydroxyvitamin D (25(OH)D) has been associated with increased HIV mortality, but prospective studies assessing treatment outcomes after combination antiretroviral therapy (cART) initiation in resource-limited settings are lacking. Methods...

Change in Vitamin D levels occurs early after antiretroviral therapy initiation and depends on treatment regimen in resource-limited settings

Post Date:

2014-04-21

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PLOS One

Background: Vitamin D has wide-ranging effects on the immune system, and studies suggest that low serum vitamin D levels are associated with worse clinical outcomes in HIV. Recent studies have identified an interaction between antiretrovirals used to treat HIV and reduced serum vitamin D...

Screening for pulmonary tuberculosis in HIV-infected individuals: AIDS Clinical Trials Group Protocol A5253

Post Date:

2013-04-15

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Publication:

International Journal of Tuberculosis and Lung Disease

Background: Improved tuberculosis (TB) screening is urgently needed for human immunodeficiency virus (HIV) infected patients. Methods: An observational, multi-country, cross-sectional study of HIV-infected patients to compare a standardized diagnostic...

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