Antiretroviral therapy

Studies/Projects
Publications

ACCELERATE

Post Date:

2022-09-08

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Under the directives of PEPFAR, with support from USAID, and in collaboration with NACO, the ACCELERATE program provides HIV/AIDS services for high-risk populations including key populations affected by HIV throughout India and technical assistance (TA) to the national, state, and district HIV/AIDS...

Mitr Clinic - Pride and Beyond

Post Date:

2022-09-08

USAID and PEPFAR supported Program ACCELERATE, implemented by Johns Hopkins University School of Medicine (JHU SOM) in partnership with YRG Care, The Fenway Institute and the Blue Lotus Advisory under the leadership of National AIDS Control Organisation (NACO) and State AIDS Control Societies (SACS...

Kidaba Thawai (Fearless Souls) Documentary

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2022-09-08

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The documentary Kidaba Thawai is based on ACCELERATE's intervention - an Adolescent Friendly Health Center (AFHC) in Imphal, Manipur. The documentary discusses AFHC's comprehensive health care delivery model (HIV and non-HIV services) which contributes to the holistic development of adolescents. A...

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

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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)

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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...

The Sentinel Research Network of IeDEA: A Prospective Cohort among People Living with HIV

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2020-03-12

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This study is nested within the TREAT Asia HIV Observational Database initiative. The global scale up of antiretroviral therapy (ART) has significantly improved the immune recovery and life expectancy of people living with HIV (PLHIV). However, PLHIV on long-term ART now face health challenges...

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...

Markers of Lung Impairment in HIV-TB Coinfected Indian Adults

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2019-12-11

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Objectives/Aims We will compare the degree of lung impairment between HIV-TB co-infected adults (HIV-TB group) and TB cases without HIV co-infection (TB group) who successfully complete TB therapy. We hypothesize that the HIV-TB group will have a greater degree of lung...

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

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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)

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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...

P2010: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants “VESTED”

Post Date:

2019-02-06

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This study was terminated September 2, 2021 Full Title: P2010: Phase III Study of the Virologic Efficacy and Safety of Dolutegravir-Containing versus Efavirenz-Containing Antiretroviral Therapy Regimens in HIV-1-Infected Pregnant Women and their Infants “...

Assessment of Depression and Anxiety among HIV-infected Adolescents in Pune, India

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2018-07-22

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This study is conducted under the TREAT Asia Network and funded by amfAR. PURPOSE The purpose of this study is to estimate the prevalence of depression and anxiety among adolescents living with HIV in India and their determinants. DESIGN...

Impact of HIV and Diabetes Mellitus on TB Drug Resistance and Recurrence

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2017-03-02

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This study was terminated in January 2021. Tuberculosis (TB) is the leading cause of mortality globally. With increasing burden of HIV and diabetes mellitus (DM), there is a critical need to understand the microbial response and ensuing disease dynamics of TB in the HIV-infected and diabetic host...

TREAT Asia Pediatric HIV Observational Database

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2017-02-09

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Studies conducted under the TREAT Asia Network and funded by amfAR. TREAT Asia Pediatric HIV Observational Database (TApHOD) is a collaborative observational cohort study of infants, children, and adolescents living with HIV. TApHOD study participants are...

TREAT Asia Observational Database

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2017-02-09

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Study conducted under the TREAT Asia Network and funded by amfAR. The TREAT Asia Observational Database's primary study objective is to: Examine HIV natural history, including the relationship between access to ART, demographics, and...

Cost-effectiveness of Xpert MTB/RIF for Diagnosing Pulmonary Tuberculosis in HIV-positive Patients

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2016-12-01

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This study was terminated October 8, 2019. This is a prospective cross-sectional study which will be conducted at BJGMC in Pune, India. The aim of this study is to see whether Xpert MTB/RIF is useful for early detection of pulmonary tuberculosis, and therefore cost-effective, as compared with...

Prevalence Survey of Risk Factors for Tuberculosis and Non-communicable Diseases in an HIV-positive Population in Pune, India

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2015-08-17

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This study is conducted under the TREAT Asia Network and funded by amfAR. The primary objective of this study is to assess the prevalence of risk factors for tuberculosis and non-communicable diseases (NCDs)--coronary artery disease and diabetes mellitus--...

ART Study 1: Database: Epidemiology of HIV/AIDS and Associated Comorbidities in a Public Antiretroviral Treatment (ART) Clinic at BJGMC in Pune

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2014-06-14

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Hinduja Hospital

Since 2004, the National AIDS Control Program of India has been rolling out free antiretroviral therapy. Byramjee Jeejeebhoy Government Medical College (BJGMC), located in Pune, India, is now the largest HIV clinic in India, with over 26,000 adult and pediatric patients registered since 2005...

A Prospective Study Evaluating the Role of Cryptococcal Antigen Screening among HIV-infected Adults with Low CD4 Counts

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2011-01-01

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This prospective observational study aimed to evaluate the burden of cryptococcal disease among approximately 200 HIV-infected adults with low CD4 cell counts in Pune, India to determine whether a Cryptococcal screening strategy should be the standard of care among patients with advanced HIV...

BWI CTU: Baltimore-Washington-India Clinical Trials Unit

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2007-02-02

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Comprising clinical trial sites at Johns Hopkins Medicine in Baltimore, Whitman Walker Health in Washington, DC, and the BJGMC-CCGHE collaboration in Pune, India, the Baltimore-Washington-India Clinical Trials Unit (BWI-CTU) is one of only 25 international HIV/TB clinical trial sites funded by the...

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Pro-inflammatory and pro-resolving lipid mediators of inflammation in HIV: effect of aspirin intervention

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2023-03-01

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eBioMedicine

Background: Persons with HIV (PWH) have an increased risk of cardiovascular disease (CVD) compared to HIV-seronegative individuals (SN). Inflammation contributes to this risk but the role of lipid mediators, with central roles in inflammation, in HIV infection remain to be established; further...

Self-Reported Antiretroviral Adherence: Association with Maternal Viral Load Suppression in Postpartum Women Living with HIV-1 from Promoting Maternal and Infant Survival Everywhere (PROMISE), a Randomized Controlled Trial in Sub-Saharan Africa and India

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2023-01-01

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Journal of Acquired Immune Deficiency Syndrome

Introduction: Optimal adherence to antiretroviral therapy (ART) is crucial to promoting maternal–infant health. Setting: Fourteen sites in 7 countries within sub-Saharan Africa and India. Methods: The multicomponent, open-label strategy PROMISE trial enrolled breastfeeding mother–infant pairs not...

Drug use stigma, antiretroviral therapy use, and HIV viral suppression in a community-based sample of people with HIV who inject drugs

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2022-10-06

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AIDS

Drug use stigma may be a barrier to HIV viral suppression among people with HIV who inject drugs, thereby hindering efforts to achieve HIV control.

Geographical Differences in the Self-Reported Functional Impairment of People with HIV and Associations with Cardiometabolic Risk

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2022-09-30

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Clinical Infectious Disease

Background We sought to explore multinational differences in functional status by global burden of disease (GBD) regions in the REPRIEVE cohort. Methods REPRIEVE is a prospective, double-blind, randomized, placebo-controlled, multicenter, phase III primary cardiovascular prevention study of...

Population Pharmacokinetic Modeling and Simulation of Rifapentine Allow Concomitant Antiretroviral Therapy with Efavirenz and Non-Weight Based Dosing

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2022-09-20

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Antimicrobial Agents and Chemotherapy

ABSTRACT The Brief Rifapentine–Isoniazid Efficacy for TB Prevention/A5279 trial demonstrated a 1-month daily regimen of rifapentine and isoniazid was noninferior to 9 months of isoniazid alone for preventing TB in persons living with HIV (PLWH). Our objective was to evaluate rifapentine...

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;...

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

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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...

Clinical and Immunological Markers of Pulmonary Impairment among People Living with HIV in India

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2022-05-11

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Open Forum Infectious Diseases

Background Despite antiretroviral therapy, chronic lung diseases remain an important source of morbidity and mortality in people with HIV (PWH). We sought to identify clinical and immunological markers of pulmonary impairment among PWH in India. Methods Two hundred ten adult PWH receiving...

Integrating services for HIV and multidrug-resistant tuberculosis: a global cross-sectional survey among ART clinics in low- and middle-income countries

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2022-03-01

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PLOS Global Public Health

Tuberculosis (TB) is the leading cause of death among PLHIV and multidrug-resistant-TB (MDR-TB) is associated with high mortality. We examined the management for adult PLHIV coinfected with MDR-TB at ART clinics in lower income countries. Between 2019 and 2020, we conducted a cross-sectional survey...

A mobile health-facilitated behavioral intervention for community health workers improves exclusive breastfeeding and early infant HIV diagnosis in India: A cluster randomized trial

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2020-07-03

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Journal of the International AIDS Society

When community health workers used a mobile health intervention with HIV+ women to deliver care, there was a higher uptake of exclusive breastfeeding at two months and early infant HIV diagnosis at six weeks

Trends and gender differences in access to HIV care with scale up of national HIV treatment guidelines in India

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2020-06-24

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Journal of the International Association of Providers of AIDS Care

Test and treat is the current global standard, yet sex differences persist in access to HIV care. We assessed the differences in presentation and antiretroviral therapy (ART) uptake by sex and ART-eligibility period among ART-naive adults registered at a public ART center in India. Four ART...

TB prevention strategies and unanswered questions for pregnant and postpartum women living with HIV: the need for improved evidence

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2020-03-23

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Journal of the International AIDS Society

World TB Day viewpoint on the need for more data about TB treatment for pregnant and postpartum women in J Int AIDS Soc by Drs. Jyoti Mathad and Amita Gupta.

High prevalence of late presentation of ART-naïve perinatally infected children for care in Pune, India

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2020-02-19

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AIDS Care

AIDS Care : There is an urgent need to identify strategies that improve linkage of perinatally infected ART-naïve children to care, and earlier than what is currently observed.

A parsimonious host inflammatory biomarker signature predicts incident TB and mortality in advanced HIV

Post Date:

2019-11-25

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Clinical Infectious Diseases

BACKGROUND: People with advanced HIV (CD4<50) remain at high risk of TB or death despite the initiation of antiretroviral therapy. We aimed to identify immunological profiles that were most predictive of incident TB disease and death. METHODS: The REMEMBER randomized clinical trial enrolled 850...

Incidence of tuberculosis in HIV-infected adults on first- and second-line antiretroviral therapy in India

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2019-10-29

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BMC Infectious Diseases

In this study among people living with HIV, Akshay Gupte and colleagues found that the risk of acquiring tuberculosis was higher in those receiving first-line antiretrovial therapy versus those receiving second-line medications.

Isoniazid preventive therapy in HIV-infected pregnant and postpartum women

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2019-10-03

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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.

Development and validation of HIV-ASSIST, an online, educational, clinical decision support tool to guide patient-centered ARV regimen selection

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2019-10-01

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JAIDS Journal of Acquired Immune Deficiency Syndromes

Background: Multiple antiretroviral (ARV) regimens are effective at achieving HIV viral suppression, but differ in pill burden, side effects, barriers to resistance, and impact on comorbidities. Current guidelines advocate for an individualized approach to ARV regimen selection, but synthesizing...

Inclusion of key populations in clinical trials of new antituberculosis treatments: Current barriers and recommendations for pregnant and lactating women, children, and HIV-infected persons

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2019-08-15

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PLOS Medicine

PLOS Medicine: Dr. Amita Gupta and colleagues discuss the scientific and ethical basis for including pregnant and lactation women, children, and HIV+ patients in tuberculosis therapeutic clinical trials.

Third-line antiretroviral therapy in low-income and middle-income countries (ACTG A5288): a prospective strategy study

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2019-07-29

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Lancet HIV

BACKGROUND: Antiretroviral therapy (ART) management is challenging for individuals in resource-limited settings presenting for third-line treatment because of complex resistance patterns, partly due to reduced access to viral load monitoring. We aimed to evaluate use of newer...

Long-acting or extended-release antiretroviral products for HIV treatment and prevention in infants, children, adolescents, and pregnant and breastfeeding women: knowledge gaps and research priorities

Post Date:

2019-07-15

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Lancet HIV

Lancet HIV : This paper summarizes findings of the Long acting/Extended Release Antiretroviral Resource Program workshop, and offers recommendations for developing ARV products for HIV treatment and prevention in infants, children, adolescents, and pregnant and breastfeeding women

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