BWI-CTU

Studies/Projects
Publications

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

Post Date:

2021-05-18

Countries:

Clinical Sites:

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...

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

Post Date:

2019-08-19

Countries:

India

Clinical Sites:

BJGMC

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

Countries:

India

Clinical Sites:

BJGMC

Immune Correlates of LTBI in HIV-exposed Infants

Post Date:

2019-04-29

Countries:

India

About 2 billion people worldwide harbor asymptomatic latent TB infection (LTBI), activation of which results in progression to TB disease. In areas of high tuberculosis (TB) prevalence, infants and young children have a 3-fold higher risk of progression and death from TB at age < 5 years...

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

Countries:

India

Clinical Sites:

BJGMC

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 “...

P2005: A Phase I/II Open-Label, Single-Arm Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Delamanid in Combination with OBR for MDR-TB in HIV-Infected and Uninfected Children with MDR-TB

Post Date:

2018-06-07

Countries:

India

Clinical Sites:

BJGMC

New study will characterize the pharmacokinetics of delamanid using a model-based approach, and evaluate safety and tolerability of over 24 weeks of study treatment in HIV infected and uninfected children.

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

Post Date:

2017-11-21

Countries:

India

Clinical Sites:

BJGMC

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

Post Date:

2017-06-09

Countries:

India

Clinical Sites:

BJGMC

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

Post Date:

2017-06-05

Countries:

India

Clinical Sites:

BJGMC

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

Countries:

India

Clinical Sites:

BJGMC

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

Countries:

India

Clinical Sites:

BJGMC

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...

Inflammation in HIV-infected Pregnant Women: Relationship with Diet, Gut Microbiome and Preterm Birth

Post Date:

2014-10-28

Countries:

India

Clinical Sites:

BJGMC

NIRT

This study was terminated May 7, 2018. P regnancy is a state of relative immunosuppression in order to protect the fetus from being rejected. It has also been shown that the Th-1 helper cell response, which is normally necessary for overcoming TB infection...

Predictive Value of TB-symptom Screen in HIV-infected and HIV-uninfected Pregnant Women in Pune, India

Post Date:

2014-10-28

Countries:

India

Clinical Sites:

BJGMC

This study was terminated July 17, 2017. This is a cross sectional observational study will be conducted at BJGMC to establish what the predictive value of the WHO TB symptom screen is in pregnant women in India. We hypothesize that the WHO TB symptom...

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

Countries:

India

Clinical Sites:

BJGMC

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,...

P1078: A Phase IV Randomized Double-Blind Placebo-Controlled Trial to Evaluate the Safety of Immediate (Antepartum-Initiated) Versus Deferred (Postpartum-Initiated) Isoniazid Preventive Therapy Among HIV-Infected Women in High TB Incidence Settings

Post Date:

2014-04-01

Countries:

India

Clinical Sites:

BJGMC

This is a clinical trial conducted under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health. Dr. Amita Gupta is Protocol Chair for this multinational clinical trial being conducted in...

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

Post Date:

2012-07-16

Countries:

India

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)

Post Date:

2011-05-12

Countries:

India

Clinical Sites:

BJGMC

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

Post Date:

2011-03-15

Countries:

India

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,...

P1073: Study of Immune Reconstitution Inflammatory Syndrome (IRIS) for International Sites Initiating Highly Active Antiretroviral Therapy (HAART) in Infants and Children < 72 Months of Age

Post Date:

2010-11-15

Countries:

India

Clinical Sites:

BJGMC

This study was terminated April 23, 2015. This was a multi-national study conducted in India, South Africa, and Tanzania under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded by the U.S. National Institutes of Health...

P1077BF: Breastfeeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

Post Date:

2010-02-02

Countries:

India

This trial was terminated November 6, 2019. This multi-country trial is being conducted in India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe, conducted under the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network and funded...

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

Post Date:

2020-06-24

Countries:

India

Publication:

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...

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

Post Date:

2020-02-19

Countries:

India

Clinical Sites:

BJGMC

Publication:

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.

Applying a risk-benefit analysis to outcomes in tuberculosis clinical trials

Post Date:

2020-02-03

Publication:

Clinical Infectious Diseases

CID: Analyzing efficacy and safety separately in clinical trials could yield misleading study conclusions if there's an increase in efficacy and a decrease in safety

Assessment of the Xpert assay among new pulmonary tuberculosis suspects with and without diabetes mellitus

Post Date:

2020-01-01

Clinical Sites:

BJGMC

Publication:

International Journal of Tuberculosis and Lung Disease

IJTLD: Deshmukh and colleagues: High sensitivity and specificity of Xpert underscores need for rapid scale up for early detection of TB in settings with a high dual burden of TB and DM

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

Post Date:

2019-11-25

Publication:

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...

Lipid mediators of inflammation and resolution in individuals with tuberculosis and tuberculosis-diabetes

Post Date:

2019-11-11

Publication:

Prostaglandins and Other Lipid Mediators

Individuals with concurrent tuberculosis (TB) and Type 2 diabetes (DM) have a higher risk of adverse outcomes. To better understand potential immunological differences, we utilized a comprehensive panel to characterize pro-inflammatory and pro-resolving (i.e., mediators involved in the resolution...

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

Post Date:

2019-10-29

Countries:

India

Clinical Sites:

BJGMC

Publication:

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.

Vitamin D status and risk of incident tuberculosis disease: A nested case-control study, systematic review, and individual-participant data meta-analysis

Post Date:

2019-09-11

Publication:

PLoS Medicine

Background: Few studies have evaluated the association between preexisting vitamin D deficiency and incident tuberculosis (TB). We assessed the impact of baseline vitamins D levels on TB disease risk. Methods and findings: We assessed the association between baseline vitamin D and incident TB in a...

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

Post Date:

2019-08-15

Countries:

India

Clinical Sites:

BJGMC

Publication:

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.

High prevalence of insulin resistance and occurrence prior to hyperinsulinemia threshold among people living with HIV in Pune, India

Post Date:

2019-05-21

Countries:

India

Publication:

Diabetes Metabolic Syndrome: Clinical Research & Reviews

BACKGROUND Diabetes prevalence in HIV is not well characterized for India, despite the high burden of both individual diseases. Epidemiology of insulin resistance (IR): a precursor to diabetes, and its associated risk factors are also poorly understood in Asian Indian people living with HIV (PLHIV...

Willingness to take multidrug-resistant tuberculosis (MDR-TB) preventive therapy among adult and adolescent household contacts of MDR-TB index cases: an international multi-site cross-sectional study

Post Date:

2019-03-28

Countries:

India

Publication:

Clinical Infectious Diseases

Abstract BACKGROUND: Household contacts (HHCs) of individuals with multidrug-resistant tuberculosis (MDR-TB) are at high risk of infection and subsequent disease. There is limited evidence on the willingness of MDR-TB HHCs to take MDR-TB preventive therapy (TPT) to decrease their risk of TB disease...

Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial

Post Date:

2019-03-20

Countries:

India

Publication:

HIV Clinical Trials

BACKGROUND: IMPAACT PROMISE 1077BF/FF was a randomized study of antiretroviral therapy (ART) strategies for pregnant and postpartum women with high CD4+ T-cell counts. We describe postpartum outcomes for women in the study who were randomized to continue or discontinue ART after...

Elevated highly sensitive C-reactive protein and d-dimer levels are associated with food insecurity among people living with HIV in Pune, India

Post Date:

2019-03-04

Countries:

India

Clinical Sites:

BJGMC

Publication:

Public Health Nutrition

Abstract OBJECTIVE: To assess the prevalence and determinants of food insecurity among people living with HIV (PLWH) in Pune, India and its association with biomarkers known to confer increased risks of morbidity and mortality in this population. DESIGN:...

Is there a connection between gestational diabetes, human immunodeficiency virus infection, and tuberculosis?

Post Date:

2019-01-01

Countries:

India

Clinical Sites:

BJGMC

Publication:

International Journal of Tuberculosis and Lung Disease

IJTLD article reviews the epidemiology and immunology of gestational diabetes and finds there's a lot we don't know about interactions between diabetes, pregnancy, and tuberculosis in both HIV+/- women

Resource utilization for multidrug-resistant tuberculosis household contact investigations (A5300/I2003)

Post Date:

2018-09-01

Clinical Sites:

BJGMC

Publication:

International Journal of Tuberculosis and Lung Disease

Current guidelines recommend evaluation of the household contacts of individuals with multidrug-resistant tuberculosis; however, implementation of this policy is challenging.

Prevention of HIV-1 transmission through breastfeeding:efficacy of safety of maternal antiretroviral therapy versus infant nevirapine prophylaxis for duration of breastfeeding in HIV-1-infected women with high CD4 cell count (IMPAACT PROMISE)

Post Date:

2018-04-01

Countries:

India

Clinical Sites:

BJGMC

Publication:

Journal of Acquired Immune Deficiency Syndromes

BACKGROUND: No randomized trial has directly compared the efficacy of prolonged infant antiretroviral prophylaxis versus maternal antiretroviral therapy (mART) for prevention of mother-to-child transmission throughout the breastfeeding period. SETTING: Fourteen...

Household food insecurity is associated with low interferon-gamma levels in pregnant Indian women

Post Date:

2017-07-01

Countries:

India

Clinical Sites:

BJGMC

Publication:

International Journal of Tuberculosis and Lung Disease

Objective: To determine the association between household food insecurity and interferon-gamma (IFN-γ) levels in pregnancy. Design: Pregnant women in India were administered the Household Food Insecurity Access Scale (HFIAS) questionnaire and underwent an IFN-γ release assay...

Cost effectiveness of isoniazid preventive therapy for HIV-infected pregnant women in India

Post Date:

2016-01-01

Countries:

India

Clinical Sites:

BJGMC

Publication:

International Journal of Tuberculosis and Lung Disease

Background: India has a high burden of active tuberculosis (TB) and human immunodeficiency virus (HIV) infection. Pregnancy increases the risks of developing TB in HIV-infected women. Isoniazid preventive therapy (IPT) reduces progression to TB, but may increase costs and hepatotoxicity. The...

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