Clinical Research

Clinical Sites:

This study ended in April 2013. This was a review and collection of data from the medical records of pediatric patients who were admitted to the BJMC/Sassoon General Hospitals with H1N1 influenza during August-November 2009.

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

Post Date:

2010-02-02

Countries:

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...

P1077FF: Formula Feeding Version of the PROMISE Study (Promoting Maternal and Infant Survival Everywhere)

Post Date:

2010-02-02

Countries:

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

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

Post Date:

2009-04-22

Countries:

Clinical Sites:

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

Post Date:

2009-04-02

Countries:

Clinical Sites:

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...

Evaluation of the Impact of Distance Learning For Expanding Capacity for Clinical Research in India

Post Date:

2009-02-13

Countries:

This study ended in March 2012. The Office of AIDS Research has initiated a comprehensive program to expand clinical research capacity in India. This program has utilized a number of platforms for providing research training, including intensive in-country workshops and conferences. These programs...

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

Countries:

Clinical Sites:

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...

The Presentation and Disease Progression of HIV Infection Among Indian Children

Post Date:

2008-09-22

Countries:

This study was terminated July 24, 2010.

Calibration and Application of a Simple Sensitive/Less Sensitive Assay Applicable to Resource-Limited Countries for Determination of Recent HIV Infection and Incidence Estimates

Post Date:

2007-03-22

Countries:

United States

This study was terminated March 31, 2007. Sensitive/Less Sensitive assays (S/LS) to distinguish between recent and established HIV infections have been successfully applied to identify recently infected persons and determine HIV incidence. However, all currently used S/LS assays require laboratory...

BWI CTU: Baltimore-Washington-India Clinical Trials Unit

Post Date:

2007-02-02

Countries:

United States

Clinical Sites:

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...

BJGMC-JHU Fogarty HIV-TB Training Program

Post Date:

2007-01-01

Countries:

Clinical Sites:

Funded by the Fogarty International Center at the National Institutes of Health, the JHU Fogarty program has nearly 20 years of success with providing training, professional development, and mentorship to clinicians and scientists in low and middle income countries. CCGHE's latest efforts in...

P1060: Phase II, parallel, randomized, clinical trials comparing the responses to initiation of NNRTI-based antiretroviral therapy in HIV-infected infants who have not previously received Single dose Nevirapine for prevention of Mother-to-child HIV...

Post Date:

2006-03-27

Countries:

Clinical Sites:

This study ended June 28, 2015. This multi-country trial was conducted in India, Malawi, 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 Health...

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

Countries:

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...

Predictors of Antiretroviral Adherence, Plasma HIV RNA Levels and Antiretroviral Resistance Among Patients with HIV Attending Private Clinics in Mumbai, India

Post Date:

2004-12-02

Countries:

This study was terminated November 16, 2006.

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

Post Date:

2004-07-27

Countries:

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...

Evaluation of Provider, Patient and Pharmacy Knowledge, Attitudes and Practices Regarding HIV Care and Use of Antiretroviral Therapy in Pune, India

Post Date:

2004-03-29

Countries:

This study ended in 2007. Antiretroviral therapy (ART) has dramatically affected morbidity and mortality among HIV-infected persons in industrialized countries. In India, where approximately 4.3 million persons are estimated to be HIV-infected (NACO), the use of ART has been limited because of the...

A Study to Validate New Assays for Measuring HIV Seroincidence in Indian HIV Subtype C Seroconverters

Post Date:

2003-08-05

Countries:

This study ended in July 2006.

Mother-to-Child Transmission (MTCT) of HIV: India SWEN Study

Post Date:

2002-06-07

Countries:

Clinical Sites:

This study was officially terminated August 2018. Primary and secondary analyses of the India SWEN study, an NIH-funded phase III randomized controlled trial of an extended nevirapine prophylaxis regimen among 783 HIV-infected pregnant women and their...

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

Post Date:

2020-01-01

Clinical Sites:

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

Addressing the global burden of hepatitis B virus while developing long-acting injectables for the prevention and treatment of HIV

Post Date:

2019-12-20

Publication:

Lancet HIV

Lancet HIV: Dr. Bob Bollinger and colleagues discuss the urgent need and opportunity to include activity against Hepatitis B in formulations of long-acting drugs for HIV prevention and treatment

Transcriptomic profiles of confirmed pediatric tuberculosis patients and household contacts identifies active tuberculosis, infection, and treatment response among Indian children

Post Date:

2019-12-04

Clinical Sites:

Publication:

Journal of Infectious Diseases

Journal of Infectious Diseases: Gene expression profiles among Indian children with confirmed TB were distinct from those of adults, highlighting the importance of including distinct populations in differential gene expression models

Evaluating the Concordance of Clinician Antiretroviral Prescribing Practices and HIV-ASSIST, an Online Clinical Decision Support Tool

Post Date:

2019-12-02

Countries:

Publication:

Journal of General Internal Medicine

Recent studies have shown that more than half of HIV care is provided by primary care practitioners.However, clinicians with experience and expertise in HIV medicine are declining.

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:

Clinical Sites:

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.

Isoniazid Preventive Therapy and Pregnancy Outcomes in Women Living With Human Immunodeficiency Virus in the Tshepiso Cohort

Post Date:

2019-10-21

Publication:

Clinical Infectious Disease

Background Both pregnancy and human immunodeficiency virus (HIV) increase the risk of tuberculosis disease, which results in poor maternal, pregnancy, and infant outcomes. Isoniazid preventive therapy (IPT) reduces mortality among individuals living with HIV in high-burden settings but has recently...

Isoniazid preventive therapy in HIV-infected pregnant and postpartum women

Post Date:

2019-10-03

Countries:

Clinical Sites:

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.

Delays and barriers to early treatment initiation for childhood tuberculosis in India

Post Date:

2019-10-01

Publication:

International Journal of Tuberculosis and Lung Disease

BACKGROUND: India accounts for 27% of global childhood tuberculosis (TB) burden. Understanding barriers to early diagnosis and treatment in children may improve care and outcomes. METHODS: A cross-sectional study was performed among 89 children initiated on anti-TB treatment from a public hospital...

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

Post Date:

2019-10-01

Countries:

United States

Publication:

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...

Challenges in conducting trials for pediatric tuberculosis meningitis: lessons learned in the field

Post Date:

2019-10-01

Countries:

Clinical Sites:

Publication:

International Journal of Tuberculosis and Lung Disease

International Journal of Tuberculosis and Lung Disease: Researchers describe the challenges associated with conducting the first randomized clinical trial of antimicrobial agents in pediatric tuberculosis meningitis.

Delamanid central nervous system pharmacokinetics in tuberculous meningitis in rabbits and humans

Post Date:

2019-09-23

Clinical Sites:

Hinduja Hospital

Publication:

Antimicrobial Agents and Chemotherapy

Central nervous system tuberculosis (TB) is devastating and affects vulnerable populations. Multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculous meningitis (TBM) specifically are nearly uniformly fatal, with little information being available to guide the treatment of...

Re: A Shorter Regimen for Rifampin-Resistant Tuberculosis

Post Date:

2019-09-12

Countries:

Clinical Sites:

Hinduja Hospital

Publication:

New England Journal of Medicine

Dr. Jeff Tornheim and colleagues respond to an NEJM article about shorter course TB treatment.

Use of smartphone-based video Directly Observed Therapy (vDOT) in tuberculosis care: Single-arm, prospective feasibility study

Post Date:

2019-08-30

Countries:

Clinical Sites:

DY Patil

Publication:

Journal of Medical Internet Research

Video-based monitoring is increasingly used as an efficient and low cost alternative to in-person observation and monitoring of TB patients. It showed promise in the high TB setting of India, too.

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:

Clinical Sites:

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.

A tuberculosis-free world: is it a delusion?

Post Date:

2019-08-12

Publication:

The Lancet

The Lancet: Dr. Sachin Atre's correspondence questions progress and global commitment toward TB elimination.

Smoking, alcohol use disorder and tuberculosis treatment outcomes: A dual co-morbidity burden that cannot be ignored

Post Date:

2019-07-31

Countries:

Clinical Sites:

Publication:

PLoS One

BACKGROUND: More than 20% of tuberculosis (TB) disease worldwide may be attributable to smoking and alcohol abuse. India is the second largest consumer of tobacco products, a major consumer of alcohol particularly among males, and has the highest burden of TB globally. The impact of...

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

Post Date:

2019-07-29

Countries:

Clinical Sites:

Publication:

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...

Infection free "resisters" among household contacts of adult pulmonary tuberculosis

Post Date:

2019-07-18

Countries:

Clinical Sites: