Clinical Research

Clinical Sites:

Dr. Vidya Mave is leading this clinical trial evaluating the safety and efficacy of a new recombinant BCG vaccine.

Perceptions of HCWs on Barriers and Opportunities to Airborne Infection Control Guideline Implementation

Post Date:

2017-12-07

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This study is funded and conducted under the U.S. National Institutes of Health, Fogarty International Center. Led by Dr. Nishi Suryavanshi, this qualitative, cross-sectional study is assessing healthcare worker (HCW) perceptions about barriers and facilitators to the uptake of airborne infection...

Building on Needle Exchange to Optimize HIV Prevention/Treatment

Post Date:

2017-12-01

Countries:

Biomedical interventions that have direct applicability to people who inject drugs (PWID) have flourished over the past 15 years (HIV treatment as prevention, pre-exposure prophylaxis, office-based medication-assisted treatment (MAT) with buprenorphine, and hepatitis C virus (HCV) treatment with...

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

Post Date:

2017-11-21

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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. A5302 is a multi-center trial of the AIDS Clinical Trials Group (ACTG) in collaboration with the Tuberculosis Trials Consortium (TBTC).This study will be conducted at the BJ...

The Role of GeneXpert in Bacterial Diagnosis of Spinal Tuberculosis

Post Date:

2017-10-26

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This study was teriminated June 19, 2019. It was funded by the Fogarty International Center at the U.S. National Institutes of Health. India has the maximum burden of tuberculosis (TB) in the world. In 2014, there were an estimated 9.6 million incident cases of TB (range, 9.1 million–10.0 million)...

Assessment of Cardiovascular Health Knowledge, Preventive Practices and Cardio-protective Behavior among HIV-infected Individuals in Pune, India

Post Date:

2017-10-12

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This study is conducted under the TREAT Asia Network and funded by amfAR. Cardiovascular Diseases (CVD) have become one of the leading causes of death among PLWH (People Living with HIV) across the globe. The burden that CVD will pose in the imminent future for the 2.1 million HIV-infected...

Lipid Mediators of Inflammation in TB and TB-Diabetes

Post Date:

2017-10-02

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This study was terminated August 1, 2019. It was funded and conducted under the U.S. National Institutes of Health and is nested within Impact of Diabetes on TB Treatment Outcomes. Dr. Jonathan Golub was the PI. Studies have shown that individuals with Tuberculosis (TB) and diabetes (TB-DM) have a...

HIV Antiretroviral Selection Support and Interactive Search Tool (ASSIST)

Post Date:

2017-09-01

HIV-ASSIST is an evidence based, web platform designed and developed by experts at Johns Hopkins University to assist and educate clinicians in personalizing ARV regimens for their patients. This tool is designed to be used for adult patients only. The goals are to provide: Patient-centric...

Zika Surveillance among Antenatal Clinic Outpatients in BJ Government Medical College and Sassoon General Hospitals, Pune, India

Post Date:

2017-08-31

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This study was terminated July 21, 2020. Zika virus is a vector-borne disease carried by the mosquito Aedes aegypti . Pregnant women infected with Zika may pass the virus to the fetus, which may cause microcephaly and other severe brain defects. It is also linked to miscarriage, stillbirth, and...

Investigating Maternal Antibodies to Modify Infant Tuberculosis Acquisition

Post Date:

2017-08-29

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New study in Pune, India, aims to identify the profile of TB antibodies between mothers and infants, and to see if the presence of antibodies lowers risk of infant infection.

The Role of Innate Immunity in the Acquisition of Sterile Protection against TB Infection

Post Date:

2017-08-25

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This study is using stored samples from the Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH), under the Regional Prospective Observational Research for Tuberculosis (RePORT) Network, an international TB consortium. Tuberculosis (TB) is a major global health problem...

Validation of Transcriptional Signature to Predict Active TB Disease among Advanced HIV Patients

Post Date:

2017-08-15

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There have been tremendous advances in the diagnosis of patients with tuberculosis (TB) based on nucleic acid amplification of bacteria in the sputum. The GenXpert MTB/RIF provides results in 2 hours. However, in HIV-infected sputum smear is often negative for AFB and the sensitivity of GenXpert...

Antimicrobial Use and Diagnosis among Hospitalized Febrile Patients in Pune, India

Post Date:

2017-08-07

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Antimicrobial resistance, a leading threat to human health, is enabled by unnecessary antibiotic use. Strategies to reduce unnecessary antibiotic use in India, the world’s largest antibiotic consumer, are urgently needed. Although most patients hospitalized in India with acute febrile illness...

Association of Lipid Mediators of Inflammation with TB Treatment Outcomes

Post Date:

2017-08-03

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Clinical Sites:

This study was terminated July 22, 2019. This study used stored samples from the Cohort for Tuberculosis Research by the Indo-US Medical Partnership (C-TRIUMPH), under the Regional Prospective Observational Research for Tuberculosis (RePORT) Network, an international TB consortium. Recent studies...

Role of Specialized Pro-resolving Mediators (SPMs) on Markers of Inflammation in HIV-infected Adults

Post Date:

2017-08-03

Countries:

Dr. Rupak Shivikoti is leading this study. There has been a surge of recent studies focusing on the role of novel lipid mediators of inflammation called specialized pro-resolving mediators (SPMs). They are produced during inflammation as a negative feedback to resolve inflammation. However, the...

Optimizing Treatment to Improve TBM Outcomes in Children: Substudy on Clinical Profile and CSF Biorepository of the Pediatric Suspected Meningitis Cases

Post Date:

2017-07-18

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This sub-study is being led by PIs Dr. Kelly Dooley and Dr. Chhaya Valvi. Meningoencephalitis is associated with significant morbidity and mortality. Several viruses, bacteria, and fungal pathogens including Neisseria meningitidis, Streptococcus pneumoniae, Mycobacterium tuberculosis, Herpes...

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

Post Date:

2017-06-09

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Clinical Sites:

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 for up to 72 months...

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

Post Date:

2017-06-05

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Clinical Sites:

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-...

Understanding Quality of Life during and Loss to Follow-up from Drug-Resistant Tuberculosis Treatment in Pune, India

Post Date:

2017-05-15

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This study will examine a) risk factors for loss to follow-up from DR-TB treatment, b) actively trace DR-TB patients lost to follow-up from treatment and c) establish a prospective observational cohort of MDR-TB, XDR-TB and DS-TB patients as well as healthy controls nested within ongoing RNTCP...

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

Post Date:

2019-07-18

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Clinical Sites:

Publication:

PLoS One

Despite substantial exposure to infectious pulmonary tuberculosis (TB) cases, some household contacts (HHC) never acquire latent TB infection (LTBI). Characterizing these "resisters" can inform who to study immunologically for the development of TB vaccines. We enrolled HHCs of culture-...

HIV-ASSIST

Post Date:

2019-07-16

Publication:

HIVSpecialist

HIVSpecialist: Dr. Maunank Shah and colleagues chronicle the development of HIV-ASSIST, a tool to help guide selections for patient-centered antiretroviral therapy.

Advancing the development of new tuberculosis treatment regimens: The essential role of translational and clinical pharmacology and microbiology

Post Date:

2019-07-15

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Publication:

PLoS Medicine

Summary points Translational and clinical pharmacology are the state-of-the-art tools used by drug developers to efficiently move compounds and regimens through all drug development phases. Tuberculosis drug and regimen development, though, has traditionally underutilized these modern, model-based...

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

Publication:

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

Advancing the development of new tuberculosis treatment regimens: The essential role of translational and clinical pharmacology and microbiology

Post Date:

2019-07-05

Countries:

Publication:

PLOS

Application of clinical pharmacology best practices is essential to the efficient and rational development of drugs. In general, knowledge gained about exposure–response relationships in preclinical models aids drug and dose selection in human studies, and biomarkers and pharmacokinetic (PK) data...

Mobile phone access and comfort: implications for HIV and tuberculosis care in India and South Africa.

Post Date:

2019-07-01

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Publication:

International Journal of Tuberculosis and Lung Disease

SETTING: India and South Africa shoulder the greatest burden of tuberculosis (TB) and human immunodeficiency virus (HIV) infection respectively, but care retention is suboptimal. OBJECTIVE: We conducted a study in Pune, India, and Matlosana, South Africa ...

Advancing Patient-Centered Care in Tuberculosis Management: A Mixed-Methods Appraisal of Video Directly Observed Therapy

Post Date:

2019-06-25

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Publication:

Open Forum Infectious Diseases

OFID : Study compared directly-observed therapy with video-based observed therapy using the emocha mobile health platform

Age-specific prevalence of TB infection among household contacts of pulmonary tuberculosis: Is it time for TB preventive therapy?

Post Date:

2019-06-21

Countries:

Publication:

Transactions of the Royal Society of Tropical Medicine and Hygiene

BACKGROUND: Household contacts (HHCs) of TB patients are at high risk of developing evidence of latent TB infection (LTBI) and active disease from the index patient. We estimated the age-specific prevalence of LTBI and the force of infection (FI), as a measure of recent transmission, among HHCs of...

Users beware! Biological variation in complete blood counts over short time intervals

Post Date:

2019-05-29

Publication:

BMJ Evidence Based Medicine

New publication in BMJ Evidence Based Medicine looks at CBC count variations in blood drawn over a short time period

Assessment of lung function in successfully treated tuberculosis reveals high burden of ventilatory defects and COPD

Post Date:

2019-05-23

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Publication:

PLoS One

New in PLoS One: We found a high burden of lung function defects and COPD in tuberculosis cases who successfully completed treatment, suggesting a need for lung function screening as part of patient management.

Subtherapeutic rifampicin concentration is associated with unfavourable tuberculosis treatment outcomes

Post Date:

2019-05-10

Countries:

Publication:

Clinical Infectious Diseases

Rifampicin concentrations were sub-therapeutic in most Indian patients taking a thrice-weekly TB regimen

Venezuela's Public Health Crisis: A Regional Emergency

Post Date:

2019-04-11

Countries:

Venezuela

Publication:

Lancet

The Lancet: The economic crisis in Venezuela has eroded the country's health-care infrastructure and threatened public health.

The burden of diabetes in India

Post Date:

2019-04-01

Countries:

Publication:

The Lancet Global Health

The India State-Level Disease Burden Initiative Diabetes Collaborators (December, 2018)1 provide a comprehensive overview of the diabetes burden in India. The authors point out some limitations in estimates due to inadequacies in the data. Nevertheless, on the basis of my field experience in India...

A population pharmacokinetic analysis shows that arylacetamide deacetylase (AADAC) gene polymorphism and HIV infection affect the exposure of rifapentine

Post Date:

2019-03-29

Countries:

Publication:

Antimicrobial Agents Chemotherapy

New analysis published in Antimicrobial Agents and Chemotherapy!

Feasibility of identifying household contacts of rifampin- and multidrug-resistant tuberculosis cases at high risk of progression to tuberculosis disease

Post Date:

2019-03-28

Countries:

Publication:

Clinical Infectious Diseases

We assessed multidrug-resistant tuberculosis (MDR-TB) cases and their household contacts (HHCs) to inform the development of an interventional clinical trial.

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:

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...

Building the framework for standardized clinical laboratory reporting of next generation sequencing data for resistance-associated mutations in Mycobacterium tuberculosis complex

Post Date:

2019-03-18

Publication:

Clinical Infectious Diseases

Abstract Tuberculosis is the primary infectious disease killer worldwide, with a growing threat from multidrug- resistant cases. Unfortunately, classic growth-based phenotypic drug susceptibility testing (DST) remains difficult, costly and time-consuming, while current rapid molecular testing...

Evaluation of an adapted Project Connect community based intervention among professionals serving young minority men

Post Date:

2019-03-15

Countries:

Publication:

Sexually Transmitted Diseases

BACKGROUND: To address sexual and reproductive health (SRH) needs of young minority urban males, we developed and evaluated Project Connect Baltimore (Connect), which was adapted from a program with demonstrated effectiveness among young females. The objectives were to determine (1) the...

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!

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

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Clinical Sites:

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:...

Perinatal Depression among HIV and TB Infected and Uninfected Women in an Urban Slum in India: Prevalence and Associated Birth Outcomes

Post Date:

2018-10-04

Countries:

Clinical Sites:

Grossman TB , Bhosale R, Alexander M, Suryavanshi N, Mave V, Jain D, Patil NU, Gupta A, Mathad JS. Perinatal depression among HIV and TB infected and uninfected women in an urban slum in India: prevalence and associated birth outcomes. IDSA. ID Week 2018. San Francisco, CA. October 3-7, 2018.

Antibiotic Use and Drug-Resistant Late-Onset Infections Among Neonates Admitted to Neonatal Intensive Care Units in Pune, India

Post Date:

2018-08-28

Countries:

Clinical Sites:

Agarkhedkar S, Armstrong D, Bharadwaj R, Cox SR, Dohe V, Gupta A, Gupte N, Johnson J, Kadam A, Kinikar A, Malwade S, Manabe Y, Mave V, Milstone A, Parikh T, Rajput U, Randive B, Robinson M , Smith R, Suryavanshi N, Vaidya U, Westercamp M. Antibiotic Use and Drug-Resistant Late-Onset Infections...

High Prevalence of Dengue among Pregnant Women in India

Post Date:

2018-08-27

Countries:

Clinical Sites:

Alexander M, Naik S, Robinson M , Sapkal G, Deshpande P, Kulkarni V, Nimkar S, Sambarey P, Kinikar A, Mave V, Suryavanshi N, Gupte N, Bollinger R, Gupta A, Bharadwaj R, Mathad J. High Prevalence of Dengue among Pregnant Women in India. 2018 International Conference on Emerging Infectious Diseases...

Association of Maternal Viral Load and CD4 Count with Perinatal HIV-1 Transmission Risk during Breastfeeding in the PROMISE Postpartum Component

Post Date:

2018-07-26

Countries:

Clinical Sites:

Flynn P, Taha T, Cababasay M, Butler K, Fowler MG, Mofenson L, Owor M, Fiscus S, Stranix-Chibanda L, Coutsoudis A, Gnanshanmugam D, Chakhtoura N, McCarthy K, Mukuzunga C, Makanani B, Moodley D, Nematadzira T, Kusakara B, Patil S, Vhembo T, Bobat R, Mmbaga B, Masenya M, Nyati M, Theron G, Mulenga H...

Mobile Health and Behavioral PMTCT Intervention among Community Health Workers Improves Exclusive Breastfeeding and Early Infant Diagnosis in India: A Cluster Randomized Trial

Post Date:

2018-07-24

Countries:

Clinical Sites:

Suryavanshi N, Kadam A, Hegde A, Sivalenka S, Kumar VS, McKenzie-White J, Kanade S, Gupta A, Bollinger RC, Shankar A, Gupte N, Mave V. Mobile Health and Behavioral PMTCT Intervention among Community Health Workers Improves Exclusive Breastfeeding and Early Infant Diagnosis in India: A Cluster...

Opportunities, Challenges and Implications of m-Health Oral Cancer Screening for HIV-positive Individuals in India

Post Date:

2018-07-23

Countries:

Clinical Sites:

Joshi S, Chandanwale A, Sangle S, Marbaniang I , Khaire S, Thakur R, Gupta A, Chigurupati R, Mave V. Opportunities, Challenges and Implications of m-Health Oral Cancer Screening for HIV-positive Individuals in India. AIDS 2018. Amsterdam, The Netherlands. July 23-27, 2018.

Health-related Quality of Life in the A5274 Trial of TB Therapy in Advanced HIV

Post Date:

2018-07-22

Clinical Sites:

Lando R, Sun X, Miyahara S, Hosseinpour MC, Bisson GP, Kumwenda J, Gupta A, Nyirenda M, Katendey K, Torres TS, Suryavanshi N, Beulah F, Opollo V, Shah NS on behalf of the A5274 study team. Health-related Quality of Life in the A5274 Trial of TB Therapy in Advanced HIV. TB 2018, Amsterdam, The...

Role of Maternal Viral Load and CD4 Count on Perinatal HIV-1 Transmission during Breastfeeding in the PROMISE Postpartum Component

Post Date:

2018-07-20

Clinical Sites:

Flynn P, Taha T, Cababasay M, Butler K, Fowler MG, Mofenson L, Owor M, Fiscus S, Stranix-Chibanda L, Coutsoudis A, Gnanshanmugam D, Chakhtoura N, McCarthy K, Mukuzunga C, Makanani B, Moodley D, Nematadzira T, Kusakara B, Patil S , Vhembo T, Bobat R, Mmbaga B, Masenya M, Nyati M, Theron G, Mulenga H...

Association between Dietary Intake and the Composition of the Vaginal Microbiota

Post Date:

2018-06-20

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Clinical Sites:

Shivakoti R , Tuddenham S, Caulfield LE, Robinson C, Rave J, Ghanem K, Brotman R. Association between dietary intake and the composition of the vaginal microbiota. Society for Epidemiologic Research 51st Annual Meeting. Baltimore, MD. June 19-22, 2018.

Association between Dietary Intake and the Composition of the Vaginal Microbiota

Post Date:

2018-06-09

Countries:

Clinical Sites:

Shivakoti R , Tuddenham S, Caulfield LE, Robinson C, Rave J, Ghanem K, Brotman R. Association between Dietary Intake and the Composition of the Vaginal Microbiota. Oral presentation at Nutrition 2018 Conference. American Society for Nutrition. Boston, MA. June 9, 2018.

Bloodstream Infections among Neonates Admitted to Neonatal Intensive Care Units in Pune, India

Post Date:

2018-05-05

Countries:

Clinical Sites:

DY Patil

Johnson J , Rajput U, Valvi C, Bharadwaj R, Parikh T, Agarkhedkar S, Robinson M, Randive B, Gupte N, Smith R, Westercamp M, Mave V, Manabe Y, Milstone A, for the CDC SHEPheRD India Study Team. Bloodstream Infections among Neonates Admitted to Neonatal Intensive Care Units in Pune, India. Pediatric...

Importance of Diagnosis of TB Infection in Pregnant Women in India: Findings from a Cohort Study in Pune, India

Post Date:

2018-04-24

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Clinical Sites:

Mathad J. Importance of Diagnosis of TB Infection in Pregnant Women in India: Findings from a Cohort Study in Pune, India. Oral Presentation. Presented at Global Health Research Initiative’s Scientific Conference, Weill Cornell Medical College, April 24, 2018.

Linezolid Experience Among MDR-TB Patients in Mumbai

Post Date:

2018-03-16

Countries:

Clinical Sites:

Hinduja Hospital

Tornheim J. Linezolid Experience Among MDR-TB Patients in Mumbai. 2018 Research Retreat, Johns Hopkins Department of Medicine. Baltimore, MD. 2018.

Similar Clinical Outcomes Between Formula and Breastfeeding Women In PROMISE

Post Date:

2018-03-07

Countries:

Clinical Sites:

Hoffman RM , Angelidou K, Brummel S, Saidi F, Dula DE, Mave V, Fairlie L, Theron G, Kamateeka M, Chipato T, Violari A, Chakhtoura N, Currier JS, Fowler MG, for the IMPAACT PROMISE 1077BF/FF Team. Similar Clinical Outcomes Between Formula and Breastfeeding Women In PROMISE. CROI 2018. Boston,...

Randomized Trial of Safety of Isoniazid Preventive Therapy During or After Pregnancy

Post Date:

2018-03-07

Clinical Sites:

Gupta A, Montepiedra G, Aaron L, Theron G, McCarthy K, Onyango-Makumbi C, Chipate T, Masheto G, Shin K, Zimmer B, Sterling TR, Chakhtoura N, Jean-Philippe P, Weinberg A for the IMPAACT P1078/TB APPRISE Study Team. Randomized Trial of Safety of Isoniazid Preventive Therapy During or After Pregnancy...

GLP-1 and C-Peptide are Associated with Insulin Resistance among PLWH in India

Post Date:

2018-03-07

Countries:

Clinical Sites:

Marbaniang I, Sangle S, Kadam D, Kulkarni V, Shere D, Gupte N, Gupta A, Mave V. GLP-1 and C-Peptide are Associated with Insulin Resistance among PLWH in India. CROI 2018. Boston, MA. 2018

Inflammation in HIV-Infected Pregnant Women is Associated with Pre-term Birth

Post Date:

2018-03-07

Countries:

Clinical Sites:

Shivakoti R , Gupte N, Kumar NP, Kulkarni V, Balasubramanian U, Bhosale R, Sambarey P, Kinikar A, Bharadwaj R, Patil S, Inamdar S, Suryavanshi N, Babu S, Bollinger R, Gupta A. Inflammation in HIV-Infected Pregnant Women is Associated with Pre-term Birth. CROI 2018. Boston, MA. 2018

One Month of Rifapentine/Isoniazid to Prevent TB In People With HIV: Brief-TB/A5279

Post Date:

2018-03-05

Countries:

Clinical Sites:

Swindells S, Ramchandani R, Gupta A, Benson CA, Leon-Cruz JT, Omoz-Oarhe A, Juste MAJ, Lama JR, Valencia JA, Badal-Faesen S, Moran LE, Fletcher CV, Nuermberger E, Chaisson RE. One Month of Rifapentine/Isoniazid to Prevent TB In People With HIV: Brief-TB/A5279. CROI 2018. Boston, MA. 2018

Infection Free “Resistors” among Household Contacts of Culture-Confirmed Adult Pulmonary TB Cases

Post Date:

2018-02-21

Countries:

Clinical Sites:

Hinduja Hospital

Mave V , Chandrasekaran P, Paradkar M, Gupte A, Pradhan N, Kannan GN, Shivakumar SVBY, Kulkarni V, Dhanasekaran K, Subramanyam B, Selvaraju S, Murali L, Bharadwaj R, Gaikwad S, Meshram S, Kinikar A, Hanna LE, Swaminathan S, Gupte N, Gupta A. Infection Free “Resistors” among Household Contacts of...

TB Infection Among Household Contacts: Preventive Therapy for All?

Post Date:

2018-02-21

Countries:

Clinical Sites: