Antiretroviral therapy

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...

Impact of Tuberculosis Infection on HIV-1 Antibody Response (NWCS501)

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2020-12-05
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Study Objective: Compare longitudinal HIV-1 antibody responses among HIV-1 infected participants that either did or did not develop active TB enrolled in ACTG 5274 and ACTG 5279 Study Design: Longitudinal antibody responses will be examined among select participants in A5274 who have plasma samples...

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 impairment compared to the 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 patients living with HIV compared with 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 patients living with HIV compared with TB...

Management of Multidrug-resistant Tuberculosis among ART Programs in Low- and Middle-income Countries within the Global IeDEA Network

Post Date: 
2019-07-22
Purpose The purpose of the IeDEA MDR-TB survey is to study the clinical management of HIV patients co-infected with MDR-TB or XDR-TB from the perspective of healthcare workers in ART programs participating in the IeDEA global cohort consortium. Specifically, we aim: to describe diagnostic, referral...

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 “VESTED”: V irologic E fficacy and S afety of...

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

Post Date: 
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

Post Date: 
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

Post Date: 
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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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. We...

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...

BJGMC-JHU Fogarty HIV-TB Training Program

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2007-01-01
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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 this...

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

Post Date: 
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

Post Date: 
2020-03-23
Publication: 
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

Post Date: 
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
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...

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

Post Date: 
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

Post Date: 
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.

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
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

Symptom screening for active tuberculosis in pregnant women living with HIV

Post Date: 
2019-01-24
Publication: 
Cochrane Database of Systematic Reviews
This is a protocol for a Cochrane Review (Diagnostic test accuracy). The objectives are as follows: To assess the accuracy of the four-symptom screen (cough, fever, night sweats, or weight loss) for identifying active TB in pregnant PLHIV who are screened in an outpatient or community setting...

Inflammation and micronutrient biomarkers predict clinical HIV treatment failure and incident active TB in HIV-infected adults: a case-control study

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2018-09-24
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BMC Medicine
Factors identified through exploratory factor analysis were associated with adverse outcomes in HIV-infected individuals.

Challenges of TB and co-treatment: updates and insights

Post Date: 
2018-08-04
Publication: 
Current Opinion in HIV and AIDS
PURPOSE OF REVIEW: In the past few years, tuberculosis (TB) has overtaken HIV as the infectious disease with the highest global mortality. Successful management of this syndemic will require improved diagnostic tests, shorter preventive therapies, and more effective treatments,...

Loss to follow‐up and mortality among HIV‐infected adolescents receiving antiretroviral therapy in Pune, India

Post Date: 
2018-06-25
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HIV Medicine
Over 6 years, one-third of HIV+ adolescents in this study discontinued medical treatment, indicating a critical need for retention counselling and closer clinical monitoring.

Hepatotoxicity during isoniazid preventive therapy and antiretroviral therapy in people living with HIV with severe immunosuppression: a secondary analysis of a multi-country open-label randomized controlled clinical trial

Post Date: 
2018-05-01
Publication: 
Journal of Acquired Immune Deficiency Syndromes
BACKGROUND: Hepatotoxicity associated with isoniazid preventive therapy (IPT) and antiretroviral therapy (ART) has not been well studied in severely immunosuppressed people with HIV. Our objective was to determine risk factors for hepatotoxicity in severely immunosuppressed individuals...

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
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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...

Intestinal barrier dysfunction and microbial translocation in HIV-infected pregnant women is associated with preterm birth

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2018-03-24
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Clinical Infectious Diseases
Our results show select immune markers can identify women at higher risk for PTB in HIV-1-infected populations and suggest modulating gut barrier integrity and microbial translocation may affect PTB.

Risk factors for early mortality on antiretroviral therapy in advanced HIV-infected adults

Post Date: 
2017-10-23
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AIDS
Background: Many HIV-infected individuals present with advanced HIV disease. These patients are at high risk of death after antiretroviral therapy (ART) initiation, but risk factors for death in these patients are unclear. Methods: We used data from a multisite randomized trial...

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

Post Date: 
2017-07-01
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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 therapy (ART) initiation in HIV-infected individuals is not well characterized...

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. ...

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Risk Factors for Hepatotoxicity in HIV-infected Women Receiving Isoniazid preventive Therapy in Pregnancy and Postpartum

Post Date: 
2020-07-08
Gupta A, Aaron L, Theron G, McCarthy K, Bradford S, Chipato T,

Adjusted analysis of effect of IPT on adverse pregnancy outcomes in women with HIV

Post Date: 
2020-03-09
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Theron G , Chakhtoura N, Montepiedra G, Aaron L, Jean-Phillipe P, Weinberg A, McCarthy K, Nematadzira T, Masheto G, Chipato T, Onyango-Makumbi C, Gupta A, the IMPAACTP1078 Team. Adjusted analysis of effect of IPT on adverse pregnancy outcomes in women with HIV. Presented at: CROI 2020. Boston,...

Tuberculosis infection and inflammation among HIV-infected adults in India

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2019-10-31
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Kulkarni V . Tuberculosis infection and inflammation among HIV-infected adults in India. Oral Presentation. 50th Union World Conference on Lung Health. Hyderabad, India. October 30-November 2, 2019.

Preventing tuberculosis in people with HIV infection

Post Date: 
2019-03-06
Gupta A. Choices and dilemmas: Preventing tuberculosis in people with HIV infection. Coinfections: Tuberculosis, Hepatitis B and C, and HIV Symposium. CROI 2019. Seattle, Washington. March 4-7, 2019.

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
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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

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2018-07-24
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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...

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

Post Date: 
2018-07-22
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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
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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...

Similar Clinical Outcomes Between Formula and Breastfeeding Women In PROMISE

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2018-03-07
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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,...

Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens

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2017-07-26
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Bhattacharya D , Gupta A, Tierney C, Huang S, Peters M, Chipato T, Martinson F, Dula D, George K, Chaktoura N, Klingman K, Gnanashanmugam D, Currier J, Fowler MG. Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens. IAS 2017. International AIDS Society. Paris, France...

Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens in PROMISE P1077

Post Date: 
2017-05-31
Amita Gupta. Hepatotoxicity in HIV+ Postpartum Women Initiating Efavirenz-Containing Regimens in PROMISE P1077. 2017 IMPAACT Annual Meeting. Washington, DC. 2017

IMPAACT 2001: Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-infected and HIV-1-uninfected Pregnant and Postpartum Women with Latent Tuberculosis Infection

Post Date: 
2017-05-30
Jyoti Mathad. IMPAACT 2001: Trial of the Pharmacokinetics, Tolerability, and Safety of Once-Weekly Rifapentine and Isoniazid in HIV-infected and HIV-1-uninfected Pregnant and Postpartum Women with Latent Tuberculosis Infection. 2017 IMPAACT Annual Meeting. Washington, DC. 2017.

Hepatotoxicity in People with Advanced Immunosuppression taking Isoniazid Preventive Therapy and Antiretroviral Therapy

Post Date: 
2017-02-14
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Ngongondo M , Miyahara S, Hughes MD, Sun X, Gupta A, Kumwenda J, Torres TS, Bisson G, Hosseinipour MC. Hepatotoxicity in People with Advanced Immunosuppression taking Isoniazid Preventive Therapy and Antiretroviral Therapy. CROI 2017. Seattle, Washington. 2017.

Presentation, Etiology, and Outcome of Febrile Indian Patients Differs by HIV Status

Post Date: 
2016-11-16
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Kadam D, Robinson M , Kagal A, Bharadwaj R, Raichur P, Kanade S, Sachs J, Gupte N, Gupta A, Mave V. Presentation, Etiology, and Outcome of Febrile Indian Patients Differs by HIV Status. 65th Annual Meeting, American Society of Tropical Medicine and Hygiene. Atlanta, GA.

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

Post Date: 
2016-06-10
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Shivakoti, R. Inflammation in HIV-infected Pregnant Women: Relationship with Diet, Gut Microbiome, and Preterm Birth. JHU Center for AIDS Research Annual Meeting. Baltimore, MD.

Best Practices in Antiretroviral Therapy: Managing Antiretroviral Therapy in HIV-Infected Patients with Viral Hepatitis Coinfection

Post Date: 
2016-05-18
Gupta, A. Best Practices in Antiretroviral Therapy: Managing Antiretroviral Therapy in HIV-Infected Patients with Viral Hepatitis Coinfection. Gupta A. Best Practices in Antiretroviral Therapy: Managing Antiretroviral Therapy in HIV-Infected Patients with Viral Hepatitis Coinfection. Contemporary...

Double Trouble: Managing and Preventing TB and HIV

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2016-04-20
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Gupta, A. Double Trouble: Managing and Preventing TB and HIV. DY Patil University. Pune, India.

High TB Risk in HIV-Positive Patients on Second line Antiretrovirals in Pune, India

Post Date: 
2016-02-24
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Mave V , Kadam D, Salvi S, Basavaraj A, Joshi S, Chandanwale A, Gupte N, Bollinger RC, Gupta A. High TB Risk in HIV-Positive Patients on Second line Antiretrovirals in Pune, India. Conference on Retroviruses and Opportunistic Infections 2016. Boston, MA. 2016.

Incidence and Risk Factors for TB among HIV+ Children in India

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2015-12-05
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Kinikar AA , DeLuca A, Gupte N, Kadam DB, Khadse S, Chandanwale A, Gupta A, Bollinger R. Incidence and Risk Factors for TB among HIV+ Children in India. The 46th Union World Conference on Lung Health. Cape Town, South Africa.

Charting a Course in Interdisciplinary Research by Building Bridges with a Clinical Trial of Mother-infant HIV Transmission

Post Date: 
2015-06-12
Bollinger, R. Charting a Course in Interdisciplinary Research by Building Bridges with a Clinical Trial of Mother-infant HIV Transmission. Johns Hopkins Center for AIDS Research. Baltimore, MD.

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