Clinical

A5288- Management Using the Latest Technologies in Resource-Limited Settings to Optimize Combination Therapy After Viral Failure (MULTI-OCTAVE)

PRINCIPAL INVESTIGATORS

Dr.N.Kumarasamy

COLLABORATORS

ACTG Network

FUNDING

The National Institute of Allergy and Infectious Diseases (NIAID)

KEY OBJECTIVE

To use novel agents and contemporary management tools, including standard genotyping to select an appropriate third-line regimen, interventions to improve adherence and plasma viral load (VL) monitoring, in order to achieve a ≥ 65% rate of virologic control at 48 weeks of follow-up.

DURATIONS

May 2015 -ongoing

PUBLICATIONS

Nil

A5300/I2003-Study of MDR TB Cases and their Household Contacts: Operational Feasibility to inform PHOENIx Trial Design

PRINCIPAL INVESTIGATORS

Dr.N.Kumarasamy

COLLABORATORS

ACTG Network

FUNDING

The National Institute of Allergy and Infectious Diseases (NIAID)

KEY OBJECTIVE

To describe the feasibility of identifying, recruiting, and characterizing adult MDR TB index cases and their adult and child household contacts.
To describe the prevalence of LTBI, TB disease, and HIV infection among adult and child household contacts

DURATIONS

Feb 2016 -ongoing

PUBLICATIONS

Nil

START-INSIGHT PROTOCOL-Strategic Timing ofAntiretroviral Treatment

PRINCIPAL INVESTIGATORS

Dr.N.Kumarasamy

COLLABORATORS

National Centre in HIV Epidemiology and Clinical Research (NCHECR), University of New South Wales -- Sydney, Australia

FUNDING

Division of AIDS, The National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH)

KEY OBJECTIVE

To determine whether Early ART is superior to deferred ART in delaying the occurrence of a composite outcome consisting of AIDS, Non-AIDS, or death from any cause.

DURATIONS

May 2012 - Ongoing

PUBLICATIONS

Natural History of HIV disease in Southern India

PRINCIPAL INVESTIGATORS

Dr.N.Kumarasamy

COLLABORATORS

FUNDING

Fogarty-Brown Univ/amFar/NIH

KEY OBJECTIVE

To study the Natural history of HIV infection in the Southern regions of India

DURATIONS

1996 - Ongoing

PUBLICATIONS

TAHOD -The Treat Asia HIV Observational Database

PRINCIPAL INVESTIGATORS

Dr.N.Kumarasamy

COLLABORATORS

Treat Asia

FUNDING

Treat Asia/amFar/IeDEA/NIH

KEY OBJECTIVE

The primary objectives of the TREAT Asia HIV Observational Database are to:

  • Develop capacity in HIV clinical data collection in countries of the Asia-Pacific region.
  • Assist in evaluation of new HIV treatments for the Asia-Pacific region.
  • Monitor anti-retroviral and prophylactic treatment as related to
  • Demographics and markers of HIV disease stage.
  • Monitor toxicity to anti-retroviral therapy.
  • Examine HIV natural history, including relationship between access to, ,
  • Anti-retroviral therapy and disease progression.
  • Describe the types of cancers diagnosed and the risk factors for cancers in HIV infected persons in Asia.
  • Assess the risk of, and factors associated with opportunistic infections
  • (OI) and other AIDS-related illnesses (e.g., TB, Pneumocystis jiroveci pneumonia, hepatitis) and other serious non-AIDS-related medical
  • Outcomes (e.g., myocardial infarction, renal failure, diabetes).

DURATIONS

2008 - Ongoing

PUBLICATIONS

TApHOD- The Treat Asia Pediatric HIV Observational Database

PRINCIPAL INVESTIGATORS

Dr.N.Kumarasamy

COLLABORATORS

Treat Asia

FUNDING

Treat Asia/amFar/NIH

KEY OBJECTIVE

The objectives of TREAT Asia Pediatric HIV Observational database are to:

  • Examine HIV natural history, including relationship between access to anti-retroviral therapy and disease progression in pediatrics;
  • Develop capacity for systematic and standardized pediatric HIV clinical data collection in countries of the Asia-Pacific region;
  • Monitor anti-retroviral and prophylactic treatment as related to demographics and markers of HIV disease stage in pediatrics;
  • Monitor toxicity to anti-retroviral therapy in pediatrics; and
  • Assist in evaluation of new paediatric HIV treatments in the Asia-Pacific region

DURATIONS

2008 - ongoing

PUBLICATIONS

Optimizing HIV Care in Less Developed Countries

PRINCIPAL INVESTIGATORS

Dr.N.Kumarasamy

COLLABORATORS

Dr.Kenneth Freedberg,Dr.Rochelle Walensky,Dr.Kennth Mayer-Harvard University

FUNDING

CEPAC/MGH/NIH

KEY OBJECTIVE

  • To develop the Global AIDS Policy Model, a comprehensive state-transition model of the natural history and treatment of HIV disease in less developed countries.
  • To analyze data on HIV natural history, treatment efficacy, medical and non-medical costs, and quality of life in each of 3 countries: Côte d’Ivoire, India, and South Africa.
  • To utilize the model with country-specific data to determine the clinical impact, cost, and cost-effectiveness of different strategies for antiretroviral therapy, opportunistic infection prophylaxis, and tuberculosis preventive therapy, and to disseminate these analyses to help inform and develop country-specific guidelines for HIV care.

DURATIONS

1996-Ongoing

PUBLICATIONS

Continued Access to Darunavir/Ritonavir (DRV/RTV) in HIV-1 Infected Children and Adolescents aged 3 Years and above (TMC114-TiDP29-C232),

PRINCIPAL INVESTIGATORS

Dr.N.Kumarasamy

COLLABORATORS

FUNDING

Janssen Research and Development

KEY OBJECTIVE

This is a continued access trial for pediatric subjects who have completed treatment with DRV in TMC114-212, TMC114-228 and TMC114-230

DURATIONS

2010-ongoing

PUBLICATIONS

HIV and Ocular manifestations

PRINCIPAL INVESTIGATORS

Dr.N.Kumarasamy, Dr.J.Biswas

COLLABORATORS

Sankara Nethrlaya

FUNDING

Sankara Nethrlaya

KEY OBJECTIVE

To study the various ocular manifestations during HIV infection.

DURATIONS

1999-ongoing

PUBLICATIONS

HIV and Oral manifestations

PRINCIPAL INVESTIGATORS

Dr.N.Kumarasamy, Dr.Ranganathan Collaborators:Ragas Dental College,Chennai Dental Research Foundation

COLLABORATORS

Ragas/Chennai Dental Research Foundation

FUNDING

Ragas/Chennai Dental Research Foundation

KEY OBJECTIVE

To study the various oral manifestations during HIV infection

DURATIONS

1999-ongoing

PUBLICATIONS

GIVCYT- Ganciclovir—Intravitreous Versus Systemic—Cytomegalovirus Retinitis Trial

PRINCIPAL INVESTIGATORS

Dr.Jyotirmay Biswas, Dr.John Kempen, Dr.N.Kumarasamy, Dr. Sudharsan, Dr.S.Poongulali Funding: Sanakara Nethralaya

COLLABORATORS

FUNDING

KEY OBJECTIVE

To determine whether systemic therapy or IV Gancyclovir treatment is superior vis-à-vis the outcomes of mortality and retinitis progression for treatment of CMV retinitis among patients with AIDS in locations where IV Gancyclovir is standard of care.

DURATIONS

PUBLICATIONS

Menstrual Irregularities in Indian Women with HIV: Is immunologic status a factor?

PRINCIPAL INVESTIGATORS

Dr.Poongulali Selvamuthu, Dr. Krutika Kuppali

COLLABORATORS

Emory University School of Medicine, Division of Infectious Diseases

FUNDING

National Institutes of Health (NIH)

KEY OBJECTIVE

To assess ART adherence between HIV positive married women who work outside of their primary residence and housewives using adherence measures including questionnaires and measures of immunologic and virologic response.
To analyze barriers to ART adherence in HIV positive married working women and housewives.

DURATIONS

2012- ongoing

PUBLICATIONS

GS-US-320-0110- A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B

PRINCIPAL INVESTIGATORS

Dr.Amrose Pradeep

COLLABORATORS

Gilead Sciences

FUNDING

Gilead Sciences

KEY OBJECTIVE

To compare the efficacy of Tenofovir Alafenamide (TAF) 25 mg QD versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B at week 48 in treatment naive and treatment experienced subjects. The primary efficacy parameter is the proportion of subjects with plasma HBV DNA levels below 29IU/ml
To compare the safety and tolerability of Tenofovir Alafenamide (TAF) 25 mg QD versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B at week 48 in treatment naive and treatment experienced subjects.

DURATIONS

2014-ongoing

PUBLICATIONS