Protocol > Research Study
Himanshu M, Singh KR, Shougrakpam J
2018 July 1
4. OBJECTIVES
Primary objective
The primary objective of this study is to assess the effectiveness of HCV curative treatments in
patients with chronic hepatitis C (CHC), co-infected with HIV in Manipur, India.
Secondary objectives
a. To describe the demographic, clinical and biological characteristics of patients with chronic
hepatitis C and HIV co-infection
b. To assess the effectiveness of HCV curative strategies in patients with chronic HCV, co-infected
with HIV stratified by regimen and by site
c. To identify risk factors associated with differing virological responses
d. To assess the safety of HCV treatment
e. To monitor the safety of HCV treatment in HIV co-infected patients
f. To document the clinical and biological tolerance of the HCV treatment
g. To assess the feasibility of HCV treatment
h. To assess comparative performance of elastography (Fibroscan®) and APRI (AST to Platelet
Ration Index), to evaluate liver fibrosis among HIV/HCV co-infected individuals
i. To describe causes of non-eligibility for treatment
j. To describe the clinical and biological evolution of co-infected patients, not eligible for HCV
treatment
k. To assess treatment adherence
Primary objective
The primary objective of this study is to assess the effectiveness of HCV curative treatments in
patients with chronic hepatitis C (CHC), co-infected with HIV in Manipur, India.
Secondary objectives
a. To describe the demographic, clinical and biological characteristics of patients with chronic
hepatitis C and HIV co-infection
b. To assess the effectiveness of HCV curative strategies in patients with chronic HCV, co-infected
with HIV stratified by regimen and by site
c. To identify risk factors associated with differing virological responses
d. To assess the safety of HCV treatment
e. To monitor the safety of HCV treatment in HIV co-infected patients
f. To document the clinical and biological tolerance of the HCV treatment
g. To assess the feasibility of HCV treatment
h. To assess comparative performance of elastography (Fibroscan®) and APRI (AST to Platelet
Ration Index), to evaluate liver fibrosis among HIV/HCV co-infected individuals
i. To describe causes of non-eligibility for treatment
j. To describe the clinical and biological evolution of co-infected patients, not eligible for HCV
treatment
k. To assess treatment adherence
Journal Article > ReviewAbstract
Expert Rev Anti Infect Ther. 2014 January 1; Volume 12 (Issue 1); DOI:10.1586/14787210.2014.866516
Klarkowiski D, O'Brien DP, Shanks L, Singh KR
Expert Rev Anti Infect Ther. 2014 January 1; Volume 12 (Issue 1); DOI:10.1586/14787210.2014.866516
HIV rapid diagnostic tests have enabled widespread implementation of HIV programs in resource-limited settings. If the tests used in the diagnostic algorithm are susceptible to the same cause for false positivity, a false-positive diagnosis may result in devastating consequences. In resource-limited settings, the lack of routine confirmatory testing, compounded by incorrect interpretation of weak positive test lines and use of tie-breaker algorithms, can leave a false-positive diagnosis undetected. We propose that heightened CD5+ and early B-lymphocyte response polyclonal cross-reactivity are a major cause of HIV false positivity in certain settings; thus, test performance may vary significantly in different geographical areas and populations. There is an urgent need for policy makers to recognize that HIV rapid diagnostic tests are screening tests and mandate confirmatory testing before reporting an HIV-positive result. In addition, weak positive results should not be recognized as valid except in the screening of blood donors.
Journal Article > ResearchFull Text
Int J Tuberc Lung Dis. 2023 December 1; Volume 27 (Issue 12); 885-898.; DOI:10.5588/ijtld.23.0341
du Cros PAK, Greig J, Cross GB, Cousins C, Berry C, et al.
Int J Tuberc Lung Dis. 2023 December 1; Volume 27 (Issue 12); 885-898.; DOI:10.5588/ijtld.23.0341
English
Français
BACKGROUND
The value, speed of completion and robustness of the evidence generated by TB treatment trials could be improved by implementing standards for best practice.
METHODS
A global panel of experts participated in a Delphi process, using a 7-point Likert scale to score and revise draft standards until consensus was reached.
RESULTS
Eleven standards were defined: Standard 1, high quality data on TB regimens are essential to inform clinical and programmatic management; Standard 2, the research questions addressed by TB trials should be relevant to affected communities, who should be included in all trial stages; Standard 3, trials should make every effort to be as inclusive as possible; Standard 4, the most efficient trial designs should be considered to improve the evidence base as quickly and cost effectively as possible, without compromising quality; Standard 5, trial governance should be in line with accepted good clinical practice; Standard 6, trials should investigate and report strategies that promote optimal engagement in care; Standard 7, where possible, TB trials should include pharmacokinetic and pharmacodynamic components; Standard 8, outcomes should include frequency of disease recurrence and post-treatment sequelae; Standard 9, TB trials should aim to harmonise key outcomes and data structures across studies; Standard 10, TB trials should include biobanking; Standard 11, treatment trials should invest in capacity strengthening of local trial and TB programme staff.
CONCLUSION
These standards should improve the efficiency and effectiveness of evidence generation, as well as the translation of research into policy and practice.
The value, speed of completion and robustness of the evidence generated by TB treatment trials could be improved by implementing standards for best practice.
METHODS
A global panel of experts participated in a Delphi process, using a 7-point Likert scale to score and revise draft standards until consensus was reached.
RESULTS
Eleven standards were defined: Standard 1, high quality data on TB regimens are essential to inform clinical and programmatic management; Standard 2, the research questions addressed by TB trials should be relevant to affected communities, who should be included in all trial stages; Standard 3, trials should make every effort to be as inclusive as possible; Standard 4, the most efficient trial designs should be considered to improve the evidence base as quickly and cost effectively as possible, without compromising quality; Standard 5, trial governance should be in line with accepted good clinical practice; Standard 6, trials should investigate and report strategies that promote optimal engagement in care; Standard 7, where possible, TB trials should include pharmacokinetic and pharmacodynamic components; Standard 8, outcomes should include frequency of disease recurrence and post-treatment sequelae; Standard 9, TB trials should aim to harmonise key outcomes and data structures across studies; Standard 10, TB trials should include biobanking; Standard 11, treatment trials should invest in capacity strengthening of local trial and TB programme staff.
CONCLUSION
These standards should improve the efficiency and effectiveness of evidence generation, as well as the translation of research into policy and practice.
Conference Material > Poster
Himanshu M, Lin Oo W, Cavalheiro AP, Mesic A, Shougrakpam J, et al.
MSF Scientific Days International 2020: Research. 2020 May 20
Conference Material > Poster
Himanshu M, Lin Oo W, Cavalheiro AP, Mesic A, Shougrakpam J, et al.
MSF Scientific Days International 2020: Research. 2020 May 20
Journal Article > Meta-AnalysisFull Text
Bull World Health Organ. 2012 February 3; Volume 90 (Issue 7); 540-550.; DOI:10.2471/BLT.11.097147
Ford NP, Kirby C, Singh KR, Mills EJ, Cooke GS, et al.
Bull World Health Organ. 2012 February 3; Volume 90 (Issue 7); 540-550.; DOI:10.2471/BLT.11.097147