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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR THIAMINE HYDROCHLORIDE

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Clinical Trials for Thiamine Hydrochloride

Trial ID Title Status Sponsor Phase Summary
NCT00031057 Vitamin B Therapy for Hyperlactatemia Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A The purpose of this study is to see if vitamin B can treat mild hyperlactatemia (a higher than normal level of lactate in the blood) in patients who take nucleoside reverse transcriptase inhibitors (NRTIs). Hyperlactatemia is a potentially life-threatening condition that can be associated with NRTI therapy. A lack of vitamin B may be related to the development of hyperlactatemia. However, no studies have been done to evaluate this. This study proposes that high doses of vitamin B may bring elevated lactate levels back to normal among patients taking NRTIs.
NCT00143702 D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE) Completed CIHR Canadian HIV Trials Network Phase 2/Phase 3 The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed. Participants will be randomly assigned to one of four groups: - Group 1 participants will continue to take d4T as part of their antiretroviral (ARV) regimen, and will be given the vitamin supplements - Group 2 will continue to take d4T without vitamin supplements - Group 3 will switch from d4T to abacavir and receive the vitamins - Group 4 will switch from d4T to abacavir without vitamin supplements. The study plans to involve eighty participants from Canada and Argentina for a treatment period of 16 weeks and a follow-up visit at week 24.
NCT00143702 D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE) Completed GlaxoSmithKline Phase 2/Phase 3 The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed. Participants will be randomly assigned to one of four groups: - Group 1 participants will continue to take d4T as part of their antiretroviral (ARV) regimen, and will be given the vitamin supplements - Group 2 will continue to take d4T without vitamin supplements - Group 3 will switch from d4T to abacavir and receive the vitamins - Group 4 will switch from d4T to abacavir without vitamin supplements. The study plans to involve eighty participants from Canada and Argentina for a treatment period of 16 weeks and a follow-up visit at week 24.
NCT00143702 D4T or Abacavir Plus Vitamin Enhancement in HIV-Infected Patients (DAVE) Completed University of British Columbia Phase 2/Phase 3 The purpose of this study is to determine the best way to treat people on d4T (stavudine) with high levels of lactic acid. Switching from d4T to abacavir will be assessed. Adding riboflavin and thiamine will also be assessed. Participants will be randomly assigned to one of four groups: - Group 1 participants will continue to take d4T as part of their antiretroviral (ARV) regimen, and will be given the vitamin supplements - Group 2 will continue to take d4T without vitamin supplements - Group 3 will switch from d4T to abacavir and receive the vitamins - Group 4 will switch from d4T to abacavir without vitamin supplements. The study plans to involve eighty participants from Canada and Argentina for a treatment period of 16 weeks and a follow-up visit at week 24.
NCT00202228 Lactate Metabolism Study in HIV Infected Persons Completed Ontario HIV Treatment Network Phase 4 Lactic acidosis is a potentially life-threatening disease associated with the treatment of chronic HIV infection. Although acidosis is rare, hyperlactatemia is common and may have long term consequences yet to be recognized. Lactic acidosis is a manifestation of mitochondrial toxicity; consequences which have yet to be fully recognized and understood. In this study, we propose to look at lactate clearance and production by two methods, in four treatment groups, including HIV positive subjects on highly active antiretroviral therapy (HAART) treatment regimes and without HAART regimes, with liver steatosis and without, and compared with HIV negative controls. Supplementation with cofactors thiamine, niacin and L-carnitine, which may have a positive effect on lactate metabolism by facilitating mitochondrial function, will be studied as well.
NCT00202228 Lactate Metabolism Study in HIV Infected Persons Completed Queen's University Phase 4 Lactic acidosis is a potentially life-threatening disease associated with the treatment of chronic HIV infection. Although acidosis is rare, hyperlactatemia is common and may have long term consequences yet to be recognized. Lactic acidosis is a manifestation of mitochondrial toxicity; consequences which have yet to be fully recognized and understood. In this study, we propose to look at lactate clearance and production by two methods, in four treatment groups, including HIV positive subjects on highly active antiretroviral therapy (HAART) treatment regimes and without HAART regimes, with liver steatosis and without, and compared with HIV negative controls. Supplementation with cofactors thiamine, niacin and L-carnitine, which may have a positive effect on lactate metabolism by facilitating mitochondrial function, will be studied as well.
NCT00279266 Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy Withdrawn Loma Linda University N/A This study will examine the effect of oral thiamine (Vitamin B1) supplementation on pain in patients with diabetic peripheral neuropathy.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Thiamine Hydrochloride

Condition Name

Condition Name for Thiamine Hydrochloride
Intervention Trials
Lactic Acidosis 5
Septic Shock 5
Sepsis 5
Thiamine Deficiency 4
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Condition MeSH

Condition MeSH for Thiamine Hydrochloride
Intervention Trials
Shock, Septic 9
Acidosis, Lactic 7
Acidosis 7
Beriberi 7
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Clinical Trial Locations for Thiamine Hydrochloride

Trials by Country

Trials by Country for Thiamine Hydrochloride
Location Trials
United States 25
Canada 4
Italy 2
China 2
Australia 2
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Trials by US State

Trials by US State for Thiamine Hydrochloride
Location Trials
Massachusetts 8
Ohio 2
North Carolina 2
New York 2
Connecticut 1
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Clinical Trial Progress for Thiamine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Thiamine Hydrochloride
Clinical Trial Phase Trials
Phase 4 10
Phase 3 6
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Thiamine Hydrochloride
Clinical Trial Phase Trials
Completed 18
Recruiting 13
Not yet recruiting 7
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Clinical Trial Sponsors for Thiamine Hydrochloride

Sponsor Name

Sponsor Name for Thiamine Hydrochloride
Sponsor Trials
Beth Israel Deaconess Medical Center 7
University Medical Centre Ljubljana 2
University of Aarhus 2
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Sponsor Type

Sponsor Type for Thiamine Hydrochloride
Sponsor Trials
Other 74
NIH 5
U.S. Fed 2
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Cantor Fitzgerald
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Merck
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Johnson and Johnson
Queensland Health
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UBS

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