Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037063
Status:
WITHDRAWN
Last Update Posted:
2015-06-04
First Post:
2002-05-14
Brief Title:
A Study to See if Certain Antioxidants and Vitamins Will Keep Lactate Levels Down in Patients Taking Anti-HIV Drugs
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Pilot Study of the Efficacy of a Combination of Antioxidants and B Vitamins in Preventing the Recurrence of Hyperlactatemia in Subjects Who Have Limited Antiretroviral Options
Status:
WITHDRAWN
Status Verified Date:
2003-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if certain vitamins C E B1 and B2 can keep lactate levels from becoming too high in patients who are taking nucleoside reverse transcriptase inhibitor NRTI anti-HIV drugs
Some patients taking anti-HIV drugs develop hyperlactatemia Hyperlactatemia is a condition in which lactate a natural substance normally present in the body levels are too high Too much lactate in the body can lead to serious health problems When patients suffer from hyperlactatemia while taking anti-HIV drugs most doctors temporarily stop the drugs Patients then restart the anti-HIV drugs when their lactate levels return to normal If patients restart the same drugs they were taking when they developed hyperlactatemia there is a risk that they may develop high lactate levels again This study wants to find out if taking antioxidants substances that reduce tissue damage due to oxygen radicals and certain B vitamins may help prevent patients from developing hyperlactatemia when they restart the same anti-HIV drugs
Some patients taking anti-HIV drugs develop hyperlactatemia Hyperlactatemia is a condition in which lactate a natural substance normally present in the body levels are too high Too much lactate in the body can lead to serious health problems When patients suffer from hyperlactatemia while taking anti-HIV drugs most doctors temporarily stop the drugs Patients then restart the anti-HIV drugs when their lactate levels return to normal If patients restart the same drugs they were taking when they developed hyperlactatemia there is a risk that they may develop high lactate levels again This study wants to find out if taking antioxidants substances that reduce tissue damage due to oxygen radicals and certain B vitamins may help prevent patients from developing hyperlactatemia when they restart the same anti-HIV drugs
Detailed Description:
Hyperlactatemia is a serious complication of NRTI treatment for HIV Most physicians temporarily discontinue antiretroviral therapy in patients with serious hyperlactatemia then restart antiretrovirals after lactate levels normalize Two options for restarting antiretrovirals are to switch to different NRTIs or switch to an NRTI-sparing regimen The latter option is probably safer but a growing number of the HIV-infected population has already been exposed to all available classes of antiretrovirals and may lack this option This study will investigate the ability of antioxidants and B vitamins to prevent the recurrence of hyperlactatemia in patients who restart the same NRTI-containing regimen
Patients have 2 clinic visits screening and pre-entry prior to entry into the study Prior to these visits patients must fast and refrain from exercise for at least 8 hours At the screening visit blood is drawn for a lactate level Women of reproductive potential have a pregnancy test At the pre-entry visit blood is drawn for a second lactate level
Within 30 days of the screening visit patients return to the clinic to enter the study Patients should not eat or drink except medications and water for at least 8 hours prior to this visit Upon study entry the following are performed a physical exam blood draw for routine lab tests HIV viral load CD4 count and repeat lactate urinalysis and a pregnancy test All patients receive the following regimen through Week 48 vitamins C E B1 and B2 One week after starting the vitamin regimen patients are restarted on the same antiretroviral regimen that they were receiving at the time of hyperlactatemia Within 30 days of study entry the patients should be on the exact same doses of antiretrovirals that they were receiving at the time of hyperlactatemia taking into account any necessary dose escalations Evaluations are performed at Weeks 2 4 6 and 8 and every 4 weeks thereafter until Week 24 After Week 24 evaluations are then performed at 8-week intervals through Week 48 Antiretrovirals are not supplied by the study
Patients have 2 clinic visits screening and pre-entry prior to entry into the study Prior to these visits patients must fast and refrain from exercise for at least 8 hours At the screening visit blood is drawn for a lactate level Women of reproductive potential have a pregnancy test At the pre-entry visit blood is drawn for a second lactate level
Within 30 days of the screening visit patients return to the clinic to enter the study Patients should not eat or drink except medications and water for at least 8 hours prior to this visit Upon study entry the following are performed a physical exam blood draw for routine lab tests HIV viral load CD4 count and repeat lactate urinalysis and a pregnancy test All patients receive the following regimen through Week 48 vitamins C E B1 and B2 One week after starting the vitamin regimen patients are restarted on the same antiretroviral regimen that they were receiving at the time of hyperlactatemia Within 30 days of study entry the patients should be on the exact same doses of antiretrovirals that they were receiving at the time of hyperlactatemia taking into account any necessary dose escalations Evaluations are performed at Weeks 2 4 6 and 8 and every 4 weeks thereafter until Week 24 After Week 24 evaluations are then performed at 8-week intervals through Week 48 Antiretrovirals are not supplied by the study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AACTG A5145 | None | None | None |