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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00037063 |
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.
Condition | Intervention |
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HIV Infections |
Drug: Thiamine hydrochloride Drug: Riboflavin Drug: Ascorbic acid Drug: Vitamin E |
Study Type: | Interventional |
Study Design: | Prevention, Efficacy Study |
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 |
Estimated Enrollment: | 19 |
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.
Ages Eligible for Study: | 13 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Patients may be eligible for this study if they:
Exclusion Criteria
Patients may not be eligible for this study if they:
United States, Colorado | |
Univ of Colorado Health Sciences Ctr | |
Denver, Colorado, United States, 80262 | |
United States, Ohio | |
Case Western Reserve Univ | |
Cleveland, Ohio, United States, 44106 | |
MetroHealth Med Ctr | |
Cleveland, Ohio, United States, 441091998 | |
United States, Pennsylvania | |
Univ of Pennsylvania, Philadelphia | |
Philadelphia, Pennsylvania, United States, 19104 |
Study Chair: | Grace McComsey |
Study ID Numbers: | ACTG A5145, AACTG A5145 |
Study First Received: | May 14, 2002 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00037063 |
Health Authority: | United States: Federal Government |
Pilot Projects Recurrence Antioxidants Reverse Transcriptase Inhibitors Anti-HIV Agents |
Ascorbic Acid Alpha-Tocopherol Riboflavin Thiamine Lactic Acid |
Sexually Transmitted Diseases, Viral Tocopherol acetate Acquired Immunodeficiency Syndrome Thiamine Recurrence Immunologic Deficiency Syndromes Alpha-Tocopherol Virus Diseases |
Tocopherols Vitamin E Riboflavin HIV Infections Sexually Transmitted Diseases Retroviridae Infections Ascorbic Acid |
RNA Virus Infections Vitamin B Complex Slow Virus Diseases Antioxidants Immune System Diseases Molecular Mechanisms of Pharmacological Action Growth Substances Physiological Effects of Drugs Infection |
Protective Agents Pharmacologic Actions Photosensitizing Agents Radiation-Sensitizing Agents Therapeutic Uses Vitamins Lentivirus Infections Micronutrients Dermatologic Agents |