NCT00031057

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P50-P75 for not_applicable hiv-infections

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2002

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Last Updated

February 28, 2011

Status Verified

November 1, 2004

First QC Date

February 20, 2002

Last Update Submit

February 25, 2011

Conditions

HIV Infections

Keywords

Administration, OralBloodReverse Transcriptase InhibitorsRiboflavinThiamineVitamin B ComplexLactic Acid

Interventions

Thiamine hydrochlorideDRUG
RiboflavinDRUG

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients may be eligible for this study if they:
  • Are at least 13 years old.
  • Give written informed consent. Patients less than 18 years old must have written informed consent of a parent or guardian.
  • Are HIV-infected.
  • Have been using anti-HIV therapy containing an NRTI for at least 4 weeks before study entry and have no plan to change their anti-HIV treatment during the study.
  • Fulfill at least 1 criterion listed in protocol indicating an elevated venous lactate measurement.

You may not qualify if:

  • Patients may not be eligible for this study if they:
  • Have inflammation of the pancreas 30 days before study entry.
  • Have other medical conditions that may result in elevated lactate levels.
  • Are pregnant or breast-feeding.
  • Started experiencing certain symptoms within 30 days prior to study entry that might be due to hyperlactatemia.
  • Have used metformin within 30 days prior to study entry.
  • Have used high-dose vitamin supplements containing vitamin B1 (thiamine) and/or vitamin B2 (riboflavin) within 30 days prior to study entry.
  • Have used certain dietary supplements within 30 days prior to study entry.
  • Use chemotherapy.
  • Are receiving any unknown therapies or medications.
  • Are allergic or sensitive to the study drug.
  • Had an illness within 30 days before study entry that, in the opinion of the investigator, would interfere with the study.
  • Use drugs or alcohol that, in the opinion of the investigator, would interfere with the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beth Israel Med Ctr

New York, New York, 10003, United States

Location

Univ of North Carolina

Chapel Hill, North Carolina, 275997215, United States

Location

Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

  • Wohl DA, Pilcher CD, Evans S, Revuelta M, McComsey G, Yang Y, Zackin R, Alston B, Welch S, Basar M, Kashuba A, Kondo P, Martinez A, Giardini J, Quinn J, Littles M, Wingfield H, Koletar SL; Adult AIDS Clinical Trials Group A5129 Team. Absence of sustained hyperlactatemia in HIV-infected patients with risk factors for mitochondrial toxicity. J Acquir Immune Defic Syndr. 2004 Mar 1;35(3):274-8. doi: 10.1097/00126334-200403010-00008.

    PMID: 15076242RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

thiamine hydrochlorideRiboflavin

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

FlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological Factors

Study Officials

  • Christopher Pilcher

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

February 20, 2002

First Posted

February 22, 2002

Primary Completion

March 1, 2003

Last Updated

February 28, 2011

Record last verified: 2004-11

Locations

US(3)