NCT00033176

Brief Summary

The purpose of this study is to determine the immunomodulatory and antiviral effects of the glutathione-restoring dithiol, alpha lipoic acid (ALA) in HIV-infected persons unresponsive to highly active antiretroviral treatment (HAART).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2002

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2002

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

August 18, 2006

Status Verified

July 1, 2006

First QC Date

April 8, 2002

Last Update Submit

August 17, 2006

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Keywords

complementary therapiesImmune restorationHIV infectionAIDSHAART non-responsivenessglutathione restorationlipoic aciddithiol

Interventions

Alpha Lipoic AcidDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV-positive status
  • HAART non-responsiveness as defined by 1) previous experience with at least 2 different protease inhibitors plus nucleoside analogs; 2) viral load of \>10,000 copies/cc and CD4+ cell count \>50 x 1000 cells/liter at time of enrollment

You may not qualify if:

  • Diabetic patients
  • Pregnant women
  • Asthmatic patients
  • Severely thiamine-deficient persons (e.g. alcoholics and those with polyneuritis)
  • History of supplementing on excessive amounts of N-acetylcysteine, glutathione or other antioxidant supplements, during the 2 months prior to study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Eye Clinic, Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carboxylic AcidsOrganic ChemicalsThiophenesSulfur CompoundsCoenzymesEnzymes and CoenzymesFatty AcidsLipids

Study Officials

  • Raxit J. Jariwalla, PhD

    California Institute for Medical Research

    PRINCIPAL INVESTIGATOR

  • Abha Kumar, MD

    Santa Clara Valley Medical Center

  • Jay Lalezari, MD

    Quest Clinical Research

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

April 8, 2002

First Posted

April 9, 2002

Study Start

February 1, 2002

Study Completion

August 1, 2004

Last Updated

August 18, 2006

Record last verified: 2006-07

Locations

US(2)