NCT00402454

Brief Summary

To evaluate adherence and safety of three regimens of chemoprophylaxis for tuberculosis (TB) in HIV-infected patients with positive tuberculin skin test.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for phase_4 hiv-infections

Timeline
Completed

Started Jan 1994

Longer than P75 for phase_4 hiv-infections

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 1994

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 1998

Completed
8 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2006

Completed
Last Updated

January 11, 2007

Status Verified

November 1, 2006

First QC Date

November 18, 2006

Last Update Submit

January 9, 2007

Conditions

HIV Infections

Keywords

HIVTuberculosisProphylaxisAIDS

Outcome Measures

Primary Outcomes (2)

  • Development of Tuberculosis

  • Suspension of chemoprophylaxis due to adverse effects

Secondary Outcomes (2)

  • Suspension of chemoprophylaxis due tovoluntary withdrawal

  • Mortality.

Interventions

isoniazid, rifampin + isoniazid or rifampin + pyrazinamideDRUG

Eligibility Criteria

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

You may qualify if:

  • HIV infection confirmed by ELISA and Western blot
  • Age between 18 and 65 years
  • Life expectancy greater than two years
  • Reactivity to PPD \> 5 mm

You may not qualify if:

  • Presence of active tuberculosis
  • Background of previous antituberculosis therapy or chemoprophylaxis
  • Presence of symptoms or signs suggesting pulmonary or extra-pulmonary tuberculosis
  • History of hypersensitivity to the drugs used in the study (isoniazid, rifampin or pyrazinamide)
  • Aspartate-aminotransferase and/or alanine-aminotransferase plasma concentrations more than or equal to four times their normal values, total bilirubin more than 2 mg/ml, and/or creatinine more than 2 mg/ml
  • Pregnancy
  • Undergoing treatment incompatible with any of the drugs used in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14002, Spain

Location

MeSH Terms

Conditions

HIV InfectionsTuberculosisAcquired Immunodeficiency Syndrome

Interventions

IsoniazidRifampinPyrazinamide

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesSlow Virus Diseases

Intervention Hierarchy (Ancestors)

HydrazinesOrganic ChemicalsIsonicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingLactams, MacrocyclicMacrocyclic CompoundsPolycyclic CompoundsPyrazines

Study Officials

  • Antonio Rivero, MD PhD

    Hospital Universitario Reina Sofía, Córdoba, Spain

    STUDY CHAIR

  • Luis Lopez-Crtés, MD, PhD

    Hospital Universitario Virgen del Rocío, Sevilla, Spain

    PRINCIPAL INVESTIGATOR

  • Rafael Castillo, MD

    3 Sección de Enfermedades Infecciosas. Hospital Clínico Universitario San Cecilio. Avda. Dr. Oloriz 16. 18012 Granada

    PRINCIPAL INVESTIGATOR

  • José Verdejo, MD

    Servicio de Enfermedades Infecciosas. Hospital Carlos III. Sinesio Delgado 10. 28029 Madrid

    PRINCIPAL INVESTIGATOR

  • Miguel Angel García, MD

    Sección de Enfermedades Infecciosas. Hospital Carlos Haya. Avda. Carlos Haya s/n. 29010 Málaga.

    PRINCIPAL INVESTIGATOR

  • Felipes Diez, MD

    Servicio de Medicina Interna. Hospital Torrecárdenas. Paraje de Torrecárdenas s/n. 04009 Almería.

    PRINCIPAL INVESTIGATOR

  • Jose Carlos Escribano, MD

    Sección de Enfermedades Infecciosas. Hospital Universitario Puerta del Mar. Avda. Ana de Viya, 21. 11009 Cádiz. Spain

    PRINCIPAL INVESTIGATOR

  • Jesús Canueto, MD

    Sección de Enfermedades Infecciosas. Hospital Punta Europa de Algeciras. Ctra de Getares s/n. 11207 Algeciras (Cádiz)., Spain

    PRINCIPAL INVESTIGATOR

  • Manuel Marquez, MD

    Unidad de Enfermedades Infecciosas. Hospital Universitario Virgen de la Victoria, Campus Universitario Teatinos s/n. 29010 Málaga.

    PRINCIPAL INVESTIGATOR

  • Juan Jose Hernandez, MD

    Unidad de Enfermedades Infecciosas. Hospital Ciudad de Jaén, Avda del Ejército Español, 10. 23007 Jaén, Spain.

    PRINCIPAL INVESTIGATOR

  • Juan Pasquau, MD

    Sección de Enfermedades Infecciosas. Hospital Universitario Virgen de las Nieves. Avda de las Fuerzas Armadas, 2. 18014 Granada, Spain.

    PRINCIPAL INVESTIGATOR

  • Fernando Lozano, MD PhD

    Sección de Enfermedades Infecciosas. Hospital Universitario Virgen de Valme. Ctra. de Cádiz s/n. 41012 Sevilla, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 18, 2006

First Posted

November 22, 2006

Study Start

January 1, 1994

Study Completion

December 1, 1998

Last Updated

January 11, 2007

Record last verified: 2006-11

Locations

ES(1)