NCT00351702

Brief Summary

Title: Evaluation of efficacy of two different preventive therapy regimens for tuberculosis in HIV infected persons Phase: Phase III trial Population: 650 HIV positive patients without tuberculosis Number of sites: Three

  1. 1.Tuberculosis Research centre, Chennai
  2. 2.Government General Hospital, Chennai
  3. 3.Government Rajaji Hospital, Madurai

Trial Health

87
On Track

Trial Health Score

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

Enrollment
683

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_3

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

February 1, 2001

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

7.6 years

First QC Date

July 12, 2006

Last Update Submit

May 20, 2024

Conditions

Human Immunodeficiency VirusTuberculosis

Keywords

Preventive therapy

Outcome Measures

Primary Outcomes (1)

  • Primary outcome measure is the development of tuberculosis.

    September 2008

Secondary Outcomes (1)

  • Secondary outcome measures include adverse drug reactions and mortality rate.

    September 2008

Study Arms (2)

Isoniazid

ACTIVE COMPARATOR

Isoniazid (300mg) daily for 36 months

Drug: Isoniazid with Ethambutol

Isoniazid + Ethambutol

EXPERIMENTAL

Isoniazid (300 mg) + Ethambutol (800 mg) daily for 6 months

Drug: Isoniazid with Ethambutol

Interventions

Isoniazid with EthambutolDRUG

Isoniazid (300mg) with Ethambutol (800mg) daily for 6 months

IsoniazidIsoniazid + Ethambutol

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age \> 15 years
  • HIV positivity (on 2 different ELISA tests on the same blood sample)
  • Living in Chennai or Madurai within a defined area of intake - 25 km radius.
  • Likely to remain in the same area for at least three years after start of treatment
  • The patient is judged to be cooperative and willing for fortnightly attendance for the next 3 years
  • Is agreeable for home visits
  • No major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease.
  • No other medical condition that might interfere with management like diabetes, convulsions, serious cardiac disease.
  • Patients who fulfill laboratory criteria (hemoglobin \> 7.0g/l,granulocyte count\>11,000/l, platelet count \> 1 lakh/l. serum alanine amino transferase concentration \< 2.5 times the upper limit of normal and serum creatinine concentration \< 1.1 mgs%, random blood sugar \< 140 mgs%) will be enrolled into the study.

You may not qualify if:

  • Resides outside area of intake.
  • Pregnancy and lactation.
  • Patients with major psychiatric illnesses and severe depression
  • Major complications of HIV disease like encephalopathy, renal or hepatic disease or end stage disease
  • Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, convulsions, cancer, moribund state
  • Previous antituberculosis treatment for more than 1 month
  • Patients on ART -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tuberculosis Research Centre

Chennai, Tamil Nadu, 600 031, India

Location

Related Publications (6)

  • Bucher HC, Griffith LE, Guyatt GH, Sudre P, Naef M, Sendi P, Battegay M. Isoniazid prophylaxis for tuberculosis in HIV infection: a meta-analysis of randomized controlled trials. AIDS. 1999 Mar 11;13(4):501-7. doi: 10.1097/00002030-199903110-00009.

    PMID: 10197379BACKGROUND

  • Wilkinson D, Squire SB, Garner P. Effect of preventive treatment for tuberculosis in adults infected with HIV: systematic review of randomised placebo controlled trials. BMJ. 1998 Sep 5;317(7159):625-9. doi: 10.1136/bmj.317.7159.625.

    PMID: 9727988BACKGROUND

  • Hawken MP, Meme HK, Elliott LC, Chakaya JM, Morris JS, Githui WA, Juma ES, Odhiambo JA, Thiong'o LN, Kimari JN, Ngugi EN, Bwayo JJ, Gilks CF, Plummer FA, Porter JD, Nunn PP, McAdam KP. Isoniazid preventive therapy for tuberculosis in HIV-1-infected adults: results of a randomized controlled trial. AIDS. 1997 Jun;11(7):875-82. doi: 10.1097/00002030-199707000-00006.

    PMID: 9189212BACKGROUND

  • Whalen CC, Johnson JL, Okwera A, Hom DL, Huebner R, Mugyenyi P, Mugerwa RD, Ellner JJ. A trial of three regimens to prevent tuberculosis in Ugandan adults infected with the human immunodeficiency virus. Uganda-Case Western Reserve University Research Collaboration. N Engl J Med. 1997 Sep 18;337(12):801-8. doi: 10.1056/NEJM199709183371201.

    PMID: 9295239BACKGROUND

  • Gordin F, Chaisson RE, Matts JP, Miller C, de Lourdes Garcia M, Hafner R, Valdespino JL, Coberly J, Schechter M, Klukowicz AJ, Barry MA, O'Brien RJ. Rifampin and pyrazinamide vs isoniazid for prevention of tuberculosis in HIV-infected persons: an international randomized trial. Terry Beirn Community Programs for Clinical Research on AIDS, the Adult AIDS Clinical Trials Group, the Pan American Health Organization, and the Centers for Disease Control and Prevention Study Group. JAMA. 2000 Mar 15;283(11):1445-50. doi: 10.1001/jama.283.11.1445.

    PMID: 10732934BACKGROUND

  • Swaminathan S, Menon PA, Gopalan N, Perumal V, Santhanakrishnan RK, Ramachandran R, Chinnaiyan P, Iliayas S, Chandrasekaran P, Navaneethapandian PD, Elangovan T, Pho MT, Wares F, Paranji Ramaiyengar N. Efficacy of a six-month versus a 36-month regimen for prevention of tuberculosis in HIV-infected persons in India: a randomized clinical trial. PLoS One. 2012;7(12):e47400. doi: 10.1371/journal.pone.0047400. Epub 2012 Dec 14.

    PMID: 23251327RESULT

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeTuberculosis

Interventions

IsoniazidEthambutol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

HydrazinesOrganic ChemicalsIsonicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-RingEthylenediaminesDiaminesPolyaminesAmines

Study Officials

  • Soumya Swaminathan, MD MNAMS

    Tuberculosis Research Centre, India

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 12, 2006

First Posted

July 13, 2006

Study Start

February 1, 2001

Primary Completion

September 1, 2008

Study Completion

June 1, 2011

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations

IN(1)