NCT00698334

Brief Summary

Tuberculosis (TB) is the most common opportunistic infection among HIV infected persons living in developing countries. Directly observed treatment, short-course (DOTS) is the internationally recommended strategy for the treatment of TB. However, the efficacy of DOTS for the treatment of HIV-associated TB is not well studied. This study aims to compare the efficacy of thrice weekly DOTS in HIV-infected versus HIV-negative patients with TB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at below P25 for phase_3 hiv-infections

Timeline
Completed

Started Apr 2006

Typical duration for phase_3 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

April 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 17, 2008

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

November 8, 2011

Status Verified

November 1, 2011

Enrollment Period

4.4 years

First QC Date

June 10, 2008

Last Update Submit

November 5, 2011

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeTuberculosis

Keywords

HIV infectionAcquired immunodeficiency syndromeTuberculosis

Outcome Measures

Primary Outcomes (1)

  • Cure rate

    6 months

Secondary Outcomes (4)

  • Treatment failure

    6 months

  • Death

    12 monts

  • Relapse

    12 months

  • Adverse drug reactions

    6 months

Study Arms (2)

HIV infected

EXPERIMENTAL

HIV infected patients with active TB

Drug: INH, Rifampicin, Ethambutol and Pyrazinamide

HIV negative

ACTIVE COMPARATOR

HIV negative patients with active TB

Drug: INH, Rifampicin, Ethambutol and Pyrazinamide

Interventions

INH, Rifampicin, Ethambutol and PyrazinamideDRUG

Directly Observed Treatment Short-course; Thrice weekly (INH 600 mg, Rifampicin 450 mg \[600 mg if more than 59 kg\], Ethambutol 1200 mg, Pyrazinamide 1500 mg)

Also known as: Category I DOTS
HIV infected

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients of either gender between 18-65 years of age
  • All HIV positive and HIV negative patients suffering from confirmed tuberculosis (Cat I) will be included in the study
  • Able to give written informed consent

You may not qualify if:

  • Patients already started on ATT for more than two weeks except when sputum smear positive with on going ATT
  • Pregnancy
  • Patients with SGOT/SGPT levels more than three times the upper limit of normal on three occasions, five times on one occasion.
  • Serious form of pulmonary and extrapulmonary tuberculosis
  • Concomitant diabetes mellitus
  • Epilepsy
  • Alcoholics
  • Terminally ill patients
  • Defaulters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medcial Sciences

New Delhi, New Delhi, 110029, India

Location

Related Publications (1)

  • Vashishtha R, Mohan K, Singh B, Devarapu SK, Sreenivas V, Ranjan S, Gupta D, Sinha S, Sharma SK. Efficacy and safety of thrice weekly DOTS in tuberculosis patients with and without HIV co-infection: an observational study. BMC Infect Dis. 2013 Oct 7;13:468. doi: 10.1186/1471-2334-13-468.

    PMID: 24099345DERIVED

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency SyndromeTuberculosis

Interventions

IsoniazidRifampinEthambutolPyrazinamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Surendra K Sharma, MD. Ph.D

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head

Study Record Dates

First Submitted

June 10, 2008

First Posted

June 17, 2008

Study Start

April 1, 2006

Primary Completion

September 1, 2010

Study Completion

April 1, 2011

Last Updated

November 8, 2011

Record last verified: 2011-11

Locations

IN(1)