NCT01315301

Brief Summary

Aim of the study is to determine optimal time to initiate anti-retroviral therapy in HIV/TB co-infected patients who recently started treatment for Tuberculosis by comparing immediate versus deferred initiation of HAART. The study will address the following questions;

  • Is it possible to reduce mortality rate and increase survival by early initiation of HAART during TB treatment with out compromising for adverse drug reaction, toxicity and immune reconstitution syndrome?
  • What is the risk/ benefit ratio between immediate versus deferred initiation of HAART during TB treatment with respect to safety/efficacy of TB and HIV co-treatment?
  • When is the most appropriate time to start HAART during TB treatment?

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 15, 2011

Status Verified

March 1, 2011

Enrollment Period

3.4 years

First QC Date

March 14, 2011

Last Update Submit

March 14, 2011

Conditions

Acquired Immunodeficiency SyndromeTuberculosis

Keywords

EfavirenzRifampicinHAARTAnti Tuberculosis

Outcome Measures

Primary Outcomes (1)

  • mortality

    all cause mortality

    24 weeks

Secondary Outcomes (4)

  • Tuberculosis-Immune Reconstitution Inflammatory Syndrome

    24 weeks

  • New AIDS defining clinical events

    24 weeks

  • Drug Induced Liver toxicity

    24 weeks

  • Virologic success

    24 weeks

Study Arms (3)

Arm-A

ACTIVE COMPARATOR

Immediate Treatment Group

Other: Comparison of different treatment strategies

Arm-B

ACTIVE COMPARATOR

Deferred Treatment Group-1

Other: Comparison of different treatment strategies

Arm-C

ACTIVE COMPARATOR

Deferred Treatment Group-2

Other: Comparison of different treatment strategies

Interventions

Comparison of different treatment strategiesOTHER

600 mg efavirenz based HAART initiated one week after starting rifampicin based short course anti tuberculosis treatment.

Also known as: Treatment
Arm-A

Eligibility Criteria

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

You may qualify if:

  • Newly diagnosed ART naive HIV infected patients and age \> 18 years old
  • Newly diagnosed smear +ve PTB cases (abnormal CXR and at least one sputum sample +ve for AFB)
  • Newly diagnosed smear -ve PTB cases (CXR consistent with active TB plus at least two sputum specimens negative for AFB and decision by the physician to treat for TB or smear negative for AFB but culture positive cases)
  • Tissue biopsy or FNAC results consistent with the diagnosis of tuberculosis
  • CD4 cell count \< 200/mm3 at the time of TB diagnosis
  • Residence in Addis Ababa, Ethiopia
  • Ability to give signed written/thumb sign informed consent

You may not qualify if:

  • Pregnancy and breast-feeding women
  • Patients who received anti TB therapy with in the past two years
  • Patients who have previous treatment experience with antiretroviral therapy
  • Severely ill patients Karnofsky performance status score \< 40
  • Baseline Hgb \< 8 gms/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tikur Anbessa (Black Lion) Hospital

Addis Ababa, P.O.Box 9086, Ethiopia

RECRUITING

Related Publications (1)

  • Amogne W, Aderaye G, Habtewold A, Yimer G, Makonnen E, Worku A, Sonnerborg A, Aklillu E, Lindquist L. Efficacy and Safety of Antiretroviral Therapy Initiated One Week after Tuberculosis Therapy in Patients with CD4 Counts < 200 Cells/muL: TB-HAART Study, a Randomized Clinical Trial. PLoS One. 2015 May 12;10(5):e0122587. doi: 10.1371/journal.pone.0122587. eCollection 2015.

    PMID: 25966339DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeTuberculosis

Interventions

Therapeutics

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

Study Officials

  • Eleni Aklillu, PhD

    Krolinska Institutet, Stockholm, Sweden

    STUDY DIRECTOR

  • Wondwossen Amogne, MD

    Addis Ababa University, Addis Ababa, Ethiopia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wondwossen Amogne, MD

CONTACT

+251911406179wonamogne@yahoo.com

Eleni Aklillu, PhD

CONTACT

+46735116131Eleni.aklillu@ki.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

August 1, 2008

Primary Completion

January 1, 2012

Study Completion

March 1, 2012

Last Updated

March 15, 2011

Record last verified: 2011-03

Locations

ET(1)