Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Optimal Time to Initiate Antiretroviral Therapy in HIV & TB Coinfected Adults Being Treated for Tuberculosis (TB-HAART)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Karolinska Institutet.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Addis Ababa University
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01315301
First received: March 14, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted

March 14, 2011
March 14, 2011
August 2008
January 2012   (final data collection date for primary outcome measure)
mortality [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
all cause mortality
Same as current
No Changes Posted
  • Tuberculosis-Immune Reconstitution Inflammatory Syndrome [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • New AIDS defining clinical events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Drug Induced Liver toxicity [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
  • Virologic success [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Proportion of patients with Virologic success defined as achieving a viral load of < 50 HIV-1 RNA copies/mL within 6 months of starting therapy
Same as current
Not Provided
Not Provided
 
Optimal Time to Initiate Antiretroviral Therapy in HIV & TB Coinfected Adults Being Treated for Tuberculosis
Randomized Clinical Trial to Determine the Most Appropriate Time to Start HIV Treatment in HIV & TB Coinfected Adults Being Treated for Tuberculosis.

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?

The study intends to determine the optimal time to start ART by comparing three treatment strategies of ART initiation in HIV/TB co-infected patients. Four hundred fifty newly diagnosed HIV infected patients with active TB and CD4 cell count < 200 cells/mm3 will be prospectively recruited to be assigned randomly in parallel into one of the three treatment groups (n=150 in each group) and HAART will be started at different time points as described below with extensive counseling and adherence support.

  • Arm-A (Immediate Treatment Group): Receipt of antiretroviral therapy one week after starting anti-TB treatment.
  • Arm-B (Deferred Treatment Group-1): Antiretroviral therapy will be initiated at the 4th week of starting anti-TB treatment (in the middle of the intensive phase TB treatment).
  • Arm-C (Deferred Treatment Group-2): Antiretroviral therapy will be initiated at the 8th week of starting anti-TB treatment (after completion of the intensive phase of TB treatment).

Study Design: Interventional, prospective, randomized, open-label three-armed trial with no placebo, Active control, parallel assignment, safety and efficacy study.

Study population: Previously untreated HIV-infected adult patients with TB and CD4 cell counts < 200/mm3 at the time of TB diagnosis.

Expected Total Enrollment = 450

Treatment: Patients will receive first-line preferred regimen for patients with TB and HIV coinfection (rifampicin containing short course TB treatment and efavirenz-containing HAART regimen. The intensive phase of anti-TB therapy consists of 2 months treatment with Rifampicin, Isoniazid, Pyrazinamide and Ethambutol followed by the continuation phase with Isoniazid and Rifampicin daily for 4 months under Directly Observed Therapy (DOTS). After the initiation of TB treatment, patients in Arm-A, Arm-B and Arm-C will start EFV-containing HAART regimen (efavirenz + Lamivudine (3TC) + Stavudine (d4T) after one week, in the middle(at 4th week) and at the end (8th week) of the intensive phase TB treatment respectively. Primar prophylaxis with cotrimoxazole will be offered to all patients.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Acquired Immunodeficiency Syndrome
  • Tuberculosis
  • Other: Comparison of different treatment strategies
    600 mg efavirenz based HAART initiated one week after starting rifampicin based short course anti tuberculosis treatment.
    Other Name: Treatment
  • Other: Comparison of different treatment strategies
    600 mg efavirenz based HAART initiated four weeks after starting rifampicin based short course anti tuberculosis treatment
    Other Name: Treatment
  • Other: Comparison of different treatment strategies
    600 mg efavirenz based HAART initiated eight weeks after starting rifampicin based short course anti tuberculosis treatment.
    Other Name: Treatment
  • Active Comparator: Arm-A
    Immediate Treatment Group
    Intervention: Other: Comparison of different treatment strategies
  • Active Comparator: Arm-B
    Deferred Treatment Group-1
    Intervention: Other: Comparison of different treatment strategies
  • Active Comparator: Arm-C
    Deferred Treatment Group-2
    Intervention: Other: Comparison of different treatment strategies
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
450
March 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 65 Years
No
Contact: Wondwossen Amogne, MD +251911406179 wonamogne@yahoo.com
Contact: Eleni Aklillu, PhD +46735116131 Eleni.aklillu@ki.se
Ethiopia
 
NCT01315301
SWE-2007-270
Yes
Eleni Aklillu,PhD, Associate Professor, Karolinska Institutet, Stockholm, Sweden
Karolinska Institutet
Addis Ababa University
Study Director: Eleni Aklillu, PhD Krolinska Institutet, Stockholm, Sweden
Principal Investigator: Wondwossen Amogne, MD Addis Ababa University, Addis Ababa, Ethiopia
Karolinska Institutet
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP