Optimal Time to Initiate Antiretroviral Therapy in HIV & TB Coinfected Adults Being Treated for Tuberculosis (TB-HAART)
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ClinicalTrials.gov Identifier: NCT01315301 |
Recruitment Status
: Unknown
Verified March 2011 by Karolinska Institutet.
Recruitment status was: Recruiting
First Posted
: March 15, 2011
Last Update Posted
: March 15, 2011
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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?
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acquired Immunodeficiency Syndrome Tuberculosis | Other: Comparison of different treatment strategies | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 450 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Randomized Clinical Trial to Determine the Most Appropriate Time to Start HIV Treatment in HIV & TB Coinfected Adults Being Treated for Tuberculosis. |
Study Start Date : | August 2008 |
Estimated Primary Completion Date : | January 2012 |
Estimated Study Completion Date : | March 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Arm-A
Immediate Treatment Group
|
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
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Active Comparator: Arm-B
Deferred Treatment Group-1
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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
|
Active Comparator: Arm-C
Deferred Treatment Group-2
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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
|
- mortality [ Time Frame: 24 weeks ]all cause mortality
- Tuberculosis-Immune Reconstitution Inflammatory Syndrome [ Time Frame: 24 weeks ]
- New AIDS defining clinical events [ Time Frame: 24 weeks ]
- Drug Induced Liver toxicity [ Time Frame: 24 weeks ]
- Virologic success [ Time Frame: 24 weeks ]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

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315301
Contact: Wondwossen Amogne, MD | +251911406179 | wonamogne@yahoo.com | |
Contact: Eleni Aklillu, PhD | +46735116131 | Eleni.aklillu@ki.se |
Ethiopia | |
Tikur Anbessa (Black Lion) Hospital | Recruiting |
Addis Ababa, Ethiopia, P.O.Box 9086 | |
Contact: Wondwossen Amogne, MD +2519114046179 wonamogne@yahoo.com | |
Contact: Eleni Aklillu, PhD +47735116131 eleni.aklillu@ki.se |
Study Director: | Eleni Aklillu, PhD | Krolinska Institutet, Stockholm, Sweden | |
Principal Investigator: | Wondwossen Amogne, MD | Addis Ababa University, Addis Ababa, Ethiopia |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Eleni Aklillu,PhD, Associate Professor, Karolinska Institutet, Stockholm, Sweden |
ClinicalTrials.gov Identifier: | NCT01315301 History of Changes |
Other Study ID Numbers: |
SWE-2007-270 |
First Posted: | March 15, 2011 Key Record Dates |
Last Update Posted: | March 15, 2011 |
Last Verified: | March 2011 |
Keywords provided by Karolinska Institutet:
Efavirenz Rifampicin HAART Anti Tuberculosis |
Additional relevant MeSH terms:
Immunologic Deficiency Syndromes Tuberculosis Acquired Immunodeficiency Syndrome HIV Infections Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases |
Slow Virus Diseases Efavirenz Rifampin Antitubercular Agents Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 Enzyme Inhibitors Cytochrome P-450 CYP2C19 Inhibitors Cytochrome P-450 CYP2B6 Inducers |