Acquired Immunodeficiency SyndromeTB-HAARTNCT01315301
Optimal Time to Initiate Antiretroviral Therapy in HIV & TB Coinfected Adults Being Treated for Tuberculosis
A study testing Comparison of different treatment strategies in people with Acquired Immunodeficiency Syndrome and Tuberculosis, run by Karolinska Institutet at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acquired Immunodeficiency Syndrome, Tuberculosis
- What is being tested?
- Comparison of different treatment strategies
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteEthiopia
- Study dates
- Aug 2008to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
Tikur Anbessa (Black Lion) Hospital
Addis Ababa, P.O.Box 9086
Wondwossen Amogne, MD, +2519114046179, wonamogne@yahoo.com
Eleni Aklillu, PhD, +47735116131, eleni.aklillu@ki.se
About this study
Official title: 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?
Read the detailed description
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.
- Conditions
- Acquired Immunodeficiency Syndrome, Tuberculosis
- Being tested
- Comparison of different treatment strategies
- Keywords
- Efavirenz, Rifampicin, HAART, Anti Tuberculosis
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of different treatment strategiesOther
Also called Treatment
600 mg efavirenz based HAART initiated one week after starting rifampicin based short course anti tuberculosis treatment.
Comparison of different treatment strategiesOther
Also called Treatment
600 mg efavirenz based HAART initiated four weeks after starting rifampicin based short course anti tuberculosis treatment
Comparison of different treatment strategiesOther
Also called Treatment
600 mg efavirenz based HAART initiated eight weeks after starting rifampicin based short course anti tuberculosis treatment.
| Study group | Role | What they receive |
|---|---|---|
| Arm-A | Active comparator | Immediate Treatment Group Receives: Other: Comparison of different treatment strategies |
| Arm-B | Active comparator | Deferred Treatment Group-1 Receives: Other: Comparison of different treatment strategies |
| Arm-C | Active comparator | Deferred Treatment Group-2 Receives: Other: Comparison of different treatment strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
all cause mortality
Measured: 24 weeks
Secondary outcomes (4)
Tuberculosis-Immune Reconstitution Inflammatory Syndrome
Measured: 24 weeks
New AIDS defining clinical events
Measured: 24 weeks
Drug Induced Liver toxicity
Measured: 24 weeks
Virologic success
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startAug 2008
- Primary completionJan 2012 (estimated)
- Study completionMar 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Addis Ababa University
- Investigators
- Eleni Aklillu, PhD, Study director, Krolinska Institutet, Stockholm, SwedenWondwossen Amogne, MD, Principal investigator, Addis Ababa University, Addis Ababa, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315301
- Sponsor's protocol ID
- SWE-2007-270
- Acronym
- TB-HAART
- Status last verified
- Mar 2011
- First submitted
- 14 Mar 2011
- Last updated
- 15 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25966339
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial to Determine the Most Appropriate Time to Start HIV Treatment in HIV & TB Coinfected Adults Being Treated for Tuberculosis.
- ClinicalTrials.gov ID
- NCT01315301
- Acronym / sponsor ID
- TB-HAART / SWE-2007-270
- Conditions
- Acquired Immunodeficiency Syndrome, Tuberculosis
- Keywords
- Efavirenz, Rifampicin, HAART, Anti Tuberculosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Addis Ababa University
- Study start
- Aug 2008
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Mar 2012 (estimated)
- First posted
- 15 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm-A | Active comparator | Other: Comparison of different treatment strategiesImmediate Treatment Group |
| Arm-B | Active comparator | Other: Comparison of different treatment strategiesDeferred Treatment Group-1 |
| Arm-C | Active comparator | Other: Comparison of different treatment strategiesDeferred Treatment Group-2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparison of different treatment strategiesAlso: Treatment600 mg efavirenz based HAART initiated one week after starting rifampicin based short course anti tuberculosis treatment. | Other | Arm-A |
| Comparison of different treatment strategiesAlso: Treatment600 mg efavirenz based HAART initiated four weeks after starting rifampicin based short course anti tuberculosis treatment | Other | Arm-B |
| Comparison of different treatment strategiesAlso: Treatment600 mg efavirenz based HAART initiated eight weeks after starting rifampicin based short course anti tuberculosis treatment. | Other | Arm-C |
Primary outcome
mortality
Time frame: 24 weeks
all cause mortality
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2011.
- Derived from this study: PubMed 25966339Amogne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleni Aklillu, PhD study director
Krolinska Institutet, Stockholm, Sweden
Wondwossen Amogne, MD principal investigator
Addis Ababa University, Addis Ababa, Ethiopia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of different treatment strategies in people with Acquired Immunodeficiency Syndrome and Tuberculosis, run by Karolinska Institutet at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wondwossen Amogne, MD (+251911406179, wonamogne@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01315301, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2011.