Optimal Time to Initiate Antiretroviral Therapy in HIV & TB Coinfected Adults Being Treated for Tuberculosis (TB-HAART)
Recruitment status was Recruiting
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Purpose
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 | Intervention |
|---|---|
|
Acquired Immunodeficiency Syndrome Tuberculosis |
Other: Comparison of different treatment strategies |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: 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. |
- mortality [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]all cause mortality
- 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
| Estimated Enrollment: | 450 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | March 2012 |
| Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
|
Active Comparator: Arm-B
Deferred Treatment Group-1
|
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
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
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 |
| Study First Received: | March 14, 2011 |
| Last Updated: | March 14, 2011 |
| Health Authority: | Ethiopia: Drug Administration and Control Authority |
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 Rifampin Efavirenz Antitubercular Agents Antibiotics, Antitubercular Anti-Bacterial Agents Anti-Infective Agents Leprostatic Agents Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Cytochrome P-450 CYP2B6 Inducers Cytochrome P-450 Enzyme Inducers Cytochrome P-450 CYP2C8 Inducers Cytochrome P-450 CYP2C19 Inducers |
ClinicalTrials.gov processed this record on September 26, 2016