NCT01315301

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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?

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

Interventions

Type	Name	Description
OTHER	Comparison of different treatment strategies	600 mg efavirenz based HAART initiated one week after starting rifampicin based short course anti tuberculosis 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	Comparison of different treatment strategies	600 mg efavirenz based HAART initiated eight weeks after starting rifampicin based short course anti tuberculosis treatment.

Timeline

• Start date: 2008-08-01
• Primary completion: 2012-01-01
• Completion: 2012-03-01
• First posted: 2011-03-15
• Last updated: 2011-03-15

Locations

1 site across 1 country: Ethiopia