Safety and Efficacy of Two Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment
|ClinicalTrials.gov Identifier: NCT00332306|
Recruitment Status : Unknown
Verified January 2009 by Tuberculosis Research Centre, India.
Recruitment status was: Active, not recruiting
First Posted : June 1, 2006
Last Update Posted : October 8, 2009
Title: Evaluation of safety and efficacy of two different once daily anti-retroviral treatment regimens along with anti-tuberculosis treatment in patients with HIV-1 and tuberculosis - Randomized Controlled Clinical Trial
Phase: Phase III trial
Population: 180 HIV-1 positive patients with tuberculosis
Number of Sites: Four.
- Tuberculosis Research Centre, Chennai
- Government Medical College, Vellore
- Government Hospital of Thoracic Medicine, Tambaram
- Government Rajaji Hospital, Madurai
Study Duration: 26 months including 24 months of ART.
Primary Objective To compare the efficacy and safety of two different once-daily anti-retroviral treatment regimens (along with standard anti-tuberculosis treatment) in patients with HIV-1 and tuberculosis, by using virologic end points.
Secondary Objective To compare the efficacy of antiretroviral treatment given under partial supervision with unsupervised treatment (once a month supply).
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis Human Immunodeficiency Virus Infections||Drug: Didanosine, Lamivudine, Efavirenz Drug: Didanosine, Lamivudine, Nevirapine||Phase 3|
Description of Agent or Intervention:
The study intervention is to start patients with HIV and tuberculosis on anti-retroviral treatment along with the continuation phase of anti-tuberculosis treatment (ATT)ie after completion of first two months of treatment. The anti-TB regimen used in this trial will be 2EHRZ3/4RH3. Two different once-daily regimens are being compared for their efficacy and adverse event profile, namely ddI + 3TC + NVP versus ddI + 3TC + EFZ. The primary aim is to study the outcome of patients treated with both ART and ATT at 6 months (24 weeks of ART). A secondary objective is to compare the utility of partially supervised directly observed treatment with unsupervised administration of anti-retroviral drugs.
Patients with HIV-1 infection and active tuberculosis (pulmonary and extrapulmonary) will be started on a four-drug intermittent short-course anti-TB regimen on recruitment to the trial. They will be randomized at the end of intensive phase of ATT to receive either of the ART regimens and the outcome measured at the end of 6 months. During this phase, both ATT and ART will be given under supervision three times a week. Patients with viral load < 400 copies/ml(favourable outcome) at this time point will be randomized to receive ART either by partial observation of treatment (three times a week)or monthly supply (unsupervised administration) and final outcome will be measured at the end of 24 months of ART. The study will provide information on the comparative efficacy of the two regimens when given with anti-TB treatment as well as any added advantage that direct observation of treatment may provide.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Safety and Efficacy of Two Different Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment in Patients With HIV-1 and Tuberculosis|
|Study Start Date :||June 2006|
|Estimated Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||December 2011|
Didanosine + Lamivudine + Nevirapine
Drug: Didanosine, Lamivudine, Nevirapine
Didanosine 250 mg once daily for patients < 60kg, 400 mg OD patients > 60kg Lamivudine 300 mg once daily Nevirapine 400 mg once daily All drugs will be given for 24 months
Active Comparator: 1
Didanosine + Lamivudine + Efavirenz
Drug: Didanosine, Lamivudine, Efavirenz
Didanosine 250mg patients <60kg, 400mg patients > 60kg once daily Lamivudine 300 mg once daily Efavirenz 600 mg once daily All drugs will be given for 24 months
- Suppression of Viral load to < 400 copies/ml or a two log reduction in viral load from the baseline value at the end of 6 months and a viral load <400 copies/ml at 24 months of antiretroviral therapy [ Time Frame: Dec 2008 ]
- To compare the response to treatment between partially supervised drug administration and unsupervised drug administration. [ Time Frame: Dec 2009 ]
- To compare the tolerability and toxicity attributable to study drugs. [ Time Frame: Dec 2009 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332306
|Tuberculosis Research Centre|
|Chennai, Tamilnadu, India, 600031|
|Principal Investigator:||Soumya Swaminathan, MD||Tuberculosis Research Centre, India|
|Study Director:||PR Narayanan, PhD||Tuberculosis Research Centre, India|