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Safety and Efficacy of Two Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
National AIDS Control Organisation
Indian Council of Medical Research
Information provided by:
Tuberculosis Research Centre, India

Brief Summary:

Protocol Summary

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.

  1. Tuberculosis Research Centre, Chennai
  2. Government Medical College, Vellore
  3. Government Hospital of Thoracic Medicine, Tambaram
  4. Government Rajaji Hospital, Madurai

Study Duration: 26 months including 24 months of ART.

Study Objectives:

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 2
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To compare the response to treatment between partially supervised drug administration and unsupervised drug administration. [ Time Frame: Dec 2009 ]
  2. To compare the tolerability and toxicity attributable to study drugs. [ Time Frame: Dec 2009 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age > 18 years
  2. a) Newly diagnosed sputum smear positive tuberculosis (at least 1 out of 6 sputum specimen should be positive by smear) b)Miliary tuberculosis, mediastinal/hilar lymphadenopathy, diagnosed by chest radiography or CT scan (irrespective of sputum smear status).

    c)TB lymphadenitis with histopathological/bacteriological evidence of TB d)Pleural effusion with biochemical/cytological/bacteriological evidence of TB

  3. HIV-1 positivity (on 2 different rapid tests on the same blood sample)
  4. CD4 cell counts less than 250 cells/mm3
  5. Likely to remain in the same area for at least two years after start of treatment.
  6. Willingness to stay in the hospital for 2 weeks during initiation of ART, and attend the clinic thrice weekly for the entire period of the study (up to 2 years).
  7. Willingness for home visits, and to attend for investigations, supervised treatment and follow-up as required.
  8. Within the area of intake (25 kms from any of the TRC subcentres).
  9. Willingness to use contraception during trial period.

Exclusion Criteria:

  1. Resides outside area of intake.
  2. Pregnancy and lactation.
  3. Patients with major psychiatric illnesses and severe depression
  4. Major complications of HIV disease like encephalopathy, renal (Serum creatinine level > 1.2 mgs/dl) or hepatic disease (Serum bilirubin > 2.0 times upper limit of normal, Serum transaminases > 2.5 times upper limit of normal), serum amylase > 2 times upper limit of normal with serum lipase > 1.5 times upper limit of normal.
  5. Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, cancer, moribund state
  6. Previous antituberculosis treatment for more than 1 month.
  7. Previous antiretroviral treatment for more than 1 month
  8. Patients with CD4 cell count >250 cells/mm3.
  9. HIV-2 infection alone or in combination with HIV-1.
  10. Patients currently using alcohol, IV drugs & other substance abuse.
  11. Unwilling to use contraception & avoid pregnancy.
  12. Unwilling to HIV/TB screening and participation in trial.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00332306

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Tuberculosis Research Centre
Chennai, Tamilnadu, India, 600031
Sponsors and Collaborators
Tuberculosis Research Centre, India
National AIDS Control Organisation
Indian Council of Medical Research
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Principal Investigator: Soumya Swaminathan, MD Tuberculosis Research Centre, India
Study Director: PR Narayanan, PhD Tuberculosis Research Centre, India

Additional Information:
J. M. Molina, S Perusat, F Ferchal, C Rancinan, F raffi, W Rozenbaum, D Sereni, P Morlat, G Chene and the Montana Study Group: Once-Daily Combination Therapy with Emtricitabine, Didanosine and Efavirenz in Treatment-Naïve HIV-Infected Adults: 64-week Follow-Up of the ANRS 091 Trial.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr Soumya Swaminathan, Tuberculosis Research Centre Identifier: NCT00332306    
Other Study ID Numbers: trc23
First Posted: June 1, 2006    Key Record Dates
Last Update Posted: October 8, 2009
Last Verified: January 2009
Keywords provided by Tuberculosis Research Centre, India:
Once daily antiretroviral treatment
Concomitant antituberculosis treatment
HIV Infections
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Anti-Retroviral Agents
Antitubercular Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Cytochrome P-450 CYP2C9 Inhibitors