Status:
UNKNOWN
Safety and Efficacy of Two Once Daily Anti Retroviral Treatment Regimens Along With Anti-tuberculosis Treatment
Lead Sponsor:
Tuberculosis Research Centre, India
Collaborating Sponsors:
National AIDS Control Organisation
Indian Council of Medical Research
Conditions:
Tuberculosis
Human Immunodeficiency Virus Infections
Eligibility:
All Genders
18-61 years
Phase:
PHASE3
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...
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 treatme...
Eligibility Criteria
Inclusion
- Age \> 18 years
- 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
- HIV-1 positivity (on 2 different rapid tests on the same blood sample)
- CD4 cell counts less than 250 cells/mm3
- Likely to remain in the same area for at least two years after start of treatment.
- 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).
- Willingness for home visits, and to attend for investigations, supervised treatment and follow-up as required.
- Within the area of intake (25 kms from any of the TRC subcentres).
- Willingness to use contraception during trial period.
Exclusion
- Resides outside area of intake.
- Pregnancy and lactation.
- Patients with major psychiatric illnesses and severe depression
- 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.
- Serious cardiac disease (CCF, IHD), uncontrolled diabetes mellitus, cancer, moribund state
- Previous antituberculosis treatment for more than 1 month.
- Previous antiretroviral treatment for more than 1 month
- Patients with CD4 cell count \>250 cells/mm3.
- HIV-2 infection alone or in combination with HIV-1.
- Patients currently using alcohol, IV drugs \& other substance abuse.
- Unwilling to use contraception \& avoid pregnancy.
- Unwilling to HIV/TB screening and participation in trial.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00332306
Start Date
June 1 2006
End Date
December 1 2011
Last Update
October 8 2009
Active Locations (1)
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1
Tuberculosis Research Centre
Chennai, Tamil Nadu, India, 600031