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

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuberculosis Research Centre, India
• Collaborators: Indian Council of Medical Research; National AIDS Control Organisation
• Treatments: Antitubercular Agents; Didanosine; Efavirenz; Lamivudine; Nevirapine

Criteria

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.