Please select the eligibility criteria that correspond to the clinical trial below.
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
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).


Options:
A: Inclusion Criteria:

* Age 18-60 years
* Positive Serology for HIV-1
* Naïve to antiretroviral therapy
* Baseline CD4 cell counts \<250 cells/mm3
* Diagnosed active tuberculosis by clinical features and/or positive acid fast stain and/or positive culture
* Received rifampicin at least 4 weeks but not exceed 16 weeks prior to enrollment
* Willing to participate and sign inform consent

Exclusion Criteria:

* Aspartate transferase enzymes (AST) or alanine transminase enzyme (ALT) \>5 times of upper limit
* total bilirubin \>3 times of upper limit
* serum creatinine) \>2 times of upper limit
* pregnancy or lactation
* receiving immunosuppressive drugs
* receiving any drugs that may have drug-drug interaction with nevirapine and rifampicin
* chronic alcoholic drunken and intravenous drug users
* Previously received single dose of nevirapine to prevent mother to child transmission
* positive for serum cryptococcal antigen
B: 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.
C: Inclusion Criteria:

* Person HIV infected
* Aged of 18 years or more
* Signed informed consent
* New case of tuberculosis: patient who never received TB treatment or for less than 1 month
* Patients receiving rifampicin based TB regimen since 4 to 6 weeks
* CD4 cell count \< 250 cell/mm3 in the 4 weeks following the TB diagnosis
* Naïve of HAART
* For women of childbearing age, to have a negative plasmatic test for pregnancy and to accept to take a contraception or declare no wish of pregnancy in the coming year.

Exclusion Criteria:

* To have a positive plasmatic test for pregnancy
* Karnofsky score \<60%
* ALAT \> 4N (Hepatitis grade 3 or 4)
* Ongoing psychiatric pathology
* Refuse to participate in the study

Amendment :

* bilirubin \> grade 3
* any grade 4 clinical sign or biological result at time of inclusion
D: Inclusion Criteria:

1. HIV infection, documented by ELISA test
2. Adult patients
3. Patients co-infected with HIV and Tuberculosis
4. Concomitant use of Nevirapine and Rifampicin in patients co-infected with HIV and Tuberculosis
5. ART Naïve patients

Exclusion Criteria:

1. Allergy/hypersensitivity to any study drug(s).
2. Prior history of documented drug-resistant TB.
3. Pregnancy
4. Patients with alanine aminotransferase or aspartate aminotransferase levels more than five times the upper limit of normal.
5. Chronic liver disease due to cirrhosis of liver, hepatitis B \& C virus infection.
6. Chronic alcoholic.
7. Non-complaint patients.
8. Migrant patients.
9. Serious form of pulmonary or extrapulmonary tuberculosis e.g. severe haemoptysis and unconscious patients
10. Concomitant diabetes mellitus.
11. Epilepsy
12. Patients on other immunosuppressive therapy.
13. Malignancy other than Kaposi's Sarcoma requiring therapy.

Answer: B