Appropriate Timing of HAART in Co-infected HIV/TB Patients

• Status: Terminated
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To study the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bamrasnaradura Infectious Diseases Institute
• Collaborators: Mahidol University; Thai Red Cross AIDS Research Centre
• Treatments: Efavirenz; Lamivudine; Tenofovir

Criteria

Inclusion Criteria:

1. 18-65 years of age

2. HIV-1 infected patients

3. Naïve to antiretroviral treatment

4. Baseline CD4 cell count <350 cells/mm3 at enrolment

5. Diagnosed as having active tuberculosis by clinical features or positive acid fast stain or positive TB culture; and receiving rifampicin containing antituberculous regimen

6. Signed inform consent

Exclusion Criteria:

1. Serum transaminase enzymes ≥ 5 times of upper normal limit or total bilirubin ≥ 3 times of upper normal limit

2. Serum creatinine ≥ 2 times of upper normal limit

3. Lactation or pregnancy

4. Receiving any immunosuppressive agents