NCT01014481

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

Initiation of a Once Daily Regimen of Tenofovir, Lamivudine and Efavirenz After 4 Weeks Versus 12 Weeks of Tuberculosis Treatment in HIV-1 Infected Patients (Time Study)

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Bamrasnaradura Infectious Diseases Institute · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The growing epidemic of HIV poses a serious public health threat in many countries, including Thailand. Mortality is clearly reduced in HIV and tuberculosis (TB) co-infected patients who initiate antiretroviral therapy (ART) after the treatment of TB, but the optimal timing to initiate ART is one of the major concern for patients concurrently receiving both therapies. To date, the prospective, randomized, control trial to study the optimal timing to initiate ART in the patients is still limited. In addition, the current recommendation to start ART in patients co-infected with HIV and TB is still based on expert opinions. Here, the investigators plan to investigate 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 at Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand.

Conditions

• HIV Infections
• Tuberculosis

Interventions

Type	Name	Description
DRUG	tenofovir, lamivudine, efavirenz	initiate tenofovir 300 mg/day, lamivudine 300 mg/day, efavirenz 600 mg/day between at 4 weeks and at 12 weeks after tuberculosis treatment

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-11-17
• Last updated: 2011-11-17

Locations

1 site across 1 country: Thailand