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

Sponsor

Bamrasnaradura Infectious Diseases Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT01014481

Collaborator

Mahidol University (Other), Thai Red Cross AIDS Research Centre (Other)

156

Enrollment

Location

Arm

Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections Tuberculosis	Drug: tenofovir, lamivudine, efavirenz	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

156 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: start antiretroviral treatment 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	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 Other Names: at 4 weeks versus at 12 weeks after tuberculosis treatment

Arm

Intervention/Treatment

Experimental: start antiretroviral treatment

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

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

Other Names:

at 4 weeks versus at 12 weeks after tuberculosis treatment

Outcome Measures

Primary Outcome Measures

death rate [48 weeeks]

Secondary Outcome Measures

hospitalization [48 weeks]
adverse events [48 weeks]
composite endpoint of a. death b. hospitalization and c. adverse event [48 weeks]
TB IRIS [48 weeks]
Risk of death [48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18-65 years of age
HIV-1 infected patients
Naïve to antiretroviral treatment
Baseline CD4 cell count <350 cells/mm3 at enrolment
Diagnosed as having active tuberculosis by clinical features or positive acid fast stain or positive TB culture; and receiving rifampicin containing antituberculous regimen
Signed inform consent

Exclusion Criteria:

Serum transaminase enzymes ≥ 5 times of upper normal limit or total bilirubin ≥ 3 times of upper normal limit
Serum creatinine ≥ 2 times of upper normal limit
Lactation or pregnancy
Receiving any immunosuppressive agents