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

Phase 4

Terminated

• Conditions: Tuberculosis; HIV Infections
• Interventions: Drug: tenofovir, lamivudine, efavirenz

• Registration Number: NCT01014481
• Lead Sponsor: Bamrasnaradura Infectious Diseases Institute

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.

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-16
• Study First Submitted QC: 2009-11-16
• Study First Posted: 2009-11-17
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-16
• Last Update Posted: 2011-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
start antiretroviral treatment	tenofovir, lamivudine, efavirenz	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

Primary Outcome Measures

Name	Time	Method
death rate	48 weeeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health; 🇹🇭 Nonthaburi, Thailand