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

HIV Infections Clinical Trial

— TIME  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01014481
• Other study ID #: 0435.3/1551
• Status: Terminated
• Phase: Phase 4
• First received: November 16, 2009
• Last updated: November 16, 2011
• Start date: October 2009
• Est. completion date: May 2011

Study information

• Verified date: November 2011
• Source: Bamrasnaradura Infectious Diseases Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 156
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Tuberculosis

Intervention

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

Locations

Country	Name	City	State
Thailand	Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health	Nonthaburi

Sponsors (3)

Lead Sponsor	Collaborator
Bamrasnaradura Infectious Diseases Institute	Mahidol University, Thai Red Cross AIDS Research Centre

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death rate		48 weeeks	Yes
Secondary	hospitalization		48 weeks	Yes
Secondary	adverse events		48 weeks	Yes
Secondary	composite endpoint of a. death b. hospitalization and c. adverse event		48 weeks	Yes
Secondary	TB IRIS		48 weeks	Yes
Secondary	Risk of death		48 weeks	Yes