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)”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study

Study Primary Completion Date: October 2011

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, we 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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• 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

Primary Measures

• the composite end point of death rate, hospitalization rate and adverse drug reactions
  • Time Frame: 48 weeeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bamrasnaradura Infectious Diseases Institute

Overall Clinical Trial Officials and Contacts

Weerawat Manosuthi, MD Principal Investigator Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand  

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01014481

Study ID Number: 0435.3/1551

ClinicalTrials.gov Identifier: NCT01014481

Health Authority: Thailand: Ethical Committee