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

This study has been terminated.
(this study was ended prematurely by ethical committees with a reason of the final outcome was achieved with no longer recruitment was needed.)
Sponsor:
Collaborators:
Mahidol University
Thai Red Cross AIDS Research Centre
Information provided by:
Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier:
NCT01014481
First received: November 16, 2009
Last updated: November 16, 2011
Last verified: November 2011

November 16, 2009
November 16, 2011
October 2009
May 2011   (final data collection date for primary outcome measure)
death rate [ Time Frame: 48 weeeks ] [ Designated as safety issue: Yes ]
the composite end point of death rate, hospitalization rate and adverse drug reactions [ Time Frame: 48 weeeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01014481 on ClinicalTrials.gov Archive Site
  • hospitalization [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • composite endpoint of a. death b. hospitalization and c. adverse event [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • TB IRIS [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
  • Risk of death [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Tuberculosis
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 Name: at 4 weeks versus at 12 weeks after tuberculosis 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
Intervention: Drug: tenofovir, lamivudine, efavirenz
Kiertiburanakul S, Manosuthi W, Sungkanuparph S. Optimal timing of antiretroviral therapy initiation in patients coinfected with HIV and tuberculosis. Expert Rev Clin Pharmacol. 2011 Mar;4(2):143-6. doi: 10.1586/ecp.11.2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
156
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT01014481
0435.3/1551
No
Weerawat Manosuthi, Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health
Bamrasnaradura Infectious Diseases Institute
  • Mahidol University
  • Thai Red Cross AIDS Research Centre
Principal Investigator: Weerawat Manosuthi, MD Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand
Bamrasnaradura Infectious Diseases Institute
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP