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
  Purpose

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 Intervention Phase
HIV Infections
Tuberculosis
Drug: tenofovir, lamivudine, efavirenz
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Bamrasnaradura Infectious Diseases Institute:

Primary Outcome Measures:
  • death rate [ Time Frame: 48 weeeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 156
Study Start Date: October 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: at 4 weeks versus at 12 weeks after tuberculosis treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014481

Locations
Thailand
Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health
Nonthaburi, Thailand, 11000
Sponsors and Collaborators
Bamrasnaradura Infectious Diseases Institute
Mahidol University
Thai Red Cross AIDS Research Centre
Investigators
Principal Investigator: Weerawat Manosuthi, MD Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand
  More Information

No publications provided by Bamrasnaradura Infectious Diseases Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Weerawat Manosuthi, Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health
ClinicalTrials.gov Identifier: NCT01014481     History of Changes
Other Study ID Numbers: 0435.3/1551
Study First Received: November 16, 2009
Last Updated: November 16, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Bamrasnaradura Infectious Diseases Institute:
HIV
tuberculosis
antiretroviral treatment
timing

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lamivudine
Tenofovir
Tenofovir disoproxil
Efavirenz
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on July 24, 2014