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

Sponsor:	Bamrasnaradura Infectious Diseases Institute
Collaborators:	Mahidol University Thai Red Cross AIDS Research Centre
Information provided by:	Bamrasnaradura Infectious Diseases Institute
ClinicalTrials.gov Identifier:	NCT01014481

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 IV

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

MedlinePlus related topics: AIDS Tuberculosis

Drug Information available for: Lamivudine Tenofovir Efavirenz Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by Bamrasnaradura Infectious Diseases Institute:

Primary Outcome Measures:

the composite end point of death rate, hospitalization rate and adverse drug reactions [ Time Frame: 48 weeeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	210
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
start antiretroviral treatment: Experimental 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

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, 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.

Eligibility

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

Criteria

Inclusion Criteria:

18-65 years of age
HIV-1 infected patients
Naïve to antiretroviral treatment
Baseline CD4 cell count <350 cells/mm3 at enrolment
Diagnosed as having active tuberculosis by clinical features or positive acid fast stain or positive TB culture; and receiving rifampicin containing antituberculous regimen
Signed inform consent

Exclusion Criteria:

Serum transaminase enzymes ≥ 5 times of upper normal limit or total bilirubin ≥ 3 times of upper normal limit
Serum creatinine ≥ 2 times of upper normal limit
Lactation or pregnancy
Receiving any immunosuppressive agents

Contacts and Locations

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

Locations

Thailand
Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health	Recruiting
Nonthaburi, Thailand, 11000
Contact: Weerawat Manosuthi, MD +6625903408 ext - drweerawat@hotmail.com
Contact: Supeda Thongyen +6625903632 ext - supeda_t@yahoo.com
Principal Investigator: Weerawat Manosuthi, MD

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

Responsible Party:	Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health ( Weerawat Manosuthi )
Study ID Numbers:	0435.3/1551
Study First Received:	November 16, 2009
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT01014481 History of Changes
Health Authority:	Thailand: Ethical Committee

Keywords provided by Bamrasnaradura Infectious Diseases Institute:

HIV
tuberculosis
antiretroviral treatment
timing

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Lamivudine
Infection
Reverse Transcriptase Inhibitors
Gram-Positive Bacterial Infections
Anti-Retroviral Agents
Therapeutic Uses
Tenofovir
Tuberculosis
Retroviridae Infections
Nucleic Acid Synthesis Inhibitors

Tenofovir disoproxil
Efavirenz
RNA Virus Infections
Anti-HIV Agents
Immune System Diseases
Acquired Immunodeficiency Syndrome
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Immunologic Deficiency Syndromes
Actinomycetales Infections
Virus Diseases
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections

ClinicalTrials.gov processed this record on February 08, 2010