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Acquired Immunodeficiency Syndrome(AIDS) and Tuberculosis(Tb) Co-infection Treatment Strategies Study of China.

This study is currently recruiting participants.
Verified August 2008 by Shanghai Public Health Clinical Center
Sponsor:
Information provided by:
Shanghai Public Health Clinical Center
ClinicalTrials.gov Identifier:
NCT01344148
First received: September 14, 2010
Last updated: April 27, 2011
Last verified: August 2008
History of Changes
  Purpose

To determine the best time to begin anti-HIV(Acquired Immunodeficiency Syndrome) treatment in individuals who co-infected with HIV and tuberculosis (Tb). This prospective, randomized study is being conducted on HIV/Tb co-infected patients in China to evaluate and compare the efficacy of antiretroviral therapy after 2 weeks TB treatment versus deferred ART initiated 8 weeks after initiation of TB treatment.


Condition Intervention
AIDS
 Drug: INH RIF Rifb PZA EMB AZT 3TC D4T EFV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AIDS and Tuberculosis Co-infection Treatment Strategies Study of China.[ Eleven Fifth Key Research Grant From the Ministry of Science and Technology, the People's Republic of China]

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shanghai Public Health Clinical Center:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    In China TB is the main co-infected disease of AIDS patients. This study will give the evidence for make the HIV and TB Co-infected Patients therapy tactics of China. At first, the study will prove what is the best time for begin HAART after anti-TB therapy 2 weeks or 8 weeks. And anti-TB and HAART program will also be confirmed in this study. Overall this research will measure the HIV and TB co-infected patients clinical treatment safety and tolerability of China.


Secondary Outcome Measures:
  • Patients long-term survival. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    The two groups will be follow up for more than five years and the long-term survival will be value.


Estimated Enrollment: 400
Study Start Date: February 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anti- TB therapy HAART Drug: INH RIF Rifb PZA EMB AZT 3TC D4T EFV
The first cohort study is the patients begin HAART after anti-TB therapy 2 weeks,and the second cohort is after 8 weeks begin HAART. Anti-TB therapy program is 2HREZ-4HRifb. And the first line of HAART plan is AZT+3TC+EFV and the second line plan is D4T+3TC+EFV.If begin with HAART and the RIF will change to Rifb.

Detailed Description:

Anti-Tb Therapy: 2HREZ-4HRifb(H:Isoniazid，R:Rifampicin，E:Ethambutol，Z：pyrazinamide，Rifb:Rifabutin) HAART: The first line was Zidovudine(AZT)+Lamivudine(3TC)+Efavirenz(EFV) and the second line is Stavudine(D4T)+3TC+EFV Study group one: after anti-TB therapy 2 weeks begin with High Active Antiretroviral Therapy(HAART); study group two: after anti-TB therapy 8 weeks begin with HAART. If begin with HAART and the H change with Rifb.

  Eligibility

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

Inclusion Criteria:

  • Clinical diagnosis of AIDS co-infected with TB CD4 T cell count lower than 350/ul Must be able to swallow tablets and finish the follow-up Sign the information consent form Chinese

Exclusion Criteria:

  • Can not tolerance the therapy estimated by the doctor.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344148

Contacts
Contact: Lu Hongzhou, MD. PhD +86 021 57248758 luhongzhou@fudan.edu.cn
Contact: Zhang Yunzhi, MD +86 021 57248763 zhangyunzhi3@163.com

Locations
China, Shanghai
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China, 201508
Contact: Lu Hongzhou, MD, PhD     +86 021 57248758     Luhongzhou@fudan.edu.cn    
Contact: Zhang Yunzhi, MD     +86 021 57248758     Zhangyunzhi3@163.com    
Sponsors and Collaborators
Shanghai Public Health Clinical Center
Investigators
Study Chair: Lu Hongzhou, MD. PhD Shanghai Public Health Clinical Center Affliated to Fudan University China
  More Information

No publications provided

Responsible Party: Lu Hongzhou, Shanghai Public Health Clinical Center Affiliated Fudan University
ClinicalTrials.gov Identifier: NCT01344148     History of Changes
Other Study ID Numbers: 2008ZX10001-008
Study First Received: September 14, 2010
Last Updated: April 27, 2011
Health Authority: China: Ethics Committee
China: Ministry of Health

Keywords provided by Shanghai Public Health Clinical Center:
Anti- TB
HAART
choice of the right moment

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Tuberculosis
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
 Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immune System Diseases
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on March 03, 2013