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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Shanghai Public Health Clinical Center.
Recruitment status was  Recruiting
Information provided by:
Shanghai Public Health Clinical Center Identifier:
First received: September 14, 2010
Last updated: April 27, 2011
Last verified: August 2008
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

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:

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.

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

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
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 identifier: NCT01344148

Contact: Lu Hongzhou, MD. PhD +86 021 57248758
Contact: Zhang Yunzhi, MD +86 021 57248763

China, Shanghai
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China, 201508
Contact: Lu Hongzhou, MD, PhD    +86 021 57248758   
Contact: Zhang Yunzhi, MD    +86 021 57248758   
Sponsors and Collaborators
Shanghai Public Health Clinical Center
Study Chair: Lu Hongzhou, MD. PhD Shanghai Public Health Clinical Center Affliated to Fudan University China
  More Information

Responsible Party: Lu Hongzhou, Shanghai Public Health Clinical Center Affiliated Fudan University 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
choice of the right moment

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Actinomycetales Infections
Bacterial Infections
Gram-Positive Bacterial Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Mycobacterium Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases processed this record on May 25, 2016