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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01344148
Recruitment Status : Unknown
Verified August 2008 by Shanghai Public Health Clinical Center.
Recruitment status was:  Recruiting
First Posted : April 28, 2011
Last Update Posted : April 28, 2011
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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]
Study Start Date : February 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 3 years ]
    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 :
  1. Patients long-term survival. [ Time Frame: 5 years ]
    The two groups will be follow up for more than five years and the long-term survival will be value.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344148

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

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
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
ClinicalTrials.gov Identifier: NCT01344148     History of Changes
Other Study ID Numbers: 2008ZX10001-008
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: April 28, 2011
Last Verified: August 2008

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

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