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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
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

September 14, 2010
April 27, 2011
February 2009
June 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01344148 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Acquired Immunodeficiency Syndrome(AIDS) and Tuberculosis(Tb) Co-infection Treatment Strategies Study of China.
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]

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
AIDS
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.
Experimental: Anti- TB therapy HAART
Intervention: Drug: INH RIF Rifb PZA EMB AZT 3TC D4T EFV
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
June 2013
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Lu Hongzhou, MD. PhD +86 021 57248758 luhongzhou@fudan.edu.cn
Contact: Zhang Yunzhi, MD +86 021 57248763 zhangyunzhi3@163.com
China
 
NCT01344148
2008ZX10001-008
Yes
Lu Hongzhou, Shanghai Public Health Clinical Center Affiliated Fudan University
Shanghai Public Health Clinical Center
Not Provided
Study Chair: Lu Hongzhou, MD. PhD Shanghai Public Health Clinical Center Affliated to Fudan University China
Shanghai Public Health Clinical Center
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP