Acquired Immunodeficiency Syndrome(AIDS) and Tuberculosis(Tb) Co-infection Treatment Strategies Study of China.
|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
|Condition or disease||Intervention/treatment||Phase|
|AIDS||Drug: INH RIF Rifb PZA EMB AZT 3TC D4T EFV||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344148
|Contact: Lu Hongzhou, MD. PhD||+86 021 email@example.com|
|Contact: Zhang Yunzhi, MD||+86 021 firstname.lastname@example.org|
|Study Chair:||Lu Hongzhou, MD. PhD||Shanghai Public Health Clinical Center Affliated to Fudan University China|