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