Acquired Immunodeficiency Syndrome(AIDS) and Tuberculosis(Tb) Co-infection Treatment Strategies Study of China.
Recruitment status was Recruiting
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.
|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]|
- 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.
- 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.
|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)|
|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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344148
|Contact: Lu Hongzhou, MD. PhD||+86 021 firstname.lastname@example.org|
|Contact: Zhang Yunzhi, MD||+86 021 email@example.com|
|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|
|Study Chair:||Lu Hongzhou, MD. PhD||Shanghai Public Health Clinical Center Affliated to Fudan University China|