Acquired Immunodeficiency Syndrome(AIDS) and Tuberculosis(Tb) Co-infection Treatment Strategies Study of China.
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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 | Intervention |
---|---|
AIDS |
Drug: INH RIF Rifb PZA EMB AZT 3TC D4T EFV |
Study Type: | Interventional |
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.
Estimated Enrollment: | 400 |
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) |
Arms | Assigned Interventions |
---|---|
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.
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
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.
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 |
Study Chair: | Lu Hongzhou, MD. PhD | Shanghai Public Health Clinical Center Affliated to Fudan University China |
No publications provided
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 |
Study First Received: | September 14, 2010 |
Last Updated: | April 27, 2011 |
Health Authority: | China: Ethics Committee China: Ministry of Health |
Keywords provided by Shanghai Public Health Clinical Center:
Anti- TB HAART choice of the right moment |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Tuberculosis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on March 03, 2013