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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti- TB therapy HAART | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INH RIF Rifb PZA EMB AZT 3TC D4T EFV | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patients long-term survival. | The two groups will be follow up for more than five years and the long-term survival will be value. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lu Hongzhou, MD. PhD | Contact | +86 021 57248758 | luhongzhou@fudan.edu.cn | |
| Zhang Yunzhi, MD | Contact | +86 021 57248763 | zhangyunzhi3@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lu Hongzhou, MD. PhD | Shanghai Public Health Clinical Center Affliated to Fudan University China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Recruiting | Shanghai | Shanghai Municipality | 201508 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29587840 | Derived | Ji YJ, Liang PP, Shen JY, Sun JJ, Yang JY, Chen J, Qi TK, Wang ZY, Song W, Tang Y, Liu L, Zhang RF, Shen YZ, Lu HZ. Risk factors affecting the mortality of HIV-infected patients with pulmonary tuberculosis in the cART era: a retrospective cohort study in China. Infect Dis Poverty. 2018 Mar 24;7(1):25. doi: 10.1186/s40249-018-0405-8. |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |