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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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]

Conditions
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AIDS

Intervention / Treatment
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* Drug: INH RIF Rifb PZA EMB AZT 3TC D4T EFV


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti- TB therapy HAART<br> | Drug: INH RIF Rifb PZA EMB AZT 3TC D4T EFV<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti- TB, HAART, choice of the right moment