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

Not Applicable

• Conditions: AIDS
• Interventions: Drug: INH RIF Rifb PZA EMB AZT 3TC D4T EFV

• Registration Number: NCT01344148
• Lead Sponsor: Shanghai Public Health Clinical Center

Brief Summary

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

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.

Study Timeline

• Status Verified: 2008-08
• Study Start: 2009-02
• Study First Submitted: 2010-09-14
• Study First Submitted QC: 2011-04-27
• Last Update Submitted: 2011-04-27
• Study First Posted: 2011-04-28
• Last Update Posted: 2011-04-28
• Primary Completion: 2011-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti- TB therapy HAART	INH RIF Rifb PZA EMB AZT 3TC D4T EFV	-

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	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.

Secondary Outcome Measures

Name	Time	Method
Patients long-term survival.	5 years	The two groups will be follow up for more than five years and the long-term survival will be value.

Trial Locations

Locations (1)

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China