Acquired Immunodeficiency Syndrome(AIDS) and Tuberculosis(Tb) Co-infection Treatment Strategies Study of China.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Public Health Clinical Center | Shanghai | Shanghai | China | 201508 |
Sponsors and Collaborators
- Shanghai Public Health Clinical Center
Investigators
- Study Chair: Lu Hongzhou, MD. PhD, Shanghai Public Health Clinical Center Affliated to Fudan University China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2008ZX10001-008