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

April 27, 2011 updated by: Shanghai Public Health Clinical Center

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]

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201508
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients long-term survival.
Time Frame: 5 years
The two groups will be follow up for more than five years and the long-term survival will be value.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Public Health Clinical Center

Investigators

  • Study Chair: Lu Hongzhou, MD. PhD, Shanghai Public Health Clinical Center Affliated to Fudan University China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ANTICIPATED)

June 1, 2011

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

April 27, 2011

First Posted (ESTIMATE)

April 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2011

Last Update Submitted That Met QC Criteria

April 27, 2011

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008ZX10001-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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