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

Primary Purpose

AIDS

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
INH RIF Rifb PZA EMB AZT 3TC D4T EFV
Sponsored by
Shanghai Public Health Clinical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AIDS focused on measuring Anti- TB, HAART, choice of the right moment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Public Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anti- TB therapy HAART

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 14, 2010
Last Updated
April 27, 2011
Sponsor
Shanghai Public Health Clinical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01344148
Brief Title
Acquired Immunodeficiency Syndrome(AIDS) and Tuberculosis(Tb) Co-infection Treatment Strategies Study of China.
Official Title
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]
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Public Health Clinical Center

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AIDS
Keywords
Anti- TB, HAART, choice of the right moment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anti- TB therapy HAART
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
INH RIF Rifb PZA EMB AZT 3TC D4T EFV
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Patients long-term survival.
Description
The two groups will be follow up for more than five years and the long-term survival will be value.
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Hongzhou, MD. PhD
Phone
+86 021 57248758
Email
luhongzhou@fudan.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Yunzhi, MD
Phone
+86 021 57248763
Email
zhangyunzhi3@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lu Hongzhou, MD. PhD
Organizational Affiliation
Shanghai Public Health Clinical Center Affliated to Fudan University China
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Hongzhou, MD, PhD
Phone
+86 021 57248758
Email
Luhongzhou@fudan.edu.cn
First Name & Middle Initial & Last Name & Degree
Zhang Yunzhi, MD
Phone
+86 021 57248758
Email
Zhangyunzhi3@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
29587840
Citation
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.
Results Reference
derived

Learn more about this trial

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

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