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

NCT ID: NCT01344148

Last Updated: 2011-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-06-30

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.

Conditions

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AIDS

Keywords

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Anti- TB HAART choice of the right moment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anti- TB therapy HAART

Group Type EXPERIMENTAL

INH RIF Rifb PZA EMB AZT 3TC D4T EFV

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Public Health Clinical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Shanghai Public Health Clinical Center Affiliated Fudan University

Principal Investigators

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Lu Hongzhou, MD. PhD

Role: STUDY_CHAIR

Shanghai Public Health Clinical Center Affliated to Fudan University China

Locations

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Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lu Hongzhou, MD. PhD

Role: CONTACT

Phone: +86 021 57248758

Email: [email protected]

Zhang Yunzhi, MD

Role: CONTACT

Phone: +86 021 57248763

Email: [email protected]

Facility Contacts

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Lu Hongzhou, MD, PhD

Role: primary

Zhang Yunzhi, MD

Role: backup

References

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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.

Reference Type DERIVED
PMID: 29587840 (View on PubMed)

Other Identifiers

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2008ZX10001-008

Identifier Type: -

Identifier Source: org_study_id