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

NCT01344148 | Unknown DMC

• 1 other identifier: 2008ZX10001-008
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

AIDS

Keywords

Anti- TB; HAART; choice of the right moment

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Secondary Outcomes (1)

• Patients long-term survival.

  5 years

Study Arms (1)

Anti- TB therapy HAART

EXPERIMENTAL

Drug: INH RIF Rifb PZA EMB AZT 3TC D4T EFV

Interventions

INH RIF Rifb PZA EMB AZT 3TC D4T EFV 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.

Anti- TB therapy HAART

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Can not tolerance the therapy estimated by the doctor.

Sponsors & Collaborators

• Shanghai Public Health Clinical Center: lead

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, 201508, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 29587840 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Lu Hongzhou, MD. PhD

  Shanghai Public Health Clinical Center Affliated to Fudan University China

  STUDY CHAIR

Central Study Contacts

Lu Hongzhou, MD. PhD

CONTACT

+86 021 57248758; luhongzhou@fudan.edu.cn

Zhang Yunzhi, MD

CONTACT

+86 021 57248763; zhangyunzhi3@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: April 28, 2011
• Study Start: February 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2013
• Last Updated: April 28, 2011

Record last verified: 2008-08

Locations

CN (1)