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Appropriate Timing of HAART in Co-infected HIV/TB Patients

NCT ID: NCT01014481

Last Updated: 2011-11-17

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2011-05-31

Brief Summary

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To study the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144.

Detailed Description

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The growing epidemic of HIV poses a serious public health threat in many countries, including Thailand. Mortality is clearly reduced in HIV and tuberculosis (TB) co-infected patients who initiate antiretroviral therapy (ART) after the treatment of TB, but the optimal timing to initiate ART is one of the major concern for patients concurrently receiving both therapies. To date, the prospective, randomized, control trial to study the optimal timing to initiate ART in the patients is still limited. In addition, the current recommendation to start ART in patients co-infected with HIV and TB is still based on expert opinions. Here, the investigators plan to investigate the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment by comparing the composite end point of death rate, hospitalization rate and adverse drug reactions at week 48, 96 and 144 at Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand.

Conditions

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HIV Infections Tuberculosis

Keywords

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HIV tuberculosis antiretroviral treatment timing

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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start antiretroviral treatment

the optimal timing to initiate antiretroviral therapy in HIV-infected patients who are receiving tuberculosis treatment between at 4 weeks and at 12 weeks after tuberculosis treatment

Group Type EXPERIMENTAL

tenofovir, lamivudine, efavirenz

Intervention Type DRUG

initiate tenofovir 300 mg/day, lamivudine 300 mg/day, efavirenz 600 mg/day between at 4 weeks and at 12 weeks after tuberculosis treatment

Interventions

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tenofovir, lamivudine, efavirenz

initiate tenofovir 300 mg/day, lamivudine 300 mg/day, efavirenz 600 mg/day between at 4 weeks and at 12 weeks after tuberculosis treatment

Intervention Type DRUG

Other Intervention Names

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at 4 weeks versus at 12 weeks after tuberculosis treatment

Eligibility Criteria

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Inclusion Criteria

1. 18-65 years of age
2. HIV-1 infected patients
3. Naïve to antiretroviral treatment
4. Baseline CD4 cell count \<350 cells/mm3 at enrolment
5. Diagnosed as having active tuberculosis by clinical features or positive acid fast stain or positive TB culture; and receiving rifampicin containing antituberculous regimen
6. Signed inform consent

Exclusion Criteria

1. Serum transaminase enzymes ≥ 5 times of upper normal limit or total bilirubin ≥ 3 times of upper normal limit
2. Serum creatinine ≥ 2 times of upper normal limit
3. Lactation or pregnancy
4. Receiving any immunosuppressive agents
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role collaborator

Thai Red Cross AIDS Research Centre

OTHER

Sponsor Role collaborator

Bamrasnaradura Infectious Diseases Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health

Principal Investigators

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Weerawat Manosuthi, MD

Role: PRINCIPAL_INVESTIGATOR

Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, Thailand

Locations

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Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health

Nonthaburi, Changwat Nonthaburi, Thailand

Site Status

Countries

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Thailand

References

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Kiertiburanakul S, Manosuthi W, Sungkanuparph S. Optimal timing of antiretroviral therapy initiation in patients coinfected with HIV and tuberculosis. Expert Rev Clin Pharmacol. 2011 Mar;4(2):143-6. doi: 10.1586/ecp.11.2. No abstract available.

Reference Type DERIVED
PMID: 22115397 (View on PubMed)

Other Identifiers

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0435.3/1551

Identifier Type: -

Identifier Source: org_study_id